| 1 |
NCT03754387 |
Enrolling by invitation |
Antibiotic Therapy vs Laparscopic Appendectomy in Pediatric Chronic Appendicitis |
|
- Drug: Ceftazidime
- Procedure: appendectomy
|
Interventional
|
Not Applicable |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Participant)
- Primary Purpose: Treatment
|
- Success rate
- The rate of recurrence
- postintervention pain scores
- (and 6 more...)
|
200 |
All |
3 Years to 15 Years (Child) |
NCT03754387 |
ZunyiMU |
ATvsLAAPT |
January 1, 2019 |
January 1, 2021 |
January 1, 2022 |
November 27, 2018 |
November 28, 2018 |
|
- children's hospital of Guiyang
Guiyang, Guizhou, China - Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou, China - The first people hospital of zunyi
Zunyi, Guizhou, China
|
|
| 2 |
NCT03634904 |
Not yet recruiting |
Serum Ceftazidime Concentrations in Hemodialysis Patients |
- Bacterial Infections
- Ceftazidime
- Renal Failure Chronic Requiring Hemodialysis
|
|
Interventional
|
Not Applicable |
- Centre Hospitalier Universitaire de Charleroi
- Université Catholique de Louvain
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Trough level at 8 mg/L or 1 x the MIC
- Trough level at 32 mg/L or 4 x the MIC
- Free trough level at 8 mg/L or 1 x the MIC
- (and 16 more...)
|
20 |
All |
18 Years and older (Adult, Older Adult) |
NCT03634904 |
CHUCHARLEROIPKPD001 |
CEFTAHEMOD |
September 15, 2018 |
September 15, 2020 |
September 15, 2021 |
August 17, 2018 |
August 17, 2018 |
|
|
|
| 3 |
NCT03404739 |
Active, not recruiting |
Single- Versus Multiple-dose Antimicrobial Prophylaxis for The Prevention of Infectious Complications Associated With Peroral Endoscopic Myotomy(POEM) for Achalasia |
|
- Drug: Saline Solution
- Drug: Ceftazidime
|
Interventional
|
Phase 2
Phase 3 |
- Shanghai Zhongshan Hospital
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Prevention
|
- Infectious complications associated with POEM
- Pathogens for causing infection
- Adverse effects of antibiotics
- (and 3 more...)
|
666 |
All |
18 Years to 80 Years (Adult, Older Adult) |
NCT03404739 |
ABX for POEM |
|
October 1, 2017 |
December 2018 |
January 2019 |
January 19, 2018 |
November 7, 2018 |
|
- Zhongshan Hospital, Fudan University
Shanghai, Shanghai, China
|
|
| 4 |
NCT03790176 |
Recruiting |
ZAVI APD ELF Protocol v2.2 |
|
- Drug: Intravenous Infusion
|
Interventional
|
Phase 1 |
- Markus Zeitlinger
- Medical University of Vienna
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Other
|
- Area under the concentration time curve (AUC) from 0 to 8 hours (AUC0-8)
|
20 |
All |
18 Years to 85 Years (Adult, Older Adult) |
NCT03790176 |
Version 2.2 April 19, 2018 |
|
October 1, 2018 |
December 2019 |
December 2019 |
December 31, 2018 |
December 31, 2018 |
|
- Medical University of Vienna
Vienna, Austria
|
|
| 5 |
NCT03439124 |
Recruiting |
Ceftobiprole in the Treatment of Pediatric Patients With Pneumonia |
- Community-acquired Pneumonia
- Hospital-acquired Pneumonia
|
- Drug: Ceftobiprole medocaril
- Drug: Ceftazidime
- Drug: Ceftriaxone
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Treatment
|
- Incidence of adverse events
- Clinical cure at the TOC visit
- Microbiological eradication at the TOC visit
- (and 4 more...)
|
250 |
All |
3 Months to 17 Years (Child) |
NCT03439124 |
BPR-PIP-002 |
|
November 27, 2017 |
December 2019 |
December 2019 |
February 20, 2018 |
February 20, 2018 |
|
- Investigational Site
Pleven, Bulgaria - Investigational Site
Plovdiv, Bulgaria - Investigational Site
Ruse, Bulgaria - (and 7 more...)
|
|
| 6 |
NCT03243864 |
Recruiting |
Study of Ceftazidime-Avibactam Blood Concentrations in Intensive Care Unit Patients With Renal Failure Requiring Continuous Dialysis |
- Renal Failure
- Bacterial Infections
- Critical Illness
|
- Drug: Ceftazidime-avibactam
|
Observational
|
|
- Temple University
- Allergan
|
Other / Industry |
- Observational Model: Case-Only
- Time Perspective: Prospective
|
- Ceftazidime plasma concentrations
- Avibactam plasma concentrations
- Ceftazidime effluent concentrations
- (and 8 more...)
|
10 |
All |
18 Years and older (Adult, Older Adult) |
NCT03243864 |
866 |
|
March 13, 2017 |
March 21, 2019 |
October 21, 2019 |
August 9, 2017 |
September 12, 2018 |
|
- Temple University Hospital
Philadelphia, Pennsylvania, United States
|
|
| 7 |
NCT03133910 |
Enrolling by invitation |
Pharmacokinetics and Pharmacodynamics of Ceftazidime in Pediatric ICU Patients |
|
|
Observational
|
|
- Ann & Robert H Lurie Children's Hospital of Chicago
- Northwestern Memorial Hospital
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Duration of time that antibiotic concentration is above the minimum inhibitory concentration (T>MIC) of common gram negative bacteria
|
20 |
All |
2 Months to 18 Years (Child, Adult) |
NCT03133910 |
2016-679 |
|
March 9, 2017 |
January 2018 |
January 2019 |
April 28, 2017 |
April 28, 2017 |
|
- Ann & Robert H Lurie Childjren's Hospital of Chicago
Chicago, Illinois, United States
|
|
| 8 |
NCT02872038 |
Completed |
Comparing Cefepime Versus Cefazolin Plus Ceftazidime for CAPD-associated Peritonitis |
- Peritoneal Dialysis Associated Peritonitis
|
- Drug: Cefepime
- Drug: Cefazolin plus Ceftazidime
|
Interventional
|
Phase 4 |
- Chulalongkorn University
- The Kidney Foundation of Thailand
- Siam Pharmaceutical Co Ltd
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Primary response rate
- Initial response rate
|
154 |
All |
18 Years and older (Adult, Older Adult) |
NCT02872038 |
MONOCEF |
|
August 2015 |
November 30, 2016 |
November 30, 2016 |
August 18, 2016 |
October 31, 2017 |
|
- Chulalongkorn University
Bangkok, Thailand
|
|
| 9 |
NCT02837835 |
Completed |
Lung Concentrations of Ceftazidime in Patients With Ventilator-associated Pneumonia |
|
|
Interventional
|
Phase 3 |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- lung tissue concentration of ceftazidime
|
34 |
All |
18 Years and older (Adult, Older Adult) |
NCT02837835 |
104R04 |
CEFTALC |
March 2005 |
February 2008 |
February 2008 |
July 20, 2016 |
July 20, 2016 |
|
- Chu Reims
France, Reims, France
|
|
| 10 |
NCT02822950 |
Unknown † |
A Study of Avycaz (Ceftazidime/Avibactam) Pharmacokinetics/Pharmacodynamics (PK/PD) in Critically Ill Patients |
- Pharmacokinetics of Avycaz in ICU Patients
|
- Drug: Ceftazidime/avibactam
|
Interventional
|
Phase 1 |
- Michigan State University
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Basic Science
|
- Mean (SD) Ceftazadime/avibactam Pharmacokinetic (PK) Volume of Distribution Parameter in Intensive Care Patients
- Mean (SD) Ceftazadime/avibactam Pharmacokinetic Elimination Rate Constant Parameter in Intensive Care Patients
- Mean (SD) Ceftazadime/avibactam Pharmacokinetic Half Life Parameter in Intensive Care Patients
- (and 3 more...)
|
12 |
All |
18 Years to 90 Years (Adult, Older Adult) |
NCT02822950 |
IIT-USA-000832 |
|
January 2017 |
December 2017 |
July 2018 |
July 6, 2016 |
November 1, 2016 |
|
|
|
| 11 |
NCT02787057 |
Completed |
Vancomycin Plus Moxifloxacin Versus Vancomycin Plus Ceftazidime for the Treatment of Peritoneal Dislysis (PD)-Related Peritonitis |
- Peritoneal Dialysis Associated Peritonitis
|
- Drug: vancomycin
- Drug: moxifloxacin
- Drug: ceftazidime
|
Interventional
|
Not Applicable |
- Peking University First Hospital
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Treatment
|
- Complete cure rate
- Primary response rate
- Primary treatment failure rate
- Secondary treatment failure rate
|
80 |
All |
18 Years and older (Adult, Older Adult) |
NCT02787057 |
empirical schemes |
PD |
November 2012 |
April 2016 |
April 2016 |
June 1, 2016 |
June 1, 2016 |
|
|
|
| 12 |
NCT02732327 |
Terminated
Has Results |
Comparative Study of Ceftazidime-Avibactam Versus Standard of Care as Therapy in Febrile Neutropenic Adults With Cancer |
- Neoplasms
- Febrile Neutropenia
|
- Drug: CAZ-AVI
- Drug: Vancomycin
- Drug: Linezolid
- (and 3 more...)
