Single antibiotic versus two antibiotics for Pseudomonas bone infection
Monotherapy vs Combination Therapy for Bone Infections Caused by Pseudomonas Aeruginosa
Centre Hospitalier de Saint-Denis · NCT07056881
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 |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier de Saint-Denis (other) |
| Locations | 1 site (Saint-Denis, France) |
| Trial ID | NCT07056881 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Children, patients without culture-confirmed Pseudomonas aeruginosa, or those lacking imaging evidence of bone infection are unlikely to benefit from participation.
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 performed: Existing evidence comparing monotherapy and combination therapy for Pseudomonas bone infections is limited and mixed, with few direct comparative datasets.
Eligibility criteria
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 this trial is running
Saint-Denis, France
- Centre Hospitalier de Saint-Denis — Saint-Denis, France, France (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Osteomyelitis, Pseudomonas Infections, Pseudomonas Aeruginosa, Bacterial Infections