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Osteoarticular infections on prosthