| 1 |
NCT02688790 |
Recruiting |
Study Evaluate the PK Profile of Dalbavancin in Hospitalized Infants and Neonates Patients With Known or Suspected Bacterial Infection |
|
|
Interventional |
Phase 1 |
- Durata Therapeutics Inc., an affiliate of Allergan plc
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Basic Science
|
- Plasma concentration of dalbavancin
- Number of patients experiencing a treatment emergent adverse event
- Maximum plasma drug concentration (Cmax)
- (and 4 more...)
|
12 |
All |
up to 28 Days (Child) |
NCT02688790 |
DAL-PK-02 |
|
April 1, 2016 |
May 1, 2020 |
May 1, 2020 |
February 23, 2016 |
July 6, 2017 |
|
- University of Arkansas Medical Center
Little Rock, Alaska, United States - University of California, San Diego
San Diego, California, United States - Connecticut Children's Medical Center
Hartford, Connecticut, United States - (and 2 more...)
|
| 2 |
NCT02794831 |
Not yet recruiting |
Exposure to NSAIDs (Non Steroidal Anti-Inflammatory Drugs) and Severity of Community-acquired Bacterial Infections |
|
|
Observational |
|
- Nantes University Hospital
- University Hospital, Tours
- University Hospital, Grenoble
- (and 4 more...)
|
Other |
- Observational Model: Case Control
- Time Perspective: Prospective
|
- exposure to NSAIDs
- Name of NSAIDS
- type of bacterial infection at risk of worsening when exposed to NSAIDs
- (and 3 more...)
|
300 |
All |
18 Years and older (Adult, Senior) |
NCT02794831 |
RC15_0364 |
ANAIG |
June 2016 |
June 2019 |
June 2019 |
June 9, 2016 |
June 9, 2016 |
|
|
| 3 |
NCT02687906 |
Recruiting |
Dose-finding, Pharmacokinetics, Safety, and Tolerability of VABOMERE (Meropenem-Vaborbactam) in Pediatric Subjects With Serious Bacterial Infections |
|
|
Interventional |
Phase 1 |
- Melinta Therapeutics, Inc.
- Department of Health and Human Services
|
Industry / U.S. Fed |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Pharmacokinetics: AUC0-∞
- Pharmacokinetics: Cmax
- Pharmacokinetics: time to maximum plasma concentration (Tmax)
- (and 8 more...)
|
60 |
All |
up to 17 Years (Child) |
NCT02687906 |
Rempex 507 |
TANGOKIDS |
July 2016 |
August 2019 |
September 2019 |
February 22, 2016 |
March 22, 2018 |
|
- Arkansas Children's Hospital
Little Rock, Arkansas, United States - Children's Hospital of Orange County
Orange, California, United States - Rady Children's Hospital San Diego
San Diego, California, United States - (and 4 more...)
|
| 4 |
NCT02134301 |
Recruiting |
Open-Label, Dose-Finding, Pharmacokinetics, Safety and Tolerability Study of Oritavancin in Pediatric Patients With Suspected or Confirmed Bacterial Infections |
- Gram Positive Bacterial Infections
|
|
Interventional |
Phase 1 |
- Melinta Therapeutics, Inc.
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Pharmacokinetics
- Safety Endpoint
|
52 |
All |
up to 18 Years (Child, Adult) |
NCT02134301 |
TMC-ORI-11-01 |
|
May 2014 |
December 2018 |
June 2019 |
May 9, 2014 |
March 12, 2018 |
|
- Arkansas Children's Hospital
Little Rock, Arkansas, United States - CHOC Children's
Orange, California, United States - Rady Children's Hospital San Diego
San Diego, California, United States - (and 6 more...)
|
| 5 |
NCT03225079 |
Recruiting |
PERFORM = Pentaglobin® Registry For Outcome Report and Monitoring |
- Severe Bacterial Infection
|
|
Observational |
|
|
Other |
- Observational Model: Other
- Time Perspective: Other
|
- APACHE II and SAPS II predicted mortality vs. observed hospital mortality and
- difference in SOFA scores, baseline vs. posttreatment (24 hours after last application) assessment
- In-hospital mortality total and in subgroups according to baseline IgM serum levels and baseline CRP
- (and 5 more...)
|
400 |
All |
18 Years and older (Adult, Senior) |
NCT03225079 |
ZKSJ0103_PERFORM |
PERFORM |
November 8, 2017 |
June 2020 |
June 2021 |
July 21, 2017 |
November 30, 2017 |
|
- Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany
|
| 6 |
NCT02760745 |
Recruiting |
Fever and Shivering: Frequency and Role in Predicting Serious Bacterial Infection |
- Febrile Shivering
- Severe Bacterial Infection
|
|
Observational |
|
- Assaf-Harofeh Medical Center
|
Other |
- Observational Model: Case Control
- Time Perspective: Prospective
|
- Proportion of febrile children who experienced shivering
- Severe bacterial infection
- High inflammatory markers
- (and 2 more...)
|
200 |
All |
3 Months to 18 Years (Child, Adult) |
NCT02760745 |
ASF-0207-15 |
|
January 2016 |
November 2016 |
December 2016 |
May 4, 2016 |
November 15, 2016 |
|
- Assaf Harofeh MC
Zerifin, Israel
|
| 7 |
NCT02750761 |
Recruiting |
A Study of Oral and Intravenous (IV) Tedizolid Phosphate in Hospitalized Participants, Ages 2 to <12 Years, With Confirmed or Suspected Bacterial Infection (MK-1986-013) |
- Gram-Positive Bacterial Infections
|
- Drug: Tedizolid Phosphate (IV)
- Drug: Tedizolid Phosphate (oral suspension)
|
Interventional |
Phase 1 |
- Merck Sharp & Dohme Corp.
