Monotherapy vs Combination Therapy for Bone Infections Caused by Pseudomonas Aeruginosa

NCT07056881 | Recruiting

• 1 other identifier: 0108_REANIMATION_OPERA
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Osteomyelitis; Pseudomonas Infections; Pseudomonas Aeruginosa; Bacterial Infections

Outcome Measures

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.

  6 weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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)

You may not qualify if:

• No isolation of Pseudomonas aeruginosa
• No imaging evidence suggestive of osteomyelitis
• Patients under 18 years of age

Sponsors & Collaborators

• Centre Hospitalier de Saint-Denis: lead

Study Sites (1)

Centre Hospitalier de Saint-Denis

Saint-Denis, France, France

RECRUITING

MeSH Terms

Conditions

Osteomyelitis; Pseudomonas Infections; Bacterial Infections

Condition Hierarchy (Ancestors)

Bone Diseases, Infectious; Infections; Bone Diseases; Musculoskeletal Diseases; Gram-Negative Bacterial Infections; Bacterial Infections and Mycoses

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2025
• First Posted: July 9, 2025
• Study Start: April 11, 2025
• Primary Completion: April 15, 2026
• Study Completion: April 15, 2026
• Last Updated: July 9, 2025

Record last verified: 2025-06

Locations

FR (1)