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Clinical Trials in France / NCT07056881
Recruiting Observational

Monotherapy vs Combination Therapy for Bone Infections Caused by Pseudomonas Aeruginosa

NCT07056881 · tracked via the Priya Life Science France tracker
Sponsor
Centre Hospitalier de Saint-Denis
Phase
Observational
Started
2025-04-11
Last updated
2025-07-09

Condition(s) studied

OsteomyelitisPseudomonas InfectionsPseudomonas AeruginosaBacterial Infections

Study summary

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • 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. — 6 weeks

Trial sites (1)

FacilityCityRegionStatus
Centre Hospitalier de Saint-Denis Saint-Denis France Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07056881 on ClinicalTrials.gov ↗ ← All trials in France