| 1 |
NCT03559530 |
Recruiting
New |
Acinetobacter Baumannii-related Osteomyelitis: Clinical and Epidemiological Characterization |
|
|
Observational
|
|
- University of Sao Paulo
- Pfizer
|
Other / Industry |
- Observational Model: Case-Only
- Time Perspective: Retrospective
|
- Description of the clinical and epidemiological profile of patients with infection
- A. baumannii susceptibility profile
- Patient outcome according to antimicrobial therapy to A. baumannii
- (and 2 more...)
|
241 |
All |
Child, Adult, Older Adult |
NCT03559530 |
14186 |
|
May 1, 2017 |
December 2018 |
May 2019 |
June 18, 2018 |
June 18, 2018 |
|
- Instituto de Ortopedia e Traumatologia do Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
Sao Paulo, Brazil
|
|
| 2 |
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
|
|
| 3 |
NCT02927678 |
Recruiting |
White Blood Cell SPECT/CT and Diabetic Foot Osteomyelitis |
- Diabetic Foot Osteomyelitis
|
- Other: white blood cell SPECT/CT (Single Photon Emission Computed Tomography/Computed Tomography) imaging
|
Observational
|
|
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Rate of remission of osteomyelitis at one year after the cessation of antibiotic treatment, evaluated by white blood cell SPECT/CT (Single Photon Emission Computed Tomography/Computed Tomography).
- Rate of osteomyelitis remission at one year after a 6 weeks antibiotics duration, evaluated by white blood cell SPECT/CT
- Sensibility ration of White Blood Cell SPECT/CT performed at the end of antibiotic treatment to predict the remission of osteomyelitis at one year.
- (and 3 more...)
|
56 |
All |
18 Years and older (Adult, Older Adult) |
NCT02927678 |
69HCL16_0597 |
|
January 2014 |
December 2016 |
December 2016 |
October 7, 2016 |
October 7, 2016 |
|
- Service d'Endocrinologie-Diabétologie-Maladies de la nutrition, GH Sud, Hospices Civils de Lyon
Pierre-Bénite, France
|
|
| 4 |
NCT03433287 |
Recruiting |
Chronic Recurrent Multifocal Osteomyelitis - a Bacterial Cause? |
- Chronic Recurrent Multifocal Osteomyelitis
|
- Diagnostic Test: 18F-NaF-PET/MRI
|
Interventional
|
Not Applicable |
- Rigshospitalet, Denmark
- Region Sjælland
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- Number of detected CRMO lesions
|
20 |
All |
up to 18 Years (Child, Adult) |
NCT03433287 |
Protokol-49657 |
|
November 1, 2015 |
November 1, 2018 |
March 1, 2019 |
February 14, 2018 |
February 15, 2018 |
|
- Rigshospitalet
Copenhagen, Denmark
|
|
| 5 |
NCT02335905 |
Recruiting |
Ceftaroline for Treatment of Hematogenously Acquired Staphylococcus Aureus Osteomyelitis in Children |
- Hematogenously Acquired Staphylococcus Aureus Osteomyelitis
- Bone Infection
- Osteomyelitis
|
- Drug: Ceftaroline Fosamil
|
Interventional
|
Phase 1
Phase 2 |
- Baylor College of Medicine
- Allergan
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Incidence of treatment emergent adverse events (TEAEs), serious adverse events (SAEs), deaths and discontinuations due to adverse events (AEs)
- Clinical response at the conclusion of IV ceftaroline
- Clinical outcome at the completion of total therapy (IV ceftaroline plus oral antibiotics)
- (and 2 more...)
|
18 |
All |
1 Year to 17 Years (Child) |
NCT02335905 |
H-35130
IIT-USA-000586 |
|
January 2015 |
February 2020 |
February 2020 |
January 12, 2015 |
May 14, 2018 |
|
- Texas Children's Hospital
Houston, Texas, United States
|
|
| 6 |
NCT03012529 |
Recruiting |
Investigation of Rifampin to Reduce Pedal Amputations for Osteomyelitis in Diabetics |
- Osteomyelitis
- Diabetes
- Amputation
|
- Drug: Rifampin
- Drug: Riboflavin Placebo
|
Interventional
|
Phase 4 |
- VA Office of Research and Development
|
U.S. Fed |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Amputation-Free Survival
- Time to Amputation
- New course of antibacterial therapy for ipsilateral foot infection
- (and 8 more...)
|
880 |
All |
18 Years to 89 Years (Adult, Older Adult) |
NCT03012529 |
2001 |
VA INTREPID |
November 21, 2017 |
October 1, 2021 |
July 30, 2022 |
January 6, 2017 |
June 7, 2018 |
|
- Phoenix VA Health Care System, Phoenix, AZ
Phoenix, Arizona, United States - VA Loma Linda Healthcare System, Loma Linda, CA
Loma Linda, California, United States - VA Long Beach Healthcare System, Long Beach, CA
Long Beach, California, United States - (and 25 more...)
