Clinical trials: Osteomyelitis
Osteomyelitis
Study on the Safety and Efficacy of Dalbavancin Versus Active Comparator in Adult Participants With Osteomyelitis
This clinical study will be a single-center, randomized, open-label, active-controlled, parallel-group study comparing dalbavancin to standard of care (SOC) therapy in osteomyelitis.
- Trial name
- NCT02685033
- Testing
- Dalbavancin, Comparator
- Where
- Ukraine
- Volunteers
- 80 people
- Sponsor
- Durata Therapeutics Inc., an affiliate of Allergan plc
Osteomyelitis
Safety and Efficacy of Dalbavancin Versus Active Comparator in Adult Patients With Osteomyelitis
This clinical study will be a multi-center, randomized, open-label, active-controlled, parallel-group study comparing dalbavancin to standard of care (SOC) therapy in osteomyelitis.
- Trial name
- NCT03091439
- Testing
- Dalbavancin, Standard of Care
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Allergan
Osteomyelitis
CERAMENT G as Part of the Surgical Treatment of Osteomyelitis in a Single-Stage Procedure
The study is a prospective cohort study of subjects where CERAMENT G was used as part of the surgical treatment of osteomyelitis in a single stage procedure.
- Trial name
- CERTITUDE (NCT06555848)
- Testing
- CERAMENT G
- Where
- United Kingdom
- Volunteers
- 128 people
- Sponsor
- BONESUPPORT AB
Stage IV Pressure Ulcer, Diabetic Foot Osteomyelitis
Expanded Access Program (EAP) STIMULAN VG
Individual (single) patient expanded access may be considered.
- Trial name
- EAPSTIMVG (NCT06808568)
- Testing
- STIMULAN VG
- Sponsor
- Biocomposites Ltd
Osteomyelitis, Diabetic Foot Osteomyelitis
Bacteriophage Therapy in Patients With Diabetic Foot Osteomyelitis
This is a phase 2b randomized trial designed to evaluate bacteriophage therapy in subjects with diabetic foot osteomyelitis.
- Trial name
- DANCE (NCT05177107)
- Testing
- Bacteriophage Therapy
- Where
- 15 sites in United States
- Volunteers
- 41 people
- Sponsor
- Adaptive Phage Therapeutics, Inc.
Osteomyelitis
Antibiotic Device for Osteomyelitis of the Extremities Pivotal Trial - Genex With Gentamicin.
The purpose of this trial is to determine if genex with gentamicin (genex G) an antibiotic loaded bone void filler, works to treat and is a safe option as part of the surgical treatment of osteomyelitis in the extremities.
- Trial name
- ADOPT GG (NCT07270380)
- Testing
- genex with gentamicin (genex G)
- Where
- 4 sites in United States
- Volunteers
- 139 people
- Sponsor
- Biocomposites Ltd
Infection; Diabetic Foot
Ertapenem Sodium (MK-0826) Versus Piperacillin/Tazobactam Sodium for the Treatment of Diabetic Foot Infections in Chinese Adults (MK-0826-061)
This study compared ertapenem sodium to piperacillin/tazobactam sodium for the treatment of moderate to severe diabetic foot infections.
- Trial name
- NCT01370616
- Testing
- Ertapenem sodium, Piperacillin/tazobactam sodium, Amoxicillin/clavulunate potassium
- Volunteers
- 565 people
- Sponsor
- Merck Sharp & Dohme LLC
Bacterial Infection
Study to Assess Safety and Clinical Activity of Local MBN-101 in Treatment of Infected Bone Sites
This study evaluates the safety and clinical benefit of MBN-101 administered intraoperatively to osteosynthesis or osteomyelitis sites for patients diagnosed with an orthopedic infection, with or without orthopaedic hardware.
- Trial name
- NCT02436876
- Testing
- MBN-101
- Where
- 6 sites in United States
- Volunteers
- 29 people
- Sponsor
- Microbion Corporation
Osteomyelitis
Dalbavancin vs Comparator in Pediatric Subjects With Acute Hematogenous Osteomyelitis
Dalbavancin for Pediatric Osteomyelitis
- Trial name
- AHOM (NCT02344511)
- Testing
- Dalbavancin, cefazolin, nafcillin, oxacillin or vancomycin
- Sponsor
- Durata Therapeutics International BV (an Affiliate of Actavis, Inc.)
Acute Hematogenous Osteomyelitis
Safety and Efficacy Study of Daptomycin Compared to Active Comparator in Pediatric Participants With Acute Hematogenous Osteomyelitis (AHO) (MK-3009-006)
The purpose of the study is to determine whether daptomycin is effective and safe in the treatment of pediatric participants with AHO when compared to vancomycin (or equivalent) or nafcillin (or β-lactam equivalent).
- Trial name
- NCT01922011
- Testing
- Daptomycin, Vancomycin (or equivalent), Nafcillin (or equivalent)
- Volunteers
- 149 people
- Sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Pressure Ulcer, Stage IV, Osteomyelitis
A Randomized Controlled Phase II Trial of STIMULAN VG vs Standard of Care (SoC) for the Treatment of Osteomyelitis Associated With Stage IV Pressure Ulcers.