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Maximum observed drug concentration in plasma (Cmax) of tedizolid phosphate
- Time to reach peak plasma concentration (tmax) of tedizolid phosphate
- Area under the plasma concentration-time curve (AUC) of tedizolid phosphate
- (and 4 more...)
|
32 |
All |
2 Years to 11 Years (Child) |
NCT02750761 |
1986-013
TR701-120
2015-004595-29 |
|
May 2, 2016 |
March 23, 2019 |
March 23, 2019 |
April 25, 2016 |
April 18, 2018 |
|
- Call for Information (Investigational Site 0124)
Little Rock, Arkansas, United States - Call for Information (Investigational Site 0109)
Los Angeles, California, United States - Call for Information (Investigational Site 0101)
Orange, California, United States - (and 14 more...)
|
| 8 |
NCT03397433 |
Recruiting |
ANti-infective Stewardship Using the Wisca Tool in the Electronic Medical Record |
|
- Other: Information Technology physician assist
|
Interventional |
Not Applicable |
- NorthShore University HealthSystem Research Institute
|
Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Changes in length of stay
- Rapid response to initial therapy
- Reduced cost of ancillary testing
- (and 7 more...)
|
6000 |
All |
18 Years and older (Adult, Senior) |
NCT03397433 |
EH13-368 |
ANSWER |
June 2015 |
July 2018 |
October 2018 |
January 12, 2018 |
January 12, 2018 |
|
- NorthShore University HealthSystem Research Institute
Evanston, Illinois, United States
|
| 9 |
NCT03204591 |
Not yet recruiting |
Bacterial Infections in Cirrhotic Patients With Acute Severe Liver Injury |
- Cirrhosis, Liver
- Bacterial Infections
- Acute Liver Injury
|
|
Observational |
|
- The Zhejiang Study Group for Organ Failure in Cirrhosis
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Occurrence of bacterial infection
- 28-day Mortality
- 90-day Mortality
|
500 |
All |
Child, Adult, Senior |
NCT03204591 |
NSFC81670567 |
|
July 20, 2017 |
October 18, 2018 |
January 18, 2019 |
July 2, 2017 |
July 2, 2017 |
|
|
| 10 |
NCT03369951 |
Recruiting |
Minocycline PK (ACUMIN) |
|
|
Interventional |
Phase 4 |
- National Institute of Allergy and Infectious Diseases (NIAID)
|
NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Calculated exposure measures for area under the curve 0 to 24 hours after a dose (AUC0-24)
- Calculated exposure measures for area under the curve from 0 to infinity (AUC0-inf) using free-drug concentrations
- Calculated exposure measures for area under the curve from 0 to infinity (AUC0-inf) using total-drug concentrations
- (and 19 more...)
|
67 |
All |
18 Years to 99 Years (Adult, Senior) |
NCT03369951 |
16-0011
5UM1AI104681-06 |
|
February 7, 2018 |
January 31, 2019 |
January 31, 2019 |
December 12, 2017 |
March 30, 2018 |
|
- DeKalb Medical Hospital - Clinical Trials - Immunology/Infectious Disease
Decatur, Georgia, United States - Northwestern Memorial Hospital - ICU
Chicago, Illinois, United States - University of Kentucky - UK Albert B Chandler Hospital
Lexington, Kentucky, United States - (and 10 more...)
|
| 11 |
NCT03475472 |
Recruiting
New |
Direct Molecular Characterization of Bacteria From ICU |
|
|
Observational |
|
- University Hospital, Basel, Switzerland
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Abundance of pathogen proteins
|
1560 |
All |
Child, Adult, Senior |
NCT03475472 |
2018-00049 |
me17Khanna2 |
February 1, 2018 |
January 31, 2020 |
January 31, 2021 |
March 23, 2018 |
March 23, 2018 |
|
- Division of Infectious Diseas and Hospital Epidemiology
Basel, Switzerland
|
| 12 |
NCT03450187 |
Recruiting |
A Phase 1 TP-271 Oral PK Multiple Ascending Dose Study |
|
|
Interventional |
Phase 1 |
- Tetraphase Pharmaceuticals, Inc.
- National Institute of Allergy and Infectious Diseases (NIAID)
|
Industry / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Other
|
- Adverse Events
- A Directed Physical Examination including chest/respiratory
- A Directed Physical Examination including heart/cardiovascular
- (and 26 more...)
|
40 |
All |
18 Years to 50 Years (Adult) |
NCT03450187 |
TP-271-004 |
|
March 20, 2018 |
August 2018 |
January 2019 |
March 1, 2018 |
April 6, 2018 |
|
- PPD Phase I Clinic
Austin, Texas, United States
|
| 13 |
NCT03424525 |
Recruiting |
11C-Trimethoprim PET/CT Imaging to Evaluate Biodistribution and Kinetics in Human Subjects |
|
|
Interventional |
Phase 1 |
- University of Pennsylvania
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Basic Science
|
- Kinetics of uptake of [11C]TMP in human patients
- [11C]trimethoprim in infected versus non-infected tissues
- The change in biodistribution which includes kinetics of uptake of [11C]TMP in human patients after therapy
|
30 |
All |
18 Years and older (Adult, Senior) |
NCT03424525 |
827333 |
|
February 1, 2018 |
November 2019 |
November 2019 |
February 7, 2018 |
April 11, 2018 |
|
- Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
|
| 14 |
NCT02837081 |
Recruiting |
Preauthorization Versus Prospective Audit in Antimicrobial Stewardship Program |
|
- Other: Prospective audit strategy of antimicrobial stewardship
- Other: preauthorization strategy of antimicrobial stewardship
|
Interventional |
Not Applicable |
- Kaohsiung Veterans General Hospital.