|
|
| 7 |
NCT02463500 |
Recruiting |
UT Southwestern Diabetic Foot Ulcers (DFU) and Osteomyelitis (DFO) Recruitment Database, Data and Tissue Repository |
- Diabetic Foot Ulcers
- Osteomyelitis
|
|
Observational
|
|
- University of Texas Southwestern Medical Center
- Parkland Health & Hospital System
|
Other |
- Observational Model: Case-Only
- Time Perspective: Prospective
|
- Wound Healing
- Biomarkers
- Adverse Events
|
1000 |
All |
18 Years to 89 Years (Adult, Older Adult) |
NCT02463500 |
18776 |
DFUDatabase |
January 2015 |
January 2020 |
December 2020 |
June 4, 2015 |
May 5, 2016 |
|
- UT Southwestern Medical Center
Dallas, Texas, United States - UT Southwestern Medical Center at Dallas
Dallas, Texas, United States
|
|
| 8 |
NCT02594878 |
Recruiting |
Chronic Non-bacterial Osteomyelitis Treated With Pamidronate |
- Immune System Disease
- Musculoskeletal Disease
|
- Drug: Pamidronatdinatrium
- Other: Natrium chloride 9mg/ml
|
Interventional
|
Phase 2 |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Wholebody MRI
- CT scan of the anterior chestwall (adults)
- Systemic inflammatory markers
- (and 4 more...)
|
32 |
All |
9 Years to 65 Years (Child, Adult, Older Adult) |
NCT02594878 |
48438 |
CNOPAM |
October 2015 |
May 2018 |
August 2018 |
November 3, 2015 |
November 16, 2016 |
|
- Universityhospital of Aarhus, Denmark
Aarhus, Denmark
|
|
| 9 |
NCT01336803 |
Recruiting |
Differentiation of Bone Sarcomas and Osteomyelitis With Ferumoxytol-Enhanced MRI |
- Bone Cancer
- Chondrosarcoma
- Ewing's Sarcoma
- (and 5 more...)
|
- Drug: Feraheme
- Procedure: MR Scan
|
Interventional
|
Not Applicable |
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Diagnostic
|
- all cause mortality
- Differentiation of bone sarcomas and osteomyelitis with ferumoxytol-enhanced MRI.
|
50 |
All |
8 Years to 40 Years (Child, Adult) |
NCT01336803 |
PEDSBONE0006
SU-04062011-7666 |
|
August 2011 |
December 2018 |
December 2019 |
April 18, 2011 |
January 17, 2018 |
|
- Stanford University School of Medicine
Stanford, California, United States
|
|
| 10 |
NCT03426761 |
Recruiting |
Dalbavancin For The Treatment of Gram Positive Osteoarticular Infections |
- Bone Infection
- Osteomyelitis
- Septic Arthritis
- (and 2 more...)
|
- Drug: Dalbavancin
- Drug: Vancomycin
|
Interventional
|
Phase 4 |
- Infectious Diseases Physicians, Inc.
- Johns Hopkins University
|
Other |
- Allocation: Randomized
- Intervention Model: Sequential Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Clinical response (non-failure) to assigned treatment at day #42
- Sustained Clinical Response at day #90
- Sustained Clinical Response at day #180
- (and 4 more...)
|
50 |
All |
18 Years to 80 Years (Adult, Older Adult) |
NCT03426761 |
IIT-2017-10117 |
|
January 25, 2018 |
July 2020 |
January 2021 |
February 8, 2018 |
February 8, 2018 |
|
- Infectious Diseases Physicians, Inc.
Annandale, Virginia, United States
|
|
| 11 |
NCT02979951 |
Recruiting |
Fosfomycin i.v. for Treatment of Severely Infected Patients |
- Bacterial Infections
- Bone Diseases, Infectious
- Osteomyelitis
- (and 13 more...)
|
|
Observational
|
|
- Infectopharm Arzneimittel GmbH
- INPADS GmbH
- Dr. Oestreich + Partner GmbH
|
Industry / Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Percentage of patients with clinical success as defined as clinical cure or clinical improvement
- Microbiological cure
- Clinical success as defined as clinical cure or clinical improvement
- (and 11 more...)
|
1000 |
All |
18 Years and older (Adult, Older Adult) |
NCT02979951 |
FORTRESS |
FORTRESS |
December 2016 |
June 2020 |
June 2020 |
December 2, 2016 |
May 9, 2018 |
|
- Universitätsmedizin Charité
Berlin, Germany - Vivantes Kliniken Neukölln
Berlin, Germany - Städtisches Klinikum Braunschweig
Braunschweig, Germany - (and 9 more...)
|
|
| 12 |
NCT03009045 |
Recruiting |
Tolerability, Safety, and Efficacy of Tedizolid as Oral Treatment for Bone and Joint Infections |
|
|
Interventional
|
Phase 2 |
- Los Angeles Biomedical Research Institute
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number of "moderate" or "serious" adverse events as assessed by MedDRA v18.1
- Number of participants with an outcome of "cure" as defined as no need for further antibiotics beyond the originally planned duration determined by the participant's primary/treating physician.
- Number of participants with treatment-related adverse events as assessed by MedDRA v18.1
|
55 |
All |
18 Years to 85 Years (Adult, Older Adult) |
NCT03009045 |
21814-01 |
|
February 6, 2017 |
July 2018 |
January 2019 |
January 4, 2017 |
May 15, 2018 |
|
- Harbor-UCLA Medical Center
Torrance, California, United States - Los Angeles BioMedical Research Institute (LA BioMed)
Torrance, California, United States
|
|
| 13 |
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, Older Adult) |
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...)
|
|
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