Clinical trial Recruiting at 1 site Observational Ages 18 and up

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 typeObservational
Ages18 Years and up
SexAll
Enrollment300 (estimated)
SponsorCentre Hospitalier de Saint-Denis
Academic / other
Locations1 site (Saint-Denis, France)
StatusRecruiting
StartedApril 11, 2025
Main results expectedApril 15, 2026
Study endsApril 15, 2026
Registry record updatedJuly 9, 2025
Trial IDNCT07056881 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

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.