|
Interventional
|
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Percentage of Patients With Favorable Clinical Response at End of Inpatient Intravenous Therapy (EOIV)
|
2 |
All |
18 Years and older (Adult, Older Adult) |
NCT02732327 |
CAZ-MD-13 |
|
May 17, 2016 |
June 27, 2016 |
June 27, 2016 |
April 8, 2016 |
July 21, 2017 |
July 21, 2017 |
- MD Anderson Cancer Center
Houston, Texas, United States
|
|
| 13 |
NCT02504827 |
Completed
Has Results |
Steady-state Pharmacokinetics of Ceftazidime/Avibactam in Cystic Fibrosis |
|
- Drug: Ceftazidime/avibactam
|
Interventional
|
Phase 4 |
- University of Southern California
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Other
|
- Peak Plasma Concentration (Cmax)
- Peak Sputum Concentration
|
12 |
All |
18 Years and older (Adult, Older Adult) |
NCT02504827 |
APP-15-01273 |
|
September 2015 |
October 2016 |
October 2016 |
July 22, 2015 |
November 27, 2018 |
November 27, 2018 |
- University of Southern California
Los Angeles, California, United States
|
|
| 14 |
NCT02497781 |
Completed
Has Results |
Evaluation of Safety, Pharmacokinetics and Efficacy of Ceftazidime and Avibactam (CAZ-AVI ) Compared With Cefepime in Children From 3 Months to Less Than 18 Years of Age With Complicated Urinary Tract Infections (cUTIs) |
- Complicated Urinary Tract Infections
|
- Drug: Ceftazidime -avibactam
- Drug: Cefepime
|
Interventional
|
Phase 2 |
- Pfizer
- PRA Health Sciences
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Treatment
|
- Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
- Percentage of Participants With Cephalosporin Class Effects and Additional Adverse Events (AEs)
- Change From Baseline in Pulse Rate at End of Intravenous Treatment (EOIV) Visit
- (and 26 more...)
|
97 |
All |
3 Months to 17 Years (Child) |
NCT02497781 |
D4280C00016
C3591005
2014-003244-13 |
|
September 24, 2015 |
September 15, 2017 |
September 15, 2017 |
July 15, 2015 |
July 11, 2018 |
April 10, 2018 |
- Rady Children's Hospital San Diego
San Diego, California, United States - Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States - ProMedica Toledo Children's Hospital
Toledo, Ohio, United States - (and 25 more...)
|
|
| 15 |
NCT02526004 |
Unknown † |
Cystic Fibrosis Microbiome-determined Antibiotic Therapy Trial in Exacerbations: Results Stratified |
|
- Drug: Ceftazidime
- Drug: Tobramycin
|
Interventional
|
Not Applicable |
- University College Cork
- Queen's University, Belfast
- University of Paris 5 - Rene Descartes
- (and 10 more...)
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
|
- The percentage change in recovery (post-exacerbation) FEV1 relative to the previous pre-exacerbation FEV1.
- The time to next pulmonary exacerbation
- The improvement in symptom burden by day 7 as determined by Cystic Fibrosis Respiratory Symptom Diary (CFRSD)
- (and 4 more...)
|
252 |
All |
16 Years to 80 Years (Child, Adult, Older Adult) |
NCT02526004 |
UCC-CFMATTERS |
CFMATTERS |
January 2015 |
September 2015 |
October 2016 |
August 18, 2015 |
August 18, 2015 |
|
- University College Cork
Cork, Ireland
|
|
| 16 |
NCT02475733 |
Completed
Has Results |
Evaluation of Safety,Pharmacokinetics and Efficacy of CAZ-AVI With Metronidazole in Children Aged 3 Months to 18 Years Old With Complicated Intra-abdominal Infections (cIAIs). |
- Complicated Intra-abdominal Infections
|
- Drug: Ceftazidime -avibactam
- Drug: Meropenem
- Drug: Metronidazole
|
Interventional
|
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Treatment
|
- Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
- Percentage of Participants With Cephalosporin Class Effects and Additional Adverse Events (AEs)
- Change From Baseline in Pulse Rate at End of Intravenous Therapy (EOIV) Visit
- (and 23 more...)
|
83 |
All |
3 Months to 17 Years (Child) |
NCT02475733 |
D4280C00015
C3591004
2014-003242-28 |
|
August 1, 2015 |
June 1, 2017 |
June 1, 2017 |
June 19, 2015 |
August 9, 2018 |
August 9, 2018 |
- CHOC Children's
Orange, California, United States - Rady Children's Hospital San Diego
San Diego, California, United States - ProMedica Toledo Children's Hospital
Toledo, Ohio, United States - (and 32 more...)
|
|
| 17 |
NCT03376529 |
Completed |
Phase 1 Study to Evaluate DDI, PK, Safety, Tolerability of SPR741 |
|
- Drug: SPR741
- Drug: Ceftazidime
- Drug: Piperacillin/tazobactam
- Drug: Aztreonam
|
Interventional
|
Phase 1 |
- Spero Therapeutics
- Simbec Research
- QPS
|
Industry / Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Pharmacokinetics: Maximum concentration (Cmax)
- Pharmacokinetics: Area under the concentration-time curve from time 0 to last measurable time-point (AUC0-t)
- Pharmacokinetics: Area under the concentration-time curve from time 0 to infinity (AUC0-inf)
- (and 20 more...)
|
27 |
All |
18 Years to 55 Years (Adult) |
NCT03376529 |
SPR741-102 |
|
November 10, 2017 |
December 19, 2017 |
December 20, 2017 |
December 18, 2017 |
January 5, 2018 |
|
- Simbec Research, Ltd.
Merthyr Tydfil,, Mid Glamorgan, United Kingdom
|
|
| 18 |
NCT02463747 |
Unknown † |
Short vs Prolonged Antibiotic Treatment for Hospitalized Hemato-oncology Patients With Febrile Neutropenia |
|
- Drug: Piperacillin/tazobactam
- Drug: Ceftazidim
- Drug: Meropenem
- Drug: Vancomycin
|
Interventional
|
Phase 4 |
- Tel-Aviv Sourasky Medical Center
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- A successful response to treatment
- Breakthrough fever or Additional bacteremia
- Clostridium difficile infection
- (and 4 more...)
|
110 |
All |
18 Years to 90 Years (Adult, Older Adult) |
NCT02463747 |
0143-15-TLV |
RR |
June 2015 |
June 2017 |
July 2017 |
June 4, 2015 |
June 4, 2015 |
|
- Tel-Aviv Sourasky Medicak center / BMT Unit
Tel-Aviv, Israel
|
|
| 19 |
NCT02593201 |
Recruiting |
The Efficacy of Prolonged Antibiotic Therapy for the Prevention of Relapsing Peritonitis in Peritoneal Dialysis Patients With High Dialysis Effluent Bacterial DNA Fragment Levels |
|
- Drug: Extended antibiotics (cefazolin or ceftazidime)
- Drug: Usual antibiotics (cefazolin or ceftazidime)
|
Interventional
|
Phase 4 |
- Chinese University of Hong Kong
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- relapsing peritonitis episodes
- repeat peritonitis episodes
- recurrent peritonitis episodes
- (and 5 more...)