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
|
- Antimicrobial utilization using defined daily dose (DDD)
- Antimicrobial utilization using defined daily dose per 1000 patient days (DID)
- Appropriateness of antimicrobial prescription by susceptibility of culture
- Rate of acceptance to use antimicrobial agents recommended by infectious disease physicians
|
1060 |
All |
20 Years and older (Adult, Senior) |
NCT02837081 |
VGHKS15-CT12-05 |
|
December 2015 |
December 2016 |
March 2017 |
July 19, 2016 |
July 19, 2016 |
|
- Kaohsiung Veterans General Hospital
Kaohsiung, Taiwan
|
| 15 |
NCT02598141 |
Recruiting |
Grinding Versus Standard Methods for the Treatment of Per-operative Bacteriological Samples Associated With Osteo-articular Sepsis |
|
- Biological: Biological sampling grinding
- Biological: Biological sampling with standard procedures
|
Interventional |
Not Applicable |
- Centre Hospitalier Universitaire de Nīmes
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- Presence/absence of an osteo-articular infection according to sample that underwent Ultra Turrax® grinding
- Presence/absence of an osteo-articular infection according to sample that underwent standard treatment
- Identification of bacterial species
|
122 |
All |
18 Years and older (Adult, Senior) |
NCT02598141 |
LOCAL/2015/NC-01
2015-A00720-49 |
IOAP Turrax |
May 2016 |
November 2017 |
November 2017 |
November 5, 2015 |
May 24, 2016 |
|
- CHRU de Nîmes - Hôpital Universitaire Carémeau
Nîmes Cedex 09, France
|
| 16 |
NCT02436876 |
Recruiting |
Study to Assess Safety and Clinical Activity of Local MBN-101 in Treatment of Infected Bone Sites |
|
- Drug: MBN-101
- Other: Placebo
|
Interventional |
Phase 2 |
- Microbion Corporation
- University of Pennsylvania
- University of California, San Francisco
- (and 2 more...)
|
Industry / Other / U.S. Fed |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Participant)
- Primary Purpose: Treatment
|
- Number of Participants with Changes in Clinical Laboratory Tests, Vital Signs, Physical Exams, Electrocardiograms, Microbiology Status, Treatment Failures and/or Adverse Events as a composite to measure Safety and Tolerability
- Number of Serious Interventions Required Post-Treatment to Eradicate Infection
- Time to First Serious Intervention
- (and 2 more...)
|
24 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT02436876 |
MBN-101-201
W81XWH-12-2-0100 |
|
January 2016 |
June 2018 |
July 2018 |
May 7, 2015 |
November 13, 2017 |
|
- Orthopedic Trauma Institute, University of California San Francisco
San Francisco, California, United States - UCSF - Parnassus
San Francisco, California, United States - LifeBridge Health, Inc.
Baltimore, Maryland, United States - (and 3 more...)
|
| 17 |
NCT02527681 |
Recruiting |
Pharmacokinetics and Safety of Ceftobiprole in Neonates and Infants up to 3 Months Treated With Systemic Antibiotics |
|
|
Interventional |
Phase 1 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Observed maximum plasma concentration (Cmax) of ceftobiprole
- Apparent terminal elimination half-life (t½) of ceftobiprole
- Area under the plasma concentration-time curve from time zero to infinity and to last observation (AUC0-inf; AUC0-t) of ceftobiprole
- (and 6 more...)
|
45 |
All |
up to 3 Months (Child) |
NCT02527681 |
BPR-PIP-001
2013-004614-18 |
|
November 2016 |
December 2018 |
December 2018 |
August 19, 2015 |
January 31, 2018 |
|
- AZ Sint-Jan Brugge-Oostende AV
Brugge, Belgium - UZ Leuven
Leuven, Belgium - Klinikum der Universität München
Munich, Germany - (and 2 more...)
|
| 18 |
NCT01611740 |
Recruiting |
Contribution of Real Time Analyses of CARdio-RESpiratory Signals to the Diagnosis of Infection in PREterM Infants |
|
- Procedure: Analysis of the heart rate and respiratory characteristics / Telemonitoring system prototype developed by INSERM U-642
|
Observational |
|
- Rennes University Hospital
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Diagnosis of proven or suspected bacterial infection
- Inflammation without proven or suspected bacterial infection defined as follows: a 6 hours period with CRP> 5 mg/L not classified as proven or suspected bacterial infection.
