Monotherapy vs Combination Therapy for Bone Infections Caused by Pseudomonas Aeruginosa
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCentre Hospitalier de Saint-Denis
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
No isolation of Pseudomonas aeruginosa
No imaging evidence suggestive of osteomyelitis
Patients under 18 years of age
Trial population
Participants will be selected from the electronic health records of adult patients hospitalized within the AP-HP (Assistance Publique-Hôpitaux de Paris) network. The study population includes individuals diagnosed with osteitis or osteomyelitis who have a confirmed microbiological diagnosis of Pseudomonas aeruginosa infection, along with imaging consistent with bone infection.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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 weeksSponsors and contacts
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Source ClinicalTrials.gov