Monotherapy vs Combination Therapy for Bone Infections Caused by Pseudomonas Aeruginosa
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Osteomyelitis, Pseudomonas Infections, Pseudomonas Aeruginosa, Bacterial Infections. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
This study looks at how well one antibiotic (monotherapy) works compared to two antibiotics (combination therapy) in treating bone infections caused by Pseudomonas aeruginosa. It includes 300 adult patients who had this type of infection confirmed by lab tests and medical imaging. The goal is to find out if using just one antibiotic is as effective as using two, while also looking at side effects, the need for more surgery, antibiotic resistance, and overall antibiotic use.
Primary outcome measures
- Clinical cure rate at the end of antibiotic treatment, defined as resolution of signs and symptoms of infection without need for additional antibiotic therapy or surgical intervention. [Time frame: 6 weeks]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- Centre Hospitalier de Saint-Denis — Saint-Denis
Identifiers
NCT: NCT07056881 · 0108_REANIMATION_OPERA