- Periods of discomfort defined as at least two EDIN scores above 3 in a 6 hours period
|
500 |
All |
24 Weeks to 32 Weeks (Child) |
NCT01611740 |
2011-A00324-37 |
CARESS_PREMI |
May 2012 |
November 2017 |
January 2018 |
June 5, 2012 |
August 29, 2017 |
|
- CHU Angers
Angers, Maine et Loire, France - CHU de Lille
Lille, France - CHU de Rennes
Rennes, France
|
| 19 |
NCT03266341 |
Not yet recruiting |
Detection of Anaerobes in Different Clinicalsamples |
- Anaerobic Bacterial Infection
|
- Diagnostic Test: Cultures
|
Observational |
|
|
Other |
- Observational Model: Case-Only
- Time Perspective: Prospective
|
- Detection of anaerobes in different clinical samples
|
100 |
All |
Child, Adult, Senior |
NCT03266341 |
Anaerobes detection in samples |
|
September 15, 2017 |
November 2019 |
December 2019 |
August 30, 2017 |
September 1, 2017 |
|
|
| 20 |
NCT03299894 |
Recruiting |
Impact of qSOFA Calculation on the Timing of Antimicrobial Therapy in the Emergency Department |
- Bacterial Infection
- Intensive Care
|
- Procedure: systematic calculation of qSOFA
|
Interventional |
Not Applicable |
- Centre Hospitalier Régional d'Orléans
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Sequential Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- Proportion of patients who receive a first dose of antimicrobial agent
- Proportion of patients who receive a first dose of adequate antimicrobial agent
- Proportion of patients with a decrease in SOFA score value ≥ 1 point
- (and 4 more...)
|
780 |
All |
18 Years to 105 Years (Adult, Senior) |
NCT03299894 |
CHRO 2017-06 |
qSOFAST |
November 29, 2017 |
March 29, 2019 |
March 29, 2019 |
October 3, 2017 |
December 4, 2017 |
|
- Regional Hospital center of Orleans
Orléans, France
|
| 21 |
NCT03016845 |
Recruiting |
Pharmacokinetics of Ciprofloxacin in Critically Ill Patients |
|
|
Observational |
|
- Radboud University
- Canisius-Wilhelmina Hospital
- UMC Utrecht
- (and 2 more...)
|
Other |
- Observational Model: Case-Only
- Time Perspective: Prospective
|
- model for estimation of renal function that most accurately predicts ciprofloxacin clearance
|
40 |
All |
18 Years and older (Adult, Senior) |
NCT03016845 |
UMCN-AFK 16.07 |
CAPOEIRA |
January 1, 2017 |
March 2018 |
April 2018 |
January 11, 2017 |
November 17, 2017 |
|
- Ziekenhuis Gelderse Vallei
Ede, Netherlands - CWZ
Nijmegen, Netherlands - Radboudumc
Nijmegen, Netherlands - UMC Utrecht
Utrecht, Netherlands
|
| 22 |
NCT02993575 |
Recruiting |
Pharmacokinetics of Flucloxacillin Given by Continuous or Intermittent Infusion to ICU Patients |
|
|
Observational |
|
- Radboud University
- Canisius-Wilhelmina Hospital
- Rijnstate Hospital
- (and 3 more...)
|
Other |
- Observational Model: Case-Only
- Time Perspective: Prospective
|
|
30 |
All |
18 Years and older (Adult, Senior) |
NCT02993575 |
UMCN-AKF-16.08 |
FANATIC |
June 1, 2017 |
March 2018 |
April 2018 |
December 15, 2016 |
November 17, 2017 |
|
- Radboud University Medical Center
Nijmegen, Netherlands
|
| 23 |
NCT02753387 |
Recruiting |
Effect of Oral Preparation on Bacterial Colonization of the Pharyngeal Mucosa in Surgery of Head and Neck Cancer |
|
- Drug: Chlorhexidine
- Device: NaCl 0.9 %
|
Interventional |
Phase 3 |
- Rennes University Hospital
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Percentage of patients with pharyngeal mucosa colonization (>=10^2 Colony Forming Unit (CFU)/ml of pathogen germs of the oral flora) at the end of the surgery
- Number of patients with a significant rate of pathogen germs (>=10^2 CFU/ml) at T1
- Type of oral germs
- (and 6 more...)
|
80 |
All |
18 Years and older (Adult, Senior) |
NCT02753387 |
35RC15_8923_ORAL-ISO |
ORAL-ISO |
May 23, 2016 |
November 23, 2018 |
February 23, 2019 |
April 27, 2016 |
April 11, 2018 |
|
- Rennes University Hospital
Rennes, France
|
| 24 |
NCT02962934 |
Not yet recruiting |
An Observational Pharmacokinetic Sudy of Ceftolozane-Tazobactam in Intensive Care Unit in Patients With and Without CRRT |
- Gram-Negative Bacterial Infections
|
- Other: Non CRRT group
- Other: CRRT group
|
Observational |
|
- Royal Brisbane and Women's Hospital
- The University of Queensland
|
Other |
- Observational Model: Case-Only
- Time Perspective: Prospective
|
- Measurement of total and unbound Ceftolozane-tazobactam in critically ill patients not receiving CRRT and in patients receiving CRRT
|
18 |
All |
18 Years and older (Adult, Senior) |
NCT02962934 |
Royal_Brisbane |
CT-PK |
November 2016 |
November 2018 |
December 2018 |
November 15, 2016 |
November 15, 2016 |
|
|
| 25 |
NCT02666274 |
Recruiting |
Feasibility Studies to Inform Novel Proposals to Avert Community-Based Antimicrobial Resistance Spread |
- Gram-Negative Bacterial Infections
|
|
Observational |
|
- Guy's and St Thomas' NHS Foundation Trust
|
Other |
- Observational Model: Case Control
- Time Perspective: Prospective
|
- Transmission of resistant gram negative bacteria from index participants and network participants
- Length of Gut Carriage of resistant gram negative bacteria in index participants
|
45 |
All |
18 Years and older (Adult, Senior) |
NCT02666274 |
RJ115/N354 |
|
December 2015 |
January 2017 |
June 2017 |
January 28, 2016 |
November 28, 2016 |
|
- Guy's and St Thomas' NHS Foundation Trust
London, United Kingdom
|
| 26 |
NCT02117986 |
Recruiting |
Efficacy and Mortality of a Loading Dose of Colistin in Critical Ill Patients |
- Gram Negative Bacterial Infections
|
|
Interventional |
Phase 4 |
- Hospital Barros Luco Trudeau
- Fondo Nacional de Desarrollo Científico y Tecnológico, Chile
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Percentage of patients with clinical response to treatment
- percentage of patients with microbiological response
- mortality
|
200 |
All |
18 Years and older (Adult, Senior) |
NCT02117986 |
SA13I20317 |
|
April 2014 |
December 2018 |
December 2018 |
April 21, 2014 |
March 13, 2018 |
|
- Hospital Barros Luco Trudeau
Santiago, Region Metropolitana, Chile - Hospital de Puerto Montt
Puerto Montt, Chile
|
| 27 |
NCT02013141 |
Recruiting |
Telavancin Pediatric PK Study (Ages >3 Months to 17 Years) |
- Gram-Positive Bacterial Infections
|
|
Interventional |
Phase 4 |
- Theravance Biopharma R & D, Inc.