|
360 |
All |
18 Years and older (Adult, Older Adult) |
NCT02593201 |
PPDNA |
|
February 26, 2016 |
December 31, 2022 |
June 30, 2023 |
November 2, 2015 |
February 4, 2019 |
|
- Department of Medicine & Therapeutics, Prince of Wales Hospital
Shatin, Hong Kong
|
|
| 20 |
NCT02840136 |
Suspended |
LC-MS/MS Based Method Development for the Monitoring of Antibiotic Concentrations in Sputum of Cystic Fibrosis Patients |
|
- Drug: Piperacillin-tazobactam combination product
- Drug: Meropenem
- Drug: Ceftazidime
|
Interventional
|
Not Applicable |
- University Ghent
- King Baudouin Foundation
- Belgische Vereniging voor Strijd tegen Mucoviscidose
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Basic Science
|
- Concentration changes induced by aerosol use
- Antibiotic distribution in single sputum sample
- Antibiotic concentration in subsequently collected samples from the same patient
|
40 |
All |
12 Years and older (Child, Adult, Older Adult) |
NCT02840136 |
EC UZG 2015/1504
B670201526932 |
|
February 2016 |
December 2019 |
December 2020 |
July 21, 2016 |
June 13, 2018 |
|
- Ghent University
Ghent, Oost-Vlaanderen, Belgium
|
|
| 21 |
NCT01893346 |
Completed
Has Results |
Safety and Tolerability of Ceftazidime-Avibactam for Pediatric Patients With Suspected or Confirmed Infections |
|
|
Interventional
|
Phase 1 |
- Pfizer
- Forest Laboratories
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Basic Science
|
- Pharmacokinetic Parameters of Avibactam and Ceftazidime for Cohort 1 and 2: AUC
- Pharmacokinetic Parameters of Avibactam and Ceftazidime for Cohort 1 and 2: Cmax
|
35 |
All |
3 Months to 17 Years (Child) |
NCT01893346 |
D4280C00014 |
|
July 2013 |
October 2014 |
October 2014 |
July 9, 2013 |
September 6, 2017 |
May 27, 2015 |
- Research Site
Little Rock, Arkansas, United States - Research Site
Orange, California, United States - Research Site
San Diego, California, United States - (and 7 more...)
|
|
| 22 |
NCT01920399 |
Completed |
A Phase I Study to Assess the Safety, Tolerability and PK of Ceftazidime-Avibactam in Healthy Chinese Subjects |
|
- Drug: CAZ-AVI
- Drug: 0.9% Normal Saline
|
Interventional
|
Phase 1 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Other
|
- Safety and Tolerability:Adverse events, vital signs, ECGs, clinical laboratory measurements, physical examinations, oral body temperature
- Plasma PK parameters for CAZ and AVI of single dose: Cmax, tmax, Clast, tlast, AUC(0-t), AUC, AUC(0-8), λz, t1/2, Vss, Vz, CL, MRT, etc.
- Plasma PK parameters for CAZ and AVI of multi dose: the trough concentration Cmin
- (and 2 more...)
|
42 |
All |
18 Years to 45 Years (Adult) |
NCT01920399 |
D4280C00020 |
|
October 2013 |
November 2013 |
November 2013 |
August 12, 2013 |
September 5, 2017 |
|
- Research Site
Shanghai, China
|
|
| 23 |
NCT01808092 |
Completed
Has Results |
A Study Comparing Ceftazidime-Avibactam Versus Meropenem in Hospitalized Adults With Nosocomial Pneumonia |
- Nosocomial Pneumonia (NP)
- Ventilator-associated Pneumonia (VAP)
|
- Drug: ceftazidim-avibactam (CAZ-AVI, experimental product)
- Drug: meropenem (active comparator)
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- The Number of Patients With Clinical Cure at Test-of-cure (TOC) Visit in the Clinically Modified Intent-to-treat Analysis Set (Co-primary Analyses)
- The Number of Patients With Clinical Cure at Test-of-cure (TOC) Visit in the Clinically Evaluable at TOC Analysis Set (Co-primary Analyses)
- The Number of Patients With Clinical Cure at Test-of-cure (TOC) Visit in the Microbiologically Modified Intent-to-treat Analysis Set
- (and 46 more...)
|
969 |
All |
18 Years to 90 Years (Adult, Older Adult) |
NCT01808092 |
D4281C00001 |
|
April 2013 |
January 2016 |
January 2016 |
March 11, 2013 |
September 6, 2017 |
February 3, 2017 |
- Research Site
Buenos Aires, Argentina - Research Site
Cordoba, Argentina - Research Site
Florida, Argentina - (and 122 more...)
|
|
| 24 |
NCT01784445 |
Completed |
Post ERCP Pancreatitis Prevention in Average Risk Patients |
|
|
Interventional
|
Phase 4 |
- University Hospital Rijeka
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Prevention
|
- Incidence of PEP in the group of patients receiving Ceftazidime versus incidence of PEP in the group of patients receiving Diclophenac potassium
|
124 |
All |
18 Years and older (Adult, Older Adult) |
NCT01784445 |
PEP 2013 |
|
June 2013 |
September 2014 |
February 2015 |
February 5, 2013 |
April 8, 2015 |
|
- Clinical Hospital Centre
Rijeka, Kresimirova 42, Croatia
|
|
| 25 |
NCT01726023 |
Completed
Has Results |
Compare Ceftazidime-Avibactam + Metronidazole vs Meropenem for Hospitalized Adults With Complicated Intra-Abd Infections |
- Complicated Intra-abdominal Infection
|
- Drug: Ceftazidime-avibactam
- Drug: metronidazole
- Drug: Meropenem
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- The Proportion of Patients With Clinical Cure at the Test of Cure (TOC) Visit in the Clinically Evaluable (CE) Analysis Set.
- The Proportion of Patients With Clinical Cure at the End of Treatment (EOT) Visit in the Microbiologically Evaluable (ME) Analysis Set.
- The Proportion of Patients With Clinical Cure at the Test of Cure (TOC) Visit in the Microbiologically Evaluable (ME) Analysis Set.
- (and 38 more...)
|
486 |
All |
18 Years to 90 Years (Adult, Older Adult) |
NCT01726023 |
D4280C00018
2011-003893-97 |
RECLAIM3 |
January 2013 |
March 2015 |
March 2015 |
November 14, 2012 |
September 6, 2017 |
April 14, 2016 |
- Research Site
Baotou, China - Research Site
Beijing, China - Research Site
Changsha, China - (and 27 more...)
|
|
| 26 |
NCT01785641 |
Unknown † |
Single Versus Combined Antibiotic Therapy for Bacterial Peritonitis in CAPD Patients |
|
- Drug: ceftazidime+ciprofloxacin
- Drug: ceftazidime monotherapy
- Drug: cefazolin+gentamicin
- Drug: cefazolin monotherapy
|
Interventional
|
Not Applicable |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Participant)
- Primary Purpose: Treatment
|
- relapse or recurrent rate
|
300 |
All |
15 Years to 75 Years (Child, Adult, Older Adult) |
NCT01785641 |
RA56/006 |
|
December 2012 |
December 2013 |
December 2013 |
February 7, 2013 |
February 7, 2013 |
|
- Chulalongkorn university
Bangkok, Thailand
|
|
| 27 |
NCT01644643 |
Completed
Has Results |
Ceftazidime-Avibactam for the Treatment of Infections Due to Ceftazidime Resistant Pathogens |
- Complicated Urinary Tract Infection
- Complicated Intra-abdominal Infection
|
- Drug: Ceftazidime - Avibactam ( CAZ-AVI)
- Drug: Best Available Therapy
- Drug: Metronidazole
|
Interventional
|
Phase 3 |
- Pfizer
- Forest Laboratories
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Clinical Response at Test of Cure (TOC) in Microbiological Modified Intent-to-treat (mMITT) Analysis Set
- Clinical Response at End of Treatment (EOT) in mMITT Analysis Set.
- Clinical Response at Follow-up 1 (FU1) in mMITT Analysis Set
- (and 35 more...)
|
345 |
All |
18 Years to 90 Years (Adult, Older Adult) |
NCT01644643 |
D4280C00006
2012-000726-21 |
|
January 2013 |
September 2014 |
September 2014 |
July 19, 2012 |
September 29, 2017 |
December 14, 2015 |
- Research Site
Shreveport, Louisiana, United States - Research Site
Lima, Ohio, United States - Research Site
El Talar, Argentina - (and 43 more...)
|
|
| 28 |
NCT01789528 |
Completed |
A Study to Investigate the Effect of Administration of Ceftazidime-avibactam (CAZ-AVI) and Ceftaroline Fosamil -Avibactam (CXL) on the Intestinal Flora of Healthy Volunteers |
- Pharmacokinetics
- Open Label
- CAZ-AVI
- (and 3 more...)
|
|
Interventional
|
Phase 1 |
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Basic Science
|
- Changes in the intestinal flora of healthy subjects after administration of ceftazidime-avibactam (CAZ-AVI) and ceftaroline fosamil -avibactam (CXL).
