Monotherapy vs Combination Therapy for Bone Infections Caused by Pseudomonas Aeruginosa

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07056881

Enrollment

300

Registered

2025-07-09

Start date

2025-04-11

Completion date

2026-04-15

Last updated

2025-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bacterial Infections, Osteomyelitis, Pseudomonas Aeruginosa, Pseudomonas Infections

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
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

Countries

France

Outcome results