- Theravance Biopharma Antibiotics, Inc.
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Basic Science
|
- Pharmacokinetics- AUC (area under curve)
- Pharmacokinetics- Cmax
- Pharmacokinetics- Tmax
- (and 3 more...)
|
36 |
All |
3 Months to 17 Years (Child) |
NCT02013141 |
0101 |
|
December 2014 |
September 2020 |
October 2020 |
December 17, 2013 |
April 17, 2018 |
|
- Children's Hospital of Orange County
Orange, California, United States
|
| 28 |
NCT03053258 |
Recruiting |
Diagnostic Breath Analysis for Detection of Ventilator Acquired Pneumonia (VAP) |
|
- Device: Collection of exhaled breath sample
|
Observational |
|
- Landon Pediatric Foundation
|
Other |
- Observational Model: Case-Only
- Time Perspective: Prospective
|
- Diagnostic Breath Analysis
|
50 |
All |
18 Years and older (Adult, Senior) |
NCT03053258 |
Study 177 ZNose |
VAP-VOC |
October 2016 |
October 2018 |
February 2019 |
February 15, 2017 |
April 10, 2018 |
|
- Ventura County Medical Center
Ventura, California, United States
|
| 29 |
NCT02553083 |
Recruiting |
High Dose Dual Therapy (HDDT) for Eradication of Helicobacter Pylori Infection |
- Bacterial Infection Due to Helicobacter Pylori (H. Pylori)
|
- Drug: Nexium 40 mg
- Drug: amoxicillin 1.5 gr
- Drug: doxycycline 200 mg
- (and 3 more...)
|
Interventional |
Phase 4 |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
|
300 |
All |
18 Years to 80 Years (Adult, Senior) |
NCT02553083 |
0380-15-RMC |
HDDT |
October 22, 2015 |
September 2020 |
December 2021 |
September 17, 2015 |
January 31, 2018 |
|
- Rabin Medical Center
Petach Tikva, Israel
|
| 30 |
NCT02898948 |
Recruiting |
Procalcitonin (PCT) as a Diagnostic Marker of Bacterial Infection in the Patients Admitted for Fever and/or Inflammatory Syndrome to the Internal Medicine Department |
- Systemic Inflammatory Response Syndrome
- Fever
|
- Biological: Procalcitonin (PCT) as a diagnostic marker of bacterial infection
|
Observational |
|
- Centre Hospitalier Universitaire, Amiens
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
|
133 |
All |
18 Years and older (Adult, Senior) |
NCT02898948 |
RNI2015-38 Dr Schmidt |
PCT-MI |
February 2016 |
August 2018 |
August 2018 |
September 13, 2016 |
September 13, 2016 |
|
|
| 31 |
NCT03160040 |
Recruiting |
A Retrospective Observational Study to Evaluate the Utilization, Outcomes, and Adverse Events in Participants Treated With Minocin® (Minocycline) for Infections Caused by Gram-negative Bacteria in a Real World Setting |
- Gram-Negative Bacterial Infections
|
|
Observational |
|
- Rempex Pharmaceuticals (a wholly owned subsidiary of The Medicines Company)
|
Industry |
- Observational Model: Case-Only
- Time Perspective: Retrospective
|
- Number Of Participants With Each Gram-negative Bacterial Infection Being Treated With Minocycline IV
- Infection-related Length Of Stay For Infections Being Treated With Minocycline IV
- Number Of Participants With A Microbiologic Response
- (and 4 more...)
|
100 |
All |
18 Years and older (Adult, Senior) |
NCT03160040 |
MDCO-MIN-16-05 |
|
October 11, 2017 |
April 1, 2018 |
April 1, 2018 |
May 19, 2017 |
March 5, 2018 |
|
- Lee Memorial Health System
Fort Myers, Florida, United States - Florida Hospital Orlando
Orlando, Florida, United States - University Medical Center of Southern Nevada
Las Vegas, Nevada, United States - (and 3 more...)