- Safety and tolerability
- Pharmacokinetics of CAZ-AVI in healthy volunteers
- (and 3 more...)
|
48 |
All |
18 Years to 45 Years (Adult) |
NCT01789528 |
D4280C00023 |
|
August 2013 |
March 2014 |
March 2014 |
February 12, 2013 |
September 5, 2017 |
|
- Research Site
Stockholm, Sweden
|
|
| 29 |
NCT01599806 |
Completed
Has Results |
Ceftazidime-Avibactam Compared With Doripenem Followed by Oral Therapy for Hospitalized Adults With Complicated UTIs (Urinary Tract Infections) |
- Complicated Urinary Tract Infection (cUTI) Including Acute Pyelonephritis
|
- Drug: Ceftazidime - Avibactam ( CAZ-AVI)
- Drug: Doripenem
- Drug: Either switch to oral therapy: 500 mg of Ciprofloxacin (oral)
- Drug: or switch to oral therapy: 800 mg/160 mg of sulfamethoxazole/trimethoprim (oral)
|
Interventional
|
Phase 3 |
- Pfizer
- Forest Laboratories
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Patient-reported Symptomatic Response at Day 5 (mMITT Analysis Set): Non-inferiority Hypothesis Test
- Combined Patient-reported Symptomatic and Microbiological Response at TOC (mMITT Analysis Set): Non-inferiority Hypothesis Test
- Per-patient Microbiological Response at TOC (mMITT Analysis Set): Non-inferiority Hypothesis Test
- (and 60 more...)
|
641 |
All |
18 Years to 90 Years (Adult, Older Adult) |
NCT01599806 |
D4280C00004
2011-005722-21 |
|
October 2012 |
August 2014 |
August 2014 |
May 16, 2012 |
September 6, 2017 |
March 2, 2016 |
- Research Site
Detroit, Michigan, United States - Research Site
Saint Louis, Missouri, United States - Research Site
Indiana, Pennsylvania, United States - (and 57 more...)
|
|
| 30 |
NCT01601093 |
Unknown † |
Study on Ceftazidime and Sulbactam Sodium for Injection (2:1) for Treatment of Respiratory and Urinary Tract Infection |
- Respiratory Tract Infections
- Urinary Tract Infections
|
- Drug: High dose
- Drug: Low dose
- Drug: Cefoperazone and Sulbactam Sodium (CFP/SUB)
|
Interventional
|
Phase 2 |
- Xiangbei Welman Pharmaceutical Co., Ltd
|
Industry |
- Allocation: Randomized
- Intervention Model: Factorial Assignment
- Masking: Single (Participant)
- Primary Purpose: Treatment
|
- The rate of bacterial clearance
- Number of participants with Adverse Events
|
288 |
All |
18 Years to 70 Years (Adult, Older Adult) |
NCT01601093 |
2008L03354 |
CAZ-SBT |
November 2011 |
August 2013 |
November 2013 |
May 17, 2012 |
June 5, 2013 |
|
- the First Affiliated Hospital With Medical University
Nanjing, Jiangsu, China
|
|
| 31 |
NCT01595438 |
Completed
Has Results |
Ceftazidime-Avibactam Compared With Doripenem Followed by Oral Therapy for Hospitalized Adults With Complicated UTIs (Urinary Tract Infections) |
- Complicated Urinary Tract Infection (cUTI) Including Acute Pyelonephritis
|
- Drug: Ceftazidime - Avibactam ( CAZ-AVI)
- Drug: Doripenem
- Drug: Either switch to oral therapy: 500 mg of Ciprofloxacin (oral)
- Drug: or switch to oral therapy: 800 mg/160 mg of sulfamethoxazole/trimethoprim (oral)
|
Interventional
|
Phase 3 |
- Pfizer
- Forest Laboratories
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Patient-reported Symptomatic Response at Day 5 (mMITT Analysis Set): Non-inferiority Hypothesis Test
- Combined Patient-reported Symptomatic and Microbiological Response at TOC (mMITT Analysis Set): Non-inferiority Hypothesis Test
- Per-patient Microbiological Response at TOC (mMITT Analysis Set): Non-inferiority Hypothesis Test
- (and 60 more...)
|
598 |
All |
18 Years to 90 Years (Adult, Older Adult) |
NCT01595438 |
D4280C00002
2011-005721-43 |
|
October 2012 |
August 2014 |
August 2014 |
May 10, 2012 |
September 6, 2017 |
March 9, 2016 |
- Research Site
Sylmar, California, United States - Research Site
Royal Oak, Michigan, United States - Research Site
Lima, Ohio, United States - (and 81 more...)
|
|
| 32 |
NCT01828892 |
Unknown † |
Glue Application in the Treatment of Low-Output Fistulas |
- Low-output External Gastrointestinal Fistula
|
- Procedure: Endoscopy exploration and glue application
- Procedure: Endoscopy exploration
- Drug: Antibiotics (ceftazidime, cefotaxime, or meropenem, with or without vancomycin)
- Dietary Supplement: Nutrition support
|
Interventional
|
Not Applicable |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Closure rates up to 14 days
- Number of adverse events
|
30 |
All |
18 Years to 65 Years (Adult, Older Adult) |
NCT01828892 |
20120819 |
FG-treatment |
March 2014 |
June 2017 |
December 2017 |
April 11, 2013 |
June 10, 2015 |
|
- Jinling Hospital
Nanjing, Jiangsu, China
|
|
| 33 |
NCT01507532 |
Withdrawn |
Pharmacokinetic Assessment of Ceftazidime in Intermittent Hemodialysis Patients |
|
- Other: pharmacokinetic monitoring
|
Interventional
|
Phase 4 |
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Other
|
- Determine clearance of ceftazidime in hemodialysis
|
0 |
All |
Child, Adult, Older Adult |
NCT01507532 |
STU00056702 |
|
January 2012 |
January 2016 |
January 2016 |
January 11, 2012 |
March 20, 2018 |
|
- Northwestern Memorial Hospital
Chicago, Illinois, United States
|
|
| 34 |
NCT02287493 |
Completed |
Pharmacokinetics of Selected Antiinfectives During Sustained Low-efficiency Dialysis (SLED) |
- Replacement Therapy, Renal
|
- Other: Pharmacokinetic Analysis
|
Observational
|
|
- Universitätsklinikum Hamburg-Eppendorf
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Serum levels of meropenem or ceftazidim during SLED
- 28-day mortality, for inpatients
- Length of stay at the ICU and in hospital
- Clinical and microbiological cure of infections
|
35 |
All |
18 Years and older (Adult, Older Adult) |
NCT02287493 |
PV4244 |
PhA-SLED |
July 2013 |
December 2016 |
December 2016 |
November 10, 2014 |
June 6, 2017 |
|
- University Medical Center Hamburg-Eppendorf
Hamburg, Germany
|
|
| 35 |
NCT01499290 |
Completed
Has Results |
Compare Ceftazidime-Avibactam + Metronidazole Versus Meropenem for Hospitalized Adults With Complicated Intra-Abdominal Infections |
- Complicated Intra-Abdominal Infection
|
- Drug: CAZ-AVI
- Drug: Metronidazole
- Drug: Meropenem
|
Interventional
|
Phase 3 |
- Pfizer
- Forest Laboratories
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Clinical Response at the Test of Cure (TOC) Visit in the Microbiologically Modified Intent-To-Treat (mMITT) Analysis Set (Primary Outcome for FDA).
- Clinical Response at the TOC Visit in the Modified Intent-To-Treat Analysis Set (Co-primary Outcome for Rest of World [ROW]).
- Clinical Response at the TOC Visit in the Clinically Evaulable (CE) Analysis Set (Co-primary Outcome for Rest of World [ROW]).
- (and 10 more...)
|
493 |
All |
18 Years to 90 Years (Adult, Older Adult) |
NCT01499290 |
D4280C00001
2011-003893-97 |
|
March 2012 |
April 2014 |
April 2014 |
December 26, 2011 |
September 6, 2017 |
March 1, 2016 |
- Research Site
Chula Vista, California, United States - Research Site
San Diego, California, United States - Research Site
Saint Louis, Missouri, United States - (and 54 more...)
|
|
| 36 |
NCT01455246 |
Terminated |
Daptomycin + Meropenem Versus Ceftazidime in the Treatment of Nosocomial Spontaneous Bacterial Peritonitis |
- Cirrhosis
- Ascites
- Nosocomial Spontaneous Bacterial Peritonitis
|
- Drug: Daptomycin + Meropenem
- Drug: Ceftazidime
|
Interventional
|
Phase 2
Phase 3 |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- The primary end-point of the study is the response to therapy
- Mortality during hospitalization
- 30 days mortality
- 90 days mortality
|
32 |
All |
18 Years to 75 Years (Adult, Older Adult) |
NCT01455246 |
2059P
2010-019625-34 |
|
October 2010 |
April 2014 |
July 2014 |
October 19, 2011 |
October 15, 2014 |
|
- Dept. of Clinical and Experimental Medicine, University of Padova
Padova, PD, Italy
|
|
| 37 |
NCT01430910 |
Completed |
A Study to Assess the Levels of Two Antibiotics in the Blood When Given Together and Separately |
|
- Drug: CAZ104
- Drug: Avibactam
- Drug: Ceftazidime
|
Interventional
|
Phase 1 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Basic Science
|
- Part A: Single- and multiple-dose pharmacokinetics of Avibactam. Plasma pharmacokinetic variables will be measured including maximum plasma concentration (Cmax)
- Part A: Single- and multiple-dose pharmacokinetics of Avibactam. Plasma pharmacokinetic variables will be measured including time of Cmax (tmax)
- Part A: Single- and multiple-dose pharmacokinetics of Avibactam. Plasma pharmacokinetic variables will be measured including minimum plasma concentration (Cmin)
- (and 75 more...)
