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RecruitingNCT07056881Updated Jul 9, 2025

Monotherapy vs Combination Therapy for Bone Infections Caused by Pseudomonas Aeruginosa

An observational study in Osteomyelitis, Pseudomonas Infections and Pseudomonas Aeruginosa, sponsored by Centre Hospitalier de Saint-Denis. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-09.

Sponsored by Centre Hospitalier de Saint-Denis · Observational

From the registry’s dates

  • Primary completion was expected by Apr 2026, 6 months ago, but the record still lists the study as recruiting.
  • Started Apr 2025; still recruiting 1 year 7 months later.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
300
Ages
18 Years and older
Sex
All
01

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.

02

Conditions studied

  • Osteomyelitis
  • Pseudomonas Infections
  • Pseudomonas Aeruginosa
  • Bacterial Infections
03

In context

Osteomyelitis

105 studies on the registry are indexed under Osteomyelitis; 30 are open to participants now.

This study's planned enrollment of 300 is above the median of 86 across 41 observational studies indexed under Osteomyelitis.

Browse Osteomyelitis studies →

Lead sponsor

Centre Hospitalier de Saint-Denis is the lead sponsor of 45 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 , joint aspiration)
  • Imaging findings consistent with osteomyelitis (MRI, CT scan, or X-ray)

Exclusion criteria

Exclusion Criteria:

  • No isolation of Pseudomonas aeruginosa
  • No imaging evidence suggestive of osteomyelitis
  • Patients under 18 years of age
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
300 participants (estimated)
Patient registry
No
06

What researchers measure

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

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 9, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07056881
Lead sponsor
Centre Hospitalier de Saint-Denis
Responsible party
Sponsor
First posted
Jul 9, 2025
Start date
Apr 11, 2025
Primary completion
Apr 15, 2026 (estimated)
Completion
Apr 15, 2026 (estimated)
Last update
Jul 9, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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