Monotherapy vs Combination Therapy for Bone Infections Caused by Pseudomonas Aeruginosa

NCT ID: NCT07056881

Last Updated: 2025-07-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-04-11

Study Completion Date

2026-04-15

Brief Summary

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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.

Detailed Description

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Conditions

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Osteomyelitis Pseudomonas Infections Pseudomonas Aeruginosa Bacterial Infections

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier de Saint-Denis

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Centre Hospitalier de Saint-Denis

Saint-Denis, France, France

Site Status RECRUITING

Countries

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France

Facility Contacts

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Raphaël PODOLAK

Role: primary

0142356208

Other Identifiers

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0108_REANIMATION_OPERA

Identifier Type: -

Identifier Source: org_study_id

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