|
43 |
All |
18 Years to 50 Years (Adult) |
NCT01430910 |
D4280C00011 |
|
September 2011 |
October 2012 |
October 2012 |
September 9, 2011 |
September 1, 2017 |
|
- Research site
London, United Kingdom
|
|
| 38 |
NCT01395420 |
Completed |
Study to Assess the Concentration of Avibactam and Ceftazidime in Epithelial Lining Fluid and Plasma |
|
|
Interventional
|
Phase 1 |
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Basic Science
|
- To measure and compare the concentration of Avibactam and Ceftazidime in ELF and plasma
- To evaluate safety and tolerability of Avibactam and Ceftazidime
|
45 |
All |
18 Years to 50 Years (Adult) |
NCT01395420 |
D4280C00009 |
|
August 2011 |
July 2012 |
July 2012 |
July 15, 2011 |
September 1, 2017 |
|
- Research Site
London, United Kingdom
|
|
| 39 |
NCT01344512 |
Completed |
Population Pharmacokinetics of Anti-infectious Drugs in Children |
- Pediatrics
- Ceftazidime
- Ciprofloxacin
- Voriconazole
|
- Drug: Ceftazidime
- Drug: Ciprofloxacin
- Drug: Voriconazole
|
Interventional
|
Not Applicable |
- University Hospital, Bordeaux
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Population pharmacokinetic parameters and factors explaining variability
- Covariability factors explaining the variability (age, biological data, pharmacokinetics factors, associated treatments...)
|
214 |
All |
up to 6 Years (Child) |
NCT01344512 |
CHUBX 2010/36 |
PHARMA-A |
June 2011 |
September 2014 |
September 2014 |
April 29, 2011 |
March 18, 2015 |
|
- CHU de Bordeaux, Hôpital Pellegrin
Bordeaux, France - Hospices Civils de Lyon
Bron, France - CHU Clermont Ferrand
Clermont Ferrand, France - (and 11 more...)
|
|
| 40 |
NCT01291602 |
Completed |
A Study to Assess the Safety, Tolerability and Pharmacokinetics of NXL104 Alone and in Combination With Ceftazidime Administered as Single and Repeated Intravenous Doses in Healthy Japanese Subjects |
- Healthy Male and Female Japanese Volunteers
|
- Drug: NXL104
- Drug: CAZ104
- Drug: Placebo
|
Interventional
|
Phase 1 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Basic Science
|
- Adverse events will be monitored as a measure of safety and tolerability
- Vital signs, physical examinations, clinical laboratory tests, 12 lead electrocardiogram (ECG) and digital ECG will be assessed as a measure of safety and tolerability
- The pharmacokinetic parameters of plasma of NXL104 alone or in combination with ceftazidime
- (and 2 more...)
|
15 |
All |
20 Years to 45 Years (Adult) |
NCT01291602 |
D4280C00010 |
|
February 2011 |
April 2011 |
April 2011 |
February 8, 2011 |
September 1, 2017 |
|
- Research Site
Glendale, California, United States - Research Site
Baltimore, Maryland, United States
|
|
| 41 |
NCT01290900 |
Completed |
A Single-centre, Randomised, Double-blind, Placebo-controlled, Four Way Crossover Phase I Study to Investigate the Effect on QT/QTc Interval of Ceftazidime NXL104 or Ceftaroline Fosamil NXL104, Compared With Placebo, Using Moxifloxacin (Avelox®) as a Positive Control, in Healthy Male Volunteers |
|
- Drug: NXL104
- Drug: Ceftaroline
- Drug: Placebo Infusion
- (and 2 more...)
|
Interventional
|
Phase 1 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Basic Science
|
- To investigate the effect of supratherapeutic doses of ceftazidime NXL104 (CAZ104) or ceftaroline fosamil NXL104 (CXL104) on the QT interval (QTcF).
- To investigate the effect of CAZ104 and CXL104, on additional ECG variables (heart rate, RR, PR, QRS, QT, and QTcB).
- To assess the PK of NXL104, ceftaroline, ceftazidime and moxifloxacin by determination where applicable of Cmax, tmax, AUC(0-t), AUC, t½, CL, CL/F, Vss, and Vz/F.
|
54 |
Male |
18 Years to 45 Years (Adult) |
NCT01290900 |
D4280C00007 |
|
February 2011 |
May 2011 |
May 2011 |
February 7, 2011 |
September 1, 2017 |
|
- Research Site
Overland Park, Kansas, United States
|
|
| 42 |
NCT01534247 |
Completed |
A Study to Assess the Levels of CAZ-AVI and Metronidazole in the Blood When Given Together and Separately |
|
- Drug: CAZ-AVI
- Drug: metronidazole
- Drug: CAZ-AVI + metronidazole
|
Interventional
|
Phase 1 |
- Pfizer
- Forest Laboratories
|
Industry |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Primary Purpose: Basic Science
|
- Profile of pharmacokinetic of ceftazidime, avibactam and metronidazole when administering CAZ-AVI plus metronidazole in combination compared to administration of individual components
- To assess safety and tolerability of CAZ-AVI and metronidazole when administered as a 2- and 1-hour infusion, respectively, every 8 hours by assessment of adverse events, lab, vital signs, ECG, physical examination
|
28 |
All |
18 Years to 50 Years (Adult) |
NCT01534247 |
D4280C00012 |
|
February 2012 |
July 2012 |
July 2012 |
February 16, 2012 |
September 5, 2017 |
|
- Research site
Overland Park, Kansas, United States
|
|
| 43 |
NCT00921024 |
Completed
Has Results |
Safety and Efficacy of IV CXA-101 and IV Ceftazidime in Patients With Complicated Urinary Tract Infections |
- Complicated Urinary Tract Infection
|
- Drug: CXA-101
- Drug: Ceftazidime
|
Interventional
|
Phase 2 |
- Cubist Pharmaceuticals LLC
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Microbiological Response at the Test of Cure (TOC) Visit in the Microbiological Modified Intent-to-Treat (mMITT) Population
- Microbiological Response at the TOC Visit in the Microbiologically Evaluable (ME) Population.
|
129 |
All |
18 Years to 90 Years (Adult, Older Adult) |
NCT00921024 |
7625-001
CXA 101-03 |
|
June 30, 2009 |
February 25, 2010 |
March 11, 2010 |
June 16, 2009 |
October 18, 2018 |
January 15, 2015 |
- Healthcare Partners Medical Group
Los Angeles, California, United States - Compass Research, LLC
Orlando, Florida, United States - Atlanta Institute for Medical Research, Inc.
Decatur, Georgia, United States - (and 18 more...)
|
|
| 44 |
NCT00786305 |
Completed |
Nebulized Ceftazidime and Amikacin in Ventilator Associated Pneumonia |
|
- Drug: ceftazidime and amikacin
|
Interventional
|
Phase 2 |
- Groupe Hospitalier Pitie-Salpetriere
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Bacterial killing
- Changes of lung aeration
|
40 |
All |
18 Years and older (Adult, Older Adult) |
NCT00786305 |
NATB-2004 |
|
October 2004 |
September 2008 |
November 2008 |
November 6, 2008 |
November 6, 2008 |
|
- Intensive care unit, Department of anesthesiology, La pitie-Salpetriere hospital
Paris, France
|
|
| 45 |
NCT00752882 |
Unknown † |
Ceftazidime Pharmacokinetic in Cerebrospinal Fluid Between Continuous and Intermittent Administration |
- Pseudomonas Aeruginosa Meningitis
|
|
Interventional
|
Phase 2 |
- University Hospital, Clermont-Ferrand
|
Other |
- Allocation: Randomized
- Intervention Model: Single Group Assignment
- Masking: Single
- Primary Purpose: Treatment
|
|
24 |
All |
18 Years and older (Adult, Older Adult) |
NCT00752882 |
CHU-0025 |
|
|
|
June 2009 |
September 16, 2008 |
January 19, 2011 |
|
|
|
| 46 |
NCT00752219 |
Completed
Has Results |
Prospective Multicenter Doubleblind Randomized Study of NXL104/Ceftazidime + Metronidazole vs. Meropenem in Treatment of Complicated Intra-abdominal Infections |
- Complicated Intra-abdominal Infections
|
- Drug: ceftazidime/NXL104 + metronidazole
- Drug: meropenem
|
Interventional
|
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Number of Participants With Clinical Response at the Test of Cure (TOC) Visit
- Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
- Number of Participants With Clinical Response at the End of Intravenous (IV) Therapy
- (and 7 more...)
