Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07056881

Monotherapy vs Combination Therapy for Bone Infections Caused by Pseudomonas Aeruginosa

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Osteomyelitis Bacterial Infections Bacterial Infections and Mycoses Bone Diseases Bone Diseases, Infectious Gram-Negative Bacterial Infections Infections Musculoskeletal Diseases Pseudomonas Aeruginosa Pseudomonas Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier de Saint-Denis

Saint-Denis, France

Location status: Recruiting

Location contact

Raphaël PODOLAK

CONTACT

[email protected]

0142356208

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 weeks

Sponsors and collaborators

Lead sponsor

Centre Hospitalier de Saint-Denis

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 9, 2025
Registry last updated
Jul 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.