Actively Recruiting
Monotherapy vs Combination Therapy for Bone Infections Caused by Pseudomonas Aeruginosa
Led by Centre Hospitalier de Saint-Denis · Updated on 2025-07-09
300
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating how effective one antibiotic alone (monotherapy) is compared to using two antibiotics together (combination therapy) for treating bone infections caused by the bacteria Pseudomonas aeruginosa. This study involves 300 adults who have confirmed infections based on lab tests and medical imaging. The purpose is to determine if using just one antibiotic works as well as two, while also monitoring side effects, surgery needs, resistance to antibiotics, and overall antibiotic use. The study observes adult patients diagnosed with osteomyelitis caused by Pseudomonas aeruginosa. Participants are followed during their antibiotic treatment to assess cure rates at the end of therapy, which lasts about six weeks. The study does not involve assigning treatments but collects data on how monotherapy compares to combination therapy in real-world care. Participants will undergo clinical assessments, lab tests, and imaging to confirm infection and monitor progress. Researchers will measure the clinical cure rate defined as resolution of infection signs and symptoms without needing extra antibiotics or surgery. The study helps understand antibiotic effectiveness and safety in treating this serious bone infection. Total participation duration corresponds to the treatment period and follow-up to confirm cure, approximately six weeks.
CONDITIONS
Brief Title
Monotherapy vs Combination Therapy for Bone Infections Caused by Pseudomonas Aeruginosa
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients (18 years old or older)
- Diagnosis of osteitis or osteomyelitis due to Pseudomonas aeruginosa
- Pseudomonas aeruginosa isolated 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 will not qualify if you...
- No isolation of Pseudomonas aeruginosa
- No imaging evidence suggestive of osteomyelitis
- Patients under 18 years of age
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 weeks
Participants are observed to assess clinical cure rates after antibiotic treatment for bone infections caused by Pseudomonas aeruginosa.
Visits as per routine clinical care during antibiotic treatment
Trial Site Locations
Total: 1 location
1
Centre Hospitalier de Saint-Denis
Saint-Denis, France, France
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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