|
| 32 |
NCT00945152 |
Recruiting |
Effects of MRSA Bactericidal Gel To Promote Healing and Eliminate MRSA in cSSTI Vancogel(TM) |
- Bacterial Infections
- Wounds
|
- Drug: Vancomycin 1.25-1.50% in a complex gel formulation trademarked Vancogel(R)
- Drug: Placebo, complex gel formulation without Vancomycin
|
Interventional |
Phase 2 |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Eliminate MRSA infection
- More rapid healing of cSSTI
|
100 |
All |
18 Years and older (Adult, Senior) |
NCT00945152 |
WIRB study # 1111446
None yet, self funding |
Vancogel(R) |
July 2011 |
December 2018 |
December 2018 |
July 23, 2009 |
August 30, 2017 |
|
- Robert S Berman MD / 2141 Alt. A1A South, Suite 450
Jupiter, Florida, United States
|
| 33 |
NCT02164409 |
Recruiting |
Changes Associated With H. Pylori and Gastric Carcinogenesis |
- Bacterial Infection Due to Helicobacter Pylori (H. Pylori)
|
- Procedure: Endoscopy tissue collection
|
Observational |
|
- Weill Medical College of Cornell University
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Differences in tranional profiles of samples
- Examine bacterial content in samples
|
120 |
All |
18 Years and older (Adult, Senior) |
NCT02164409 |
1203012274 |
IIT H pylori |
July 2012 |
December 2018 |
December 2018 |
June 16, 2014 |
December 4, 2017 |
|
- Weill Cornell Medical College
New York, New York, United States
|
| 34 |
NCT02931526 |
Recruiting |
Study of Tigecycline Pharmacokinetics in Patients Undergoing Continuous Renal Replacement Therapy(CRRT) |
- Bacterial Infection
- Critically Ill
|
|
Observational |
|
|
Other |
- Observational Model: Case Control
- Time Perspective: Prospective
|
- Tigecycline Steady State Plasma Concentrations
- Peak Plasma Concentration(Cmax) of Tigecycline in blood
- Trough Plasma Concentration(Cmin) of Tigecycline in blood
- (and 2 more...)
|
20 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT02931526 |
LCYJ1 |
|
August 2016 |
August 2017 |
|
October 13, 2016 |
October 13, 2016 |
|
- Zhujiang Hospital,Southern Medical University
Guangzhou, Guangdong, China
|
| 35 |
NCT02914132 |
Recruiting |
Safety Evaluation of Seraph® 100 to Reduce Bacteremia in Patients on Hemodialysis |
- Bacteremia
- Bacterial Infection
|
- Device: Seraph 100 Filter
|
Interventional |
Not Applicable |
- ExThera Medical Corporation
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Demonstrate safety of the ExThera Medical Seraph® 100 Microbind® Affinity Blood Filter in a hemodialysis circuit assessed by rate of adverse events.
- Reduction of bacteria in blood passed through the Seraph 100 filter.
|
15 |
All |
18 Years to 90 Years (Adult, Senior) |
NCT02914132 |
CP001 |
|
February 2016 |
May 2018 |
July 2018 |
September 26, 2016 |
February 1, 2018 |
|
- Klinikum Braunschweig
Braunschweig, Germany - Universitaetsklinikum-Frankfurt
Frankfurt, Germany - Medizinische Hochschule-Hannover
Hannöver, Germany - Universitatsklinikum Muenster
Muenster, Germany
|
| 36 |
NCT03230916 |
Recruiting |
A Pharmacokinetics Study of MK-7655A in Pediatric Participants With Gram-negative Infections (MK-7655A-020) |
- Suspected or Documented Gram-negative Bacterial Infection
|
|
Interventional |
Phase 1 |
- Merck Sharp & Dohme Corp.
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- REL Plasma Exposure
- REL Maximum Concentration
- REL Clearance
- (and 14 more...)
|
44 |
All |
up to 17 Years (Child) |
NCT03230916 |
7655A-020
2016-004328-43 |
|
November 6, 2017 |
August 13, 2020 |
August 13, 2020 |
July 27, 2017 |
April 18, 2018 |
|
- Arkansas Children's Hospital ( Site 1311)
Little Rock, Arkansas, United States - Children's Hospital of Orange County ( Site 1301)
Orange, California, United States - Rady Children's Hospital-San Diego ( Site 1305)
San Diego, California, United States - (and 20 more...)
|
| 37 |
NCT01338116 |
Recruiting |
Optimal Antibiotic Treatment of Moderate to Severe Bacterial Infections |
- Community-associated Infections
- Health-care Acquired Infections
- Nosocomial Infections
|
- Other: antibiotic treatment of by TREAT/PCR
|
Interventional |
Phase 3 |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Clinical success defined as 30-day survival and clinical stability on day 4
- Appropriate empirical antibiotic treatment
- Survival
- (and 4 more...)
|
600 |
All |
18 Years and older (Adult, Senior) |
NCT01338116 |
6036 |
CDSS |
April 2016 |
January 2018 |
January 2019 |
April 19, 2011 |
April 7, 2016 |
|
- Rabin Medical Center, Beilinson Hospital
Petah Tikvah, Israel
|
| 38 |
NCT03233438 |
Recruiting |
Development of a New Critical Pathway for Treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI) |
- Bacterial Infections
- Acute Bacterial Skin and Skin Structure Infection
|
- Drug: Dalbavancin
- Drug: Usual Care
|
Interventional |
Phase 4 |
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number of Infection-related Total Admitted Hospital Days
- Number of Total Admitted Hospital Days
- Number of Infection-related Major Surgical Interventions that Required Operating Room Time
- (and 12 more...)