|
204 |
All |
18 Years to 65 Years (Adult, Older Adult) |
NCT00752219 |
NXL-104/2002
C3591014 |
|
March 31, 2009 |
November 30, 2009 |
December 31, 2009 |
September 15, 2008 |
July 3, 2018 |
July 3, 2018 |
- University of Southern California
Los Angeles, California, United States - Cedars-Sinai Medical Center Dept of Surgery
Los Angeles, California, United States - Michael S. Somero Research Division
Palm Springs, California, United States - (and 42 more...)
|
|
| 47 |
NCT00690378 |
Completed
Has Results |
Comparative Study of NXL104/Ceftazidime Versus Comparator in Adults With Complicated Urinary Tract Infections |
- Complicated Urinary Tract Infection
|
- Drug: NXL104/ceftazidime
- Drug: Imipenem/Cilastatin
|
Interventional
|
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Investigator)
- Primary Purpose: Treatment
|
- Number of Participants With Microbiological Outcome at the Test of Cure (TOC) Visit
- Clinical Outcome in Clinically Evaluable (CE) Patients at the End of Intravenous (IV) Therapy Visit
- Clinical Outcome in CE Patients at the TOC Visit
- (and 17 more...)
|
137 |
All |
18 Years to 65 Years (Adult, Older Adult) |
NCT00690378 |
NXL104/2001
C3591013 |
|
November 2008 |
June 2010 |
July 2010 |
June 4, 2008 |
May 25, 2018 |
May 25, 2018 |
- Alabama Research Center
Birmingham, Alabama, United States - Southeast Alabama Medical Center
Dothan, Alabama, United States - Providence Hospital
Mobile, Alabama, United States - (and 56 more...)
|
|
| 48 |
NCT01044719 |
Unknown † |
Duration of Antibiotics in Infective Exacerbations of Cystic Fibrosis |
|
- Drug: Ceftazidime
- Drug: Tobramycin
- Drug: Meropenem
|
Interventional
|
Phase 4 |
|
Other |
- Allocation: Randomized
- Intervention Model: Single Group Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Treatment failure at completion of antibiotic course
- Time to next exacerbation
- Change in Spirometry
- (and 5 more...)
|
240 |
All |
16 Years and older (Child, Adult, Older Adult) |
NCT01044719 |
RBHADS001 |
|
January 2010 |
October 2010 |
April 2011 |
January 8, 2010 |
April 13, 2010 |
|
- Department of Cystic Fibrosis, Royal Brompton Hospital
London, United Kingdom
|
|
| 49 |
NCT00579956 |
Unknown † |
A Randomized Double Blinded Comparison of Ceftazidime and Meropenem in Severe Melioidosis |
|
- Drug: Meropenem
- Drug: Ceftazidime
|
Interventional
|
Not Applicable |
- University of Oxford
- Mahidol University
- Wellcome Trust
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- All cause mortality
- All cause mortality in patients culture positive for melioidosis
- Switch of antimicrobial therapy
- (and 3 more...)
|
750 |
All |
15 Years and older (Child, Adult, Older Adult) |
NCT00579956 |
OXTREC 018-06 |
ATOM |
December 2007 |
September 2010 |
September 2010 |
December 24, 2007 |
June 4, 2008 |
|
- Sappasithiprasong Hospital
Ubonratchathani, Ubon, Thailand - Udon Thani General Hospital
Udon Thani, Thailand
|
|
| 50 |
NCT00823238 |
Completed |
Comparison of Antibiotics for Pseudomonas in Early CF |
|
- Drug: ceftazidime and tobramycin
- Drug: inhaled tobramycin
|
Interventional
|
Phase 1 |
- University of North Carolina, Chapel Hill
- Cystic Fibrosis Foundation
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
|
21 |
All |
3 Months to 16 Years (Child) |
NCT00823238 |
GCRC2197 |
CAPEC |
July 2004 |
May 2008 |
May 2008 |
January 15, 2009 |
April 18, 2011 |
|
|
|
| 51 |
NCT00333385 |
Terminated |
Continuous Versus Short Infusions of Ceftazidime in Cystic Fibrosis |
- Cystic Fibrosis
- Pseudomonas Aeruginosa
- Pulmonary Exacerbation
|
|
Interventional
|
Phase 4 |
- Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche
- Vaincre la Mucoviscidose
- GlaxoSmithKline
- (and 2 more...)
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Change in forced expiratory volume in 1s (FEV1) between the beginning and the end of the IV antibiotic course, expressed as a percentage of the predicted normal value
- the interval between 2 successive IV antibiotic courses
- quality of life scores
- (and 3 more...)
|
120 |
All |
8 Years and older (Child, Adult, Older Adult) |
NCT00333385 |
01648 |
|
October 2001 |
|
April 2004 |
June 5, 2006 |
June 5, 2006 |
|
- CHU Grenoble
Grenoble, France - Centre hospitalier Dr Schaffner
Lens, France - Hopital Albert Calmette
Lille, France - (and 12 more...)
|
|
| 52 |
NCT00229008 |
Completed |
Ceftobiprole in Hospital Acquired Pneumonia |
|
- Drug: ceftobiprole plus placebo
- Drug: linezolid plus ceftazidime
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Clinical cure rate (the ratio of the number of clinically cured patients to the total number of patients in the population)
- Microbiological eradication rate
- Clinical cure rate
- (and 2 more...)
|
106 |
All |
18 Years and older (Adult, Older Adult) |
NCT00229008 |
CR005140
BAP00248 |
|
November 2005 |
May 2007 |
May 2007 |
September 29, 2005 |
September 3, 2012 |
|
|
|
| 53 |
NCT00173901 |
Unknown † |
Adverse Drug Reactions of Different Brands of Ceftazidime Injection |
|
|
Interventional
|
Phase 4 |
- National Taiwan University Hospital
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single
- Primary Purpose: Treatment
|
- The adverse drug reactions of ceftazidime
- The effectiveness of ceftazidime
|
536 |
All |
1 Year to 95 Years (Child, Adult, Older Adult) |
NCT00173901 |
900104 |
|
March 2001 |
|
April 2002 |
September 15, 2005 |
September 15, 2005 |
|
- National Taiwan University Hospital
Taipei, Taiwan
|
|
| 54 |
NCT00210964 |
Completed |
Ceftobiprole in Hospital Acquired Pneumonia |
|
- Drug: ceftobiprole plus placebo
- Drug: linezolid plus ceftazidime
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double
- Primary Purpose: Treatment
|
- Clinical cure rate (the ratio of the number of clinically cured patients to the total number of patients in the population)
- Microbiological eradication rate
- Clinical cure rate
- (and 2 more...)
|
781 |
All |
18 Years and older (Adult, Older Adult) |
NCT00210964 |
CR005032
BAP00307 |
|
April 2005 |
May 2007 |
May 2007 |
September 21, 2005 |
September 3, 2012 |
|
|
|
| 55 |
NCT00210899 |
Completed |
Ceftobiprole in the Treatment of Resistant Staphylococcus Aureus Skin and Skin Structure Infections |
- Skin Diseases, Infectious
- Skin Diseases, Bacterial
- Staphylococcal Skin Infections
|
- Drug: ceftobiprole medocaril
- Drug: Vancomycin plus Ceftazidime
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Clinical cure rate (the ratio of the number of clinically cured patients to the total number of patients in the population) at 7-14 days after the end of therapy.
|
828 |
All |
18 Years and older (Adult, Older Adult) |
NCT00210899 |
CR005029
BAP00414 |
|
September 2005 |
October 2006 |
October 2006 |
September 21, 2005 |
July 26, 2012 |
|
|
|
| 56 |
NCT00195923 |
Completed |
Prospective Randomized Evaluation of Antibiotic Regimen Following Appendectomy for Perforated Appendicitis |
|
- Drug: Ampicillin, gentamicin, clindamycin, flagyl, ceftazidime
|
Observational
|
|
- Children's Mercy Hospital Kansas City
|
Other |
- Observational Model: Defined Population
- Observational Model: Natural History
- Time Perspective: Cross-Sectional
- Time Perspective: Prospective
|
|
100 |
All |
1 Month to 18 Years (Child, Adult) |
NCT00195923 |
04-12-149 |
|
April 2005 |
|
January 2007 |
September 20, 2005 |
April 6, 2007 |
|
- The Children’s Mercy Hospital
Kansas CIty, Missouri, United States
|
|
| 57 |
NCT00360607 |
Completed |
A Comparative Phase IV Study Evaluating Efficacy & Safety Of Magnex(Cefoperazone-Sulbactam) In Intraabdominal Infections |
|
- Drug: Magnex (Sulbactam Sodium/Cefoperazone Sodium 1:1) Pfizer Ltd.
- Drug: Fortum (Ceftazidime for injection USP) Glaxo Smith Kline Pharmaceuticals Limited
- Drug: Metrogyl (Metronidazole Injection IP) J.B.Chemicals & Pharmaceuticals Ltd.