The purpose of this trial is to assess the safety, tolerability and between-group effect size of STIMULAN VG (with debridement) and a course of systemic antibiotics to standard of care (debridement and systemic antibiotics only)…
- Trial name
- BLADE OPU2 (NCT06283979)
- Testing
- STIMULAN VG, Standard of Care
- Where
- 9 sites in United States
- Volunteers
- 60 people
- Sponsor
- Biocomposites Ltd
Diabetic Foot Infection
[124I]FIAU PET-CT Scanning in Diagnosing Osteomyelitis in Patients With Diabetic Foot Infection
This protocol will evaluate the sensitivity and specificity of [124I]FIAU as a diagnostic imaging agent for the detection of osteomyelitis in patients with diabetic foot infection.
- Trial name
- NCT01764919
- Testing
- [124I]FIAU
- Where
- 3 sites in United States
- Volunteers
- 4 people
- Sponsor
- BioMed Valley Discoveries, Inc
Chronic Osteomyelitis, Fracture Related Infection
CERAMENT G Device Registry
This is an Observational Device Registry Study of CERAMENT|G in normal use in accordance with the IFU. It will run for a period of three years from enrolment of the first patient into the Study at each Site, before being subject…
- Conditions
- Chronic Osteomyelitis, Fracture Related Infection, Diabetic Foot Osteomyelitis
- Trial name
- NCT06010433
- Testing
- CERAMENT G
- Where
- 3 sites in United States
- Volunteers
- 100 people
- Sponsor
- BONESUPPORT AB
Osteomyelitis
Study of Daptomycin in Subjects Undergoing Surgery for Osteomyelitis Associated With an Infected Prosthetic Caused by Staphylococci
This is a research study designed to look at the efficacy and safety of daptomycin given at a dose of 6 mg/kg or 8 mg/kg in subjects being treated for prosthetic hip or knee infections caused by Staphylococci.
- Trial name
- NCT00428844
- Testing
- daptomycin, vancomycin, teicoplanin
- Where
- 26 sites in United States, Russia and 1 more
- Volunteers
- 75 people
- Sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Acute Otitis Media, Mastoiditis
Impact of Prevnar 13 on Ear Infections in Children
Prevnar (7 valent pneumococcal conjugate vaccine [7vPnC]) has been shown to be effective against ear infections in children. Prevnar 13 is a new vaccine that is similar to Prevnar.
- Trial name
- NCT01272999
- Testing
- No intervention
- Where
- 8 sites in United States
- Volunteers
- 391 people
- Sponsor
- Pfizer
Bacterial Infections, Diabetic Foot
Study Evaluating the Safety and Efficacy of a Once-daily Dose of Tigecycline vs Ertapenem in Diabetic Foot Infections (DFI) With a Substudy in Patients With Diabetic Foot Infections Complicated by Osteomyelitis.
The purpose of this study was to look at the safety and effectiveness of a once-daily dose of tigecycline compared to ertapenem for the treatment of diabetic foot infections. The co-primary efficacy endpoints were not met.
- Conditions
- Bacterial Infections, Diabetic Foot, Osteomyelitis
- Trial name
- NCT00366249
- Testing
- Tigecycline, Ertapenem
- Where
- 211 sites in United States, Argentina and 37 more
- Volunteers
- 1,061 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Refractory Bone or Joint Infections
Oral Sodium Fusidate (CEM-102) for the Treatment of Staphylococcal Bone or Joint Infections
To evaluate the safety and effectiveness of oral sodium fusidate (CEM-102) as chronic antibiotic for the treatment of bone or joint infections.
- Trial name
- NCT02569541
- Testing
- sodium fusidate
- Where
- 19 sites in United States
- Volunteers
- 30 people
- Sponsor
- Arrevus Inc.
Bacterial Infections, Bone Diseases, Infectious
Fosfomycin I.v. for Treatment of Severely Infected Patients
The purpose of this European, multicentric, prospective, non-interventional study is to document and evaluate the efficacy and safety of the treatment of severely infected patients with intravenously administered fosfomycin…
- Conditions
- Bacterial Infections, Bone Diseases, Infectious, Osteomyelitis, Central Nervous System Bacterial Infections
- Trial name
- FORTRESS (NCT02979951)
- Where
- 50 sites in Austria, Germany and 3 more
- Volunteers
- 1,000 people
- Sponsor
- Infectopharm Arzneimittel GmbH
Diabetic Foot Osteomyelitis
A Feasibility Trial to Investigate the Safety and Between-group Effect Size of STIMULAN VG and Standard of Care (SoC) in Participants With Diabetic Foot Osteomyelitis
The purpose of this trial is to evaluate the safety and between-group effect size of STIMULAN VG compared to SoC treatment in patients with diabetic foot osteomyelitis (DFO).
- Trial name
- BLADE-VG2 (NCT05539963)
- Testing
- STIMULAN VG, Systemic Antibiotics
- Where
- 10 sites in United States
- Volunteers
- 61 people
- Sponsor
- Biocomposites Ltd