|
86 |
All |
18 Years and older (Adult, Senior) |
NCT03233438 |
CMO-US-ID-0528 |
|
July 24, 2017 |
June 30, 2018 |
June 30, 2018 |
July 28, 2017 |
August 23, 2017 |
|
- Weill Cornell Medicine
New York, New York, United States
|
| 39 |
NCT01892358 |
Recruiting |
Preventing Bacterial and Viral Infections Among Injection Drug Users |
|
- Behavioral: SKIN Intervention
- Other: Treatment as Usual
|
Interventional |
Not Applicable |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- bacterial infections
- high-risk behavior
- health service use
|
350 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT01892358 |
DA034957
1210-003 |
|
September 2013 |
January 2019 |
January 2019 |
July 4, 2013 |
April 12, 2018 |
|
- Boston Medical Center
Boston, Massachusetts, United States - Butler Hospital
Providence, Rhode Island, United States
|
| 40 |
NCT02655302 |
Not yet recruiting |
Study of the Involvement of IL-17 / IL-22 Pathway in Bacterial Exacerbations of COPD |
- Pulmonary Disease, Chronic Obstructive
- Bacterial Infections
|
- Other: Sample collecting
- Other: Lung function measure
|
Interventional |
Not Applicable |
- University Hospital, Lille
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Basic Science
|
- Measure cytokines by ELISA
- Compare the delta of IL-17 and IL-22 cytokines between exacerbation and steady-state in the blood.
- Identify IL-17 and IL-22 producing cells in the blood
- (and 20 more...)
|
100 |
All |
40 Years and older (Adult, Senior) |
NCT02655302 |
2013_76
2015-A00190-49 |
COPD1722 |
September 2017 |
December 2022 |
December 2022 |
January 14, 2016 |
June 7, 2017 |
|
- University hospital of Lille
Lille, France - Roubaix hospital
Roubaix, France - Seclin hospital
Seclin, France - Tourcoing hospital
Tourcoing, France
|
| 41 |
NCT02572791 |
Recruiting |
Staph Household Intervention for Eradication (SHINE) |
- Skin and Subcutaneous Tissue Bacterial Infections
- Staphylococcus Aureus
- MRSA - Methicillin Resistant Staphylococcus Aureus Infection
|
- Drug: Chlorhexidine
- Drug: Mupirocin
- Behavioral: Household cleaning
|
Interventional |
Phase 4 |
- Washington University School of Medicine
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Incidence of SSTI
- Prevalence of S. aureus colonization in index patients, household contacts, pet dogs and cats, and household surfaces
- Confirmed S. aureus Infection
- (and 4 more...)
|
207 |
All |
up to 18 Years (Child, Adult) |
NCT02572791 |
3177 60559 |
SHINE |
October 2015 |
January 2020 |
July 2020 |
October 9, 2015 |
March 20, 2018 |
|
- St. Louis Children's Hospital
Saint Louis, Missouri, United States - Washington University School of Medicine
Saint Louis, Missouri, United States
|
| 42 |
NCT03431766 |
Recruiting |
0.2% Chx Gel vs Implant Bacterial Contamination |
- Bone Resorption
- Bacteria Caused Disease
|
- Device: placebo gel
- Device: 0.20% chlorhexidine gel
|
Interventional |
Not Applicable |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Prevention
|
- bone resorption around dental implants on both study groups
- Microbiological quantitative evaluation, bacteria count cfu/ml
|
36 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT03431766 |
2342 |
|
November 17, 2015 |
January 12, 2019 |
June 30, 2019 |
February 13, 2018 |
February 13, 2018 |
|
- G. d'Annunzio University
Chieti, CH, Italy
|
| 43 |
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, Senior) |
NCT03243864 |
866 |
|
March 13, 2017 |
March 21, 2019 |
October 21, 2019 |
August 9, 2017 |
August 9, 2017 |
|
- Temple University Hospital
Philadelphia, Pennsylvania, United States
|
| 44 |
NCT02814916 |
Recruiting |
Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections in Children, Known or Suspected to be Caused by Susceptible Gram-positive Organisms, Including MRSA |
- Methicillin-Resistant Staphylococcus Aureus
- Bacterial Infections
- Staphylococcal Skin Infections
|
- Drug: Dalbavancin single dose
- Drug: Dalbavancin two dose
- Drug: Comparator
|
Interventional |
Phase 3 |
- Durata Therapeutics Inc., an affiliate of Allergan plc
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number of patients with abnormal audiologic assessment
- Change in number of patients with the presence of either Clostridium difficile (CD), vancomycin-resistant enterococci (VRE), or both CD and VRE in bowel flora
- Clinical response
- (and 11 more...)
|
300 |
All |
3 Months to 17 Years (Child) |
NCT02814916 |
DUR001-306
2014-005281-30 |
|
March 30, 2017 |
January 25, 2019 |
January 25, 2019 |
June 28, 2016 |
June 7, 2017 |
|
- University of South Alabama
Mobile, Alabama, United States - Maricopa Integrated Health System
Phoenix, Arizona, United States - Southbay Pharma Research
Buena Park, California, United States - (and 37 more...)
|
| 45 |
NCT03438214 |
Not yet recruiting |
Effect of Intermittent Infusion Versus Continuous Infusion of Vancomycin on Kidney Failure in Critically Ill Patients |
- Gram-Positive Bacterial Infections
- Nephrotoxicity
- Sepsis
|
- Drug: Vancomycin Continuous infusion
- Drug: Vancomycin Intermittent infusion
|
Interventional |
Phase 4 |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Acute renal failure
- Hypersensibility reactions with vancomycin
- Length of ICU stay
- (and 3 more...)