- Drug: Mikacin (Amikacin Sulphate Injection IP) Aristo Pharmaceuticals Ltd.
|
Interventional
|
Phase 4 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Proportion of clinical efficacy-evaluable subjects who present with continued resolution at the 30-day follow-up visit.
- Adverse events as observed by the investigator or volunteered as responses to unsolicited and non-leading questions.
- Vital signs including systolic and diastolic blood pressures, pulse rate and respiratory rate.
- (and 7 more...)
|
307 |
All |
12 Years and older (Child, Adult, Older Adult) |
NCT00360607 |
A1891002 |
|
July 2004 |
|
April 2005 |
August 4, 2006 |
December 2, 2008 |
|
- Pfizer Investigational Site
Ahmedabad, Gujarat, India - Pfizer Investigational Site
Ahmedabad, Gujarat, India - Pfizer Investigational Site
Ahmedabad, Gujarat, India - (and 17 more...)
|
|
| 58 |
NCT01667094 |
Active, not recruiting |
A Study Comparing Continuous Infusion Antibiotics to Standard Treatment for Lung Infections in Cystic Fibrosis |
|
- Drug: Intermittent, short infusion Ceftazidime
- Drug: Continuous infusion Ceftazidime
- Drug: Intermittent, short infusion Meropenem
- (and 7 more...)
|
Interventional
|
Phase 4 |
|
Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Cystic Fibrosis Questionnaire-Revised respiratory component (CFQ-R) respiratory symptom score
- Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R) respiratory symptom score
- Lung function testing; Forced volume expired in one second (FEV1)
- (and 5 more...)
|
50 |
All |
18 Years and older (Adult, Older Adult) |
NCT01667094 |
249/12
U1111-1132-8291 |
CISTIC |
September 2012 |
July 2017 |
July 2017 |
August 17, 2012 |
April 20, 2017 |
|
- The Alfred Hospital
Melbourne, Victoria, Australia
|
|
| 59 |
NCT03147807 |
Recruiting |
BetaLACTA® Test for Early De-escalation of Empirical Carbapenems in Pulmonary, Urinary and Bloodstream Infections in ICU |
- Pneumonia
- Urinary Tract Infections
- Bloodstream Infection
|
- Device: betaLACTA® rapid diagnostic test
|
Interventional
|
Not Applicable |
- Assistance Publique - Hôpitaux de Paris
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- mortality at D90 and infection recurrence during the ICU stay
- Exposure to carbapenems
- Total use of ICU and hospital resources and cost-effectiveness of early de-escalation compared to standard de-escalation.
- (and 5 more...)
|
646 |
All |
18 Years and older (Adult, Older Adult) |
NCT03147807 |
P 150940
N° IDRCB 2016-A00941-50 |
BLUE-CarbA |
October 20, 2017 |
November 20, 2019 |
January 20, 2020 |
May 10, 2017 |
February 27, 2018 |
|
- Anesthesiology and Critical Care Medicine Department
Paris, France
|
|
| 60 |
NCT03776409 |
Recruiting |
Safety and Efficacy of Vancomycin Plus Beta-lactams |
|
- Drug: vancomycin plus piperacillin/tazobactam
- Drug: vancomycin plus other beta-lactams
|
Observational
|
|
- First Affiliated Hospital Xi'an Jiaotong University
- Second Affiliated Hospital Xi'an Jiaotong University
|
Other |
- Observational Model: Cohort
- Time Perspective: Retrospective
|
- AKI(acute kidney injury)
- clinical efficacy
- the length of hospital stay
- (and 5 more...)
|
1458 |
All |
18 Years and older (Adult, Older Adult) |
NCT03776409 |
XJTU1AF2018LSK-169 |
SEVPB |
December 12, 2018 |
December 1, 2019 |
December 1, 2019 |
December 14, 2018 |
December 27, 2018 |
|
- First Affiliated Hospital of Xian Jiaotong University
Xi'an, Shaanxi, China
|
|
| 61 |
NCT02795949 |
Recruiting |
Study on Reduced Antibiotic Treatment vs Broad Spectrum Betalactam in Patients With Bacteremia by Enterobacteriaceae |
- Enterobacteriaceae Infections
|
- Drug: Antipseudomonal beta-lactam antibiotic
- Drug: De-escalation(short-spectrum antibiotic)
|
Interventional
|
Phase 3 |
- Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
- Spanish Network for Research in Infectious Diseases
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Clinical cure at day 3-5 after treatment.
- Early clinical and microbiological response.
- Late clinical and microbiological response.
- (and 7 more...)
|
344 |
All |
18 Years to 90 Years (Adult, Older Adult) |
NCT02795949 |
SIMPLFY |
SIMPLIFY |
October 2016 |
January 2020 |
February 2020 |
June 10, 2016 |
May 14, 2018 |
|
- Jerez de la Frontera Hospital
Jerez de la Frontera, Cádiz, Spain - La Línea de La Concepción Hospital
La Línea de La Concepción, Cádiz, Spain - University Hospital Donostia
San Sebastian, Gipúzcoa, Spain - (and 18 more...)
|
|
| 62 |
NCT03790631 |
Not yet recruiting |
The OPTIMAL TDM Study: Determining Optimal Beta-lactam Plasma Concentrations Through Therapeutic Drug Monitoring |
- Beta-lactam Antibiotics
- Therapeutic Drug Monitoring
- Toxicity
- (and 8 more...)
|
- Other: The study is observational.
|
Observational
|
|
- University of Geneva, Switzerland
- University Hospital, Geneva
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Incidence of clinical toxicity through day 30 after start of study antibiotic
- Clinical response: incidence of clinical cure
- clinical response in patients with neutropenic fever: incidence of clinical cure in this subpopulation
- (and 11 more...)
|
700 |
All |
18 Years and older (Adult, Older Adult) |
NCT03790631 |
2018-01830 |
OPTIMAL TDM |
January 14, 2019 |
December 31, 2020 |
January 31, 2021 |
December 31, 2018 |
December 31, 2018 |
|
- Geneva University Hospitals
Geneva, Switzerland
|
|
| 63 |
NCT00418470 |
Terminated |
Prolonging the Duration of Peripheral Venous Catheters in Cystic Fibrosis People |
|
- Procedure: regular dilution of antibiotic in NS
- Procedure: higher dilution of antibiotic in NS
|
Interventional
|
Phase 4 |
- University of Florence
- Italian Cystic Fibrosis Research Foundation
- Ospedale Meyer
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- The irritation level of the first vein that is cannulated for the course assessed each day. The assessment will be done utilizing the "Phlebitis Scale" of the Standard of Practice of the Intravenous Nurses Society (Journal of Intravenous Nursing 2000;
- The number of days that the first short peripheral venous catheter used for the treatment course stays in situ before removal
|
60 |
All |
18 Years and older (Adult, Older Adult) |
NCT00418470 |
FFC #19/2006 |
|
March 2007 |
August 2011 |
August 2011 |
January 4, 2007 |
October 29, 2015 |
|
- Meyer Pediatric Hospital (Ospedale Pediatrico Meyer)
Florence, Italy
|
|
| 64 |
NCT01587768 |
Completed |
WEUKBRE5555: IMI PROTECT(Work Package 2): Liver Injury & Antibiotics |
|
- Drug: Antibiotic prescription during the study period between January 1, 2004 and December 31, 2009
|
Observational
|
|
|
Industry |
- Time Perspective: Retrospective
|
- Idiopathic acute liver injury
|
1 |
All |
Child, Adult, Older Adult |
NCT01587768 |
115738
WEUKBRE5559 |
|
November 2011 |
July 2014 |
July 2014 |
April 30, 2012 |
December 10, 2014 |
|
|
|
| 65 |
NCT02099240 |
Recruiting |
Patients Response to Early Switch To Oral:Osteomyelitis Study |
|
- Drug: oral antibiotics
- Procedure: intravenous antibiotics
|
Interventional
|
Early Phase 1 |
- Julio Ramirez
- University of Louisville
|
Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Clinical Failures
- Evaluation of adverse events related to the use of antibiotics
- Cost of care from the hospital perspective
|
456 |
All |
18 Years to 100 Years (Adult, Older Adult) |
NCT02099240 |
14.0185 |
PRESTO:Osteo |
April 2014 |
September 2019 |
September 2019 |
March 28, 2014 |
March 8, 2018 |
|
- University of Louisville
Louisville, Kentucky, United States
|
|
| 66 |
NCT02088970 |
Terminated |
Safety and Efficacity of Corneal Collagen Crosslinking in Infectious Keratitis (Bacterial and Fungal ): Randomized,Controlled, Prospective Study. (CXL) |
- Bacterial Keratitis
- Fungal Keratitis
|
- Device: Crosslinking
- Drug: antibiotic treatment
|
Interventional
|
Not Applicable |
- Nantes University Hospital
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Duration of corneal complete epithelial healing in days.
