Single antibiotic versus two antibiotics for Pseudomonas bone infection
Official title: Monotherapy vs Combination Therapy for Bone Infections Caused by Pseudomonas Aeruginosa
Run by Centre Hospitalier de Saint-Denis · NCT07056881 · Data updated 2026-11-12
This study will test whether one antibiotic works as well as two for adults with bone infections caused by Pseudomonas aeruginosa.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 300 (estimated) |
| Sponsor | Centre Hospitalier de Saint-Denis Academic / other |
| Locations | 1 site (Saint-Denis, France) |
| Status | Recruiting |
| Started | April 11, 2025 |
| Main results expected | April 15, 2026 |
| Study ends | April 15, 2026 |
| Registry record updated | July 9, 2025 |
| Trial ID | NCT07056881 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (age 18 or older) with osteitis or osteomyelitis confirmed by imaging and with Pseudomonas aeruginosa isolated from at least one deep sterile sample are ideal candidates.
✕Probably not a fit
Children, patients without culture-confirmed Pseudomonas aeruginosa, or those lacking imaging evidence of bone infection are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study will follow 300 adults with culture-confirmed Pseudomonas aeruginosa osteomyelitis and compare outcomes between those treated with monotherapy and those given combination antibiotic therapy. Clinical data, imaging results, microbiology reports, surgical interventions, adverse events, and total antibiotic exposure will be recorded. Primary comparisons include treatment success, need for additional surgery, emergence of antibiotic resistance, adverse effects, and overall antibiotic use. Analyses will adjust for baseline differences between groups using standard clinical definitions for cure and failure.
Why it matters
Potential benefit: If results show one drug is as effective as two, patients could avoid extra antibiotics, reducing side effects and overall antibiotic exposure.
How similar studies have gone: Existing evidence comparing monotherapy and combination therapy for Pseudomonas bone infections is limited and mixed, with few direct comparative datasets.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients (≥18 years old) * Diagnosis of osteitis or osteomyelitis due to Pseudomonas aeruginosa * Isolation of Pseudomonas aeruginosa from at least one deep, sterile sample (e.g., bone biopsy, joint aspiration) * Imaging findings consistent with osteomyelitis (MRI, CT scan, or X-ray) Exclusion Criteria: * No isolation of Pseudomonas aeruginosa * No imaging evidence suggestive of osteomyelitis * Patients under 18 years of age
Where it's running
-
Centre Hospitalier de Saint-Denis
Saint-Denis, France, France Recruiting
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Assessing treatments for difficult-to-treat Pseudomonas infections
This study is testing different antibiotic treatments for tough Pseudomonas infections to see which ones work best for patients needing intravenous therapy.
-
Using fosfomycin to treat severely infected patients
This study is testing if an intravenous antibiotic called fosfomycin can safely help people with serious infections like osteomyelitis and bacterial meningitis feel better.
-
Population pharmacokinetics of rifampicin in staphylococcal osteoarticular infections
This study tests how rifampicin behaves in the body of adults with staphylococcal osteoarticular infections when given with levofloxacin or ciprofloxacin, to see how drug exposure relates to tolerance and outcomes.
-
CTX-187 first-in-human test in healthy people and people with chronic bronchiectasis and Pseudomonas infection
This study tests CTX-187 to see if it is safe and tolerable when given as IV infusions to healthy adults and adults with chronic bronchiectasis and Pseudomonas aeruginosa infection.
-
Personalized beta-lactam dosing in cirrhosis patients with bacterial infections
This study tests whether tailoring beta-lactam dosing based on patient liver disease and drug levels can help people with cirrhosis and bacterial infections.
-
Vaginitis Diagnostic Algorithm Pilot Using Nanopath and Other Tests
This study tests a new Nanopath vaginal test to see if it correctly detects vaginitis-causing pathogens in up to 1,000 people with vaginitis symptoms.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.