|
222 |
All |
18 Years and older (Adult, Senior) |
NCT03438214 |
81226617.8.1001.0065 |
ETERNITY |
April 28, 2018 |
February 28, 2020 |
December 1, 2022 |
February 19, 2018 |
April 5, 2018 |
|
- Faculty of Medicine University os São Paulo
São Paulo, SP, Brazil
|
| 46 |
NCT03163628 |
Recruiting |
biomArkers to differeNtiate bacTerial From vIral iNfEctions |
- Infection, Bacterial
- Infection Viral
|
- Biological: Diagnostic performances of a combination of biomarkers
|
Interventional |
Not Applicable |
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- Diagnosis of severe bacterial infection (SBI)
- Diagnosis of viral infection
- Unfavorable evolution
|
800 |
All |
up to 36 Months (Child) |
NCT03163628 |
69HCL16_0799 |
ANTOINE |
June 6, 2017 |
June 13, 2019 |
June 13, 2019 |
May 23, 2017 |
July 14, 2017 |
|
- Hospices Civils de Lyon
Bron, France - Hôpital Louis Mourier - APHP
Colombes, France - Hôpital Nord Ouest
Gleizé, France
|
| 47 |
NCT03367897 |
Recruiting |
Bleeding Ulcer and Erosions Study "BLUE Study" |
- Bacterial Infection Due to Helicobacter Pylori (H. Pylori)
- Peptic Ulcer
- Bleeding Ulcer
|
|
Observational |
|
- Ostfold Hospital Trust
- University Hospital, Akershus
|
Other |
- Observational Model: Case-Control
- Time Perspective: Prospective
|
- Risk medication and PPI prophylaxis in peptic ulcer bleeding
- Accurate H. pylori infection rate
- In vitro H. pylori resistance to antibiotics
- Eradication rate for H. pylori after OAM triple therapy
|
600 |
All |
18 Years and older (Adult, Senior) |
NCT03367897 |
1319 |
BLUE |
March 2015 |
December 2017 |
July 2018 |
December 11, 2017 |
December 11, 2017 |
|
- Akershus University Hospital
Oslo, Norway - Ostfold Hospital Trust
Sarpsborg, Østfold, Norway
|
| 48 |
NCT03271580 |
Recruiting |
Biofilm Modified Macrophage Phenotype and Function in Diabetic Wound Healing |
- Wound
- Bacterial Infections
- Diabetes Mellitus
- Infected Ulcer of Skin
|
- Diagnostic Test: Finger prick test for HbA1c measurement
- Procedure: Punch Biopsy
- Other: Vac Sponge Collection
- Other: Ankle Brachial Index
|
Observational |
|
- Sashwati Roy
- Ohio State University
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Assess macrophage phenotype and functional modification due to biofilm infection in diabetic patients
- Characterize difference between wound macrophages and macrophages derived from peripheral blood in diabetic patients
|
28 |
All |
18 Years to 70 Years (Adult, Senior) |
NCT03271580 |
2017H0010 |
|
February 5, 2017 |
February 5, 2018 |
August 1, 2018 |
September 5, 2017 |
September 5, 2017 |
|
- The Ohio State University Hospital East
Columbus, Ohio, United States - Comprehsive Wound Care Centers,The Ohio State University Hospital
Columbus, Ohio, United States - Davis Heart and Lung Research Institute
Columbus, Ohio, United States - Martha Morehouse Medical Plaza
Columbus, Ohio, United States
|
| 49 |
NCT03088111 |
Not yet recruiting |
An Open Label Field Study of Anthim (Obiltoxaximab) in Subjects Exposed to B. Anthracis |
- Infection, Bacterial
- Anthrax
|
- Other: Collection of samples
- Biological: Obiltoxaximab
|
Interventional |
Phase 4 |
- Elusys Therapeutics
- Department of Health and Human Services
- Centers for Disease Control and Prevention
- (and 2 more...)
|
Other / U.S. Fed / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Overall survival in suspected, probable, or confirmed cases of inhalational anthrax at Week 24
- Survival at Day 14 and Day 28
- Duration of survival (to Week 24)
- (and 3 more...)
|
100 |
All |
Child, Adult, Senior |
NCT03088111 |
AH501
HHSO100201100034C |
|
January 1, 2020 |
January 1, 2021 |
January 1, 2021 |
March 23, 2017 |
January 9, 2018 |
|
|
| 50 |
NCT03132246 |
Recruiting |
MICRO Study: Detecting Bacterial Infections Related to Orthopaedic Surgical Implants |
- Open Reduction and Internal Fixation of Extremity Fractures
|
- Diagnostic Test: Blood draw
|
Interventional |
Not Applicable |
|
Other |
- Intervention Model: Single Group Assignment
- Masking: Double (Participant, Care Provider)
- Primary Purpose: Diagnostic
|
- Number of Blood Samples with High Levels of Absorbance via ELISA for Patients with Staphylococcal Infections (Greater than 1.5 ratio compared to Control Human Serum)
- Number of Blood Samples taken 2 weeks, 1 month, 2 months, and 3 months after a Staphylococcus-positive culture that Result in High Absorbance Levels via ELISA (Greater than 1.5 ratio compared to Control Human Serum)
- Number of Blood Samples taken 3 months, 2 months, 1 month, and 2 weeks before a Staphylococcus-positive culture that Result in High Absorbance Levels via ELISA (Greater than 1.5 ratio compared to Control Human Serum)
|
500 |
All |
18 Years and older (Adult, Senior) |
NCT03132246 |
HP-00055743 |
MICRO |
April 2014 |
July 2018 |
July 2018 |
April 27, 2017 |
January 19, 2018 |
|
- University of Maryland, Shock Trauma Center
Baltimore, Maryland, United States
|
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