- Size of the corneal scar
- Corneal thinning
- Gain of visual acuity
|
21 |
All |
18 Years and older (Adult, Older Adult) |
NCT02088970 |
RC14_0004 |
CXL |
September 2014 |
April 2017 |
April 2017 |
March 17, 2014 |
June 1, 2017 |
|
|
|
| 67 |
NCT00435305 |
Terminated |
Steady State Serum and Epithelial Lining Fluid (ELF) Antibiotics Concentrations Under Continous Infusion |
|
- Drug: Meropenem
- Drug: Vancomycin
- Drug: Linezolid
- (and 3 more...)
|
Observational
|
|
- University Hospital Tuebingen
|
Other |
- Time Perspective: Prospective
|
|
40 |
All |
18 Years and older (Adult, Older Adult) |
NCT00435305 |
2005-002128-32 |
|
November 2006 |
|
November 2007 |
February 14, 2007 |
June 9, 2008 |
|
- Universitäsklinikum Tübingen, Klinik für Anästhesiologie und Intensivmedizin
Tübingen, Germany
|
|
| 68 |
NCT01543334 |
Completed |
Antibiotic Concentrations Among Critically Ill Patients |
- Administration of Antibiotics in Intensive Care Units
|
- Biological: Blood sampling
|
Observational
|
|
- Centre Hospitalier Universitaire de Nīmes
|
Other |
- Observational Model: Case-Only
- Time Perspective: Cross-Sectional
|
- [antibiotics] in blood versus bactericidal activity
- Apache II score
- SOFA score
- (and 4 more...)
|
98 |
All |
18 Years and older (Adult, Older Adult) |
NCT01543334 |
LOCAL/2011/JYL-03
2011-A01339-32 |
DALI |
March 2012 |
March 2012 |
March 2012 |
March 2, 2012 |
March 26, 2015 |
|
- CH du Pays d'Aix
Aix en Provence, France - CHU d'Amiens - Hôpital Nord
Amiens Cedex 1, France - CHU d'Angers - Hôtel-Dieu
Angers, France - (and 10 more...)
|
|
| 69 |
NCT00035425 |
Completed |
Treatment of Neutropenic Patients With Fever Who Are Suspected to Have A Gram Positive Infection |
|
- Drug: linezolid
- Drug: vancomycin
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Clinical efficacy of linezolid when administered intravenously as compared to intravenously administered vancomycin in the empiric treatment of oncology patients with febrile neutropenia with suspected gram-positive infections.
- Microbiologic outcome
- Pathogen eradication (eradication rates of individual pathogens)
- (and 5 more...)
|
120 |
All |
13 Years and older (Child, Adult, Older Adult) |
NCT00035425 |
M12600079
A5951059 |
|
November 2001 |
|
November 2002 |
May 6, 2002 |
December 1, 2009 |
|
- Pfizer Investigational Site
Los Angeles, California, United States - Pfizer Investigational Site
Springfield, Illinois, United States - Pfizer Investigational Site
Springfield, Illinois, United States - (and 37 more...)
|
|
| 70 |
NCT02894684 |
Active, not recruiting |
Aztreonam for Inhalation Solution (AZLI) for the Treatment of Exacerbations of Cystic Fibrosis |
- Cystic Fibrosis
- Infection
- Pseudomonas
|
- Drug: Aztreonam
- Drug: Standard Care
|
Interventional
|
Phase 4 |
- Liverpool Heart and Chest Hospital NHS Foundation Trust
- University of Liverpool
|
Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Average actual change in percent predicted forced expiratory volume at 1 second (FEV1) from Day 1 to Day 28
- Time to first pulmonary exacerbation
- Average change from baseline in the Cystic Fibrosis Quality of Life Questionnaire (CFQ-R)
- (and 3 more...)
|
16 |
Male |
16 Years to 65 Years (Child, Adult, Older Adult) |
NCT02894684 |
2016AZLIND001 |
AZTEC-CF |
November 2016 |
February 2019 |
July 2019 |
September 9, 2016 |
August 21, 2018 |
|
- Liverpool Heart & Chest Hospital NHS Trust
Liverpool, United Kingdom
|
|
| 71 |
NCT00153634 |
Completed |
Standard vs. Biofilm Susceptibility Testing in Cystic Fibrosis (CF) |
- Cystic Fibrosis
- Chronic Bronchitis
|
- Drug: IV amikacin
- Drug: PO azithromycin
- Drug: IV ceftazidime
- (and 5 more...)
|
Interventional
|
Not Applicable |
- Seattle Children's Hospital
- Cystic Fibrosis Foundation
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Microbiological efficacy: Change in P. aeruginosa density
- Clinical efficacy: Pre- to post-treatment change in FEV1
- Safety: Adverse events, including new onset of acute pulmonary exacerbation and/or the need to change antibiotic therapy during the treatment period
- Feasibility: Average costs and time per assay; rate of patient withdrawal because resistance patterns preclude randomization; self-reported technician satisfaction
|
75 |
All |
14 Years and older (Child, Adult, Older Adult) |
NCT00153634 |
BURNS03A0 |
|
March 2004 |
|
November 2007 |
September 12, 2005 |
March 13, 2008 |
|
- University of Iowa
Iowa City, Iowa, United States - Washington University St. Louis
St. Louis, Missouri, United States - University of Cincinnati
Cincinnati, Ohio, United States - (and 5 more...)
|
|
| 72 |
NCT00707239 |
Terminated
Has Results |
Study Evaluating Safety and Efficacy of Tigecycline Versus Imipenem/Cilastatin Subjects With Hospital-Acquired Pneumonia |
|
- Drug: tigecycline
- Drug: imipenem/cilastatin
|
Interventional
|
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Percentage of Participants With Clinical Response in Clinically Evaluable (CE) Population at Test-of-Cure (TOC) Visit
- Percentage of Participants With Clinical Response in Clinical Modified Intent-to-treat (c-mITT) Population at Test-of-Cure (TOC) Visit
- Percentage of Participants With Clinical Response in Ventilator Associated Pneumonia (VAP) and Non-VAP Participants at Test-of-Cure (TOC) Visit
- (and 2 more...)
|
108 |
All |
18 Years and older (Adult, Older Adult) |
NCT00707239 |
3074K6-2000
B1811004 |
|
December 2008 |
June 2011 |
June 2011 |
June 30, 2008 |
July 10, 2012 |
July 10, 2012 |
- Pfizer Investigational Site
Louisville, Kentucky, United States - Pfizer Investigational Site
Omaha, Nebraska, United States - Pfizer Investigational Site
Morgantown, West Virginia, United States - (and 37 more...)
|
|
| 73 |
NCT01431326 |
Recruiting |
Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care |
- Adenovirus
- Anesthesia
- Anxiety
- (and 47 more...)
|
- Drug: The POPS study is collecting PK data on children prescribed the following drugs of interest per standard of care:
|
Observational
|
|
- Daniel Benjamin
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- The EMMES Corporation
- Duke University
|
Other / NIH / Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Composite of pharmacokinetic outcomes for understudied drugs in children
- Composite pharmacodynamic outcomes of understudied drugs in children
- Biomarkers associated with understudied drugs in children
|
10000 |
All |
up to 21 Years (Child, Adult) |
NCT01431326 |
Pro00029638
IND 113645
IND 114369
IND 114531
IND 118358
HHSN20100006
HHSN27500020
HHSN27500027
HHSN27500043
HHSN27500049 |
PTN_POPS |
November 2011 |
February 2020 |
February 2020 |
September 9, 2011 |
April 4, 2018 |
|
- Alaska Native Medical Center
Anchorage, Alaska, United States - Arkansas Children's Hospital
Little Rock, Arkansas, United States - University of California at San Diego Medical Center
La Jolla, California, United States - (and 51 more...)
|
|
| 74 |
NCT03113344 |
Recruiting |
Population Pharmacokinetics of Anti-infective Drugs in Children With Infectious Diseases |
|
- Drug: cephalosporins,penicillins,macrolides,carbapenems and antiviral drugs
|
Observational
|
|
- Beijing Children's Hospital
- Shandong University
- Robert Debré Hospital
- Rennes University Hospital
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- maximum concentration (Cmax)
- time to achieve maximum concentration (Tmax)
- absorption rate constant (ka)
- (and 2 more...)
|
800 |
All |
up to 18 Years (Child, Adult) |
NCT03113344 |
BCH_PPK002
Yu-Jie Qi
Wei Zhao
Hui Qi
Fei Jin
Evelyne Jacqz-Aigrain
Stephanie Leroux |
|
June 21, 2017 |
October 1, 2025 |
December 31, 2025 |
April 13, 2017 |
December 19, 2017 |
|
- Beijing Children's Hospital of Capital Medical University
Beijing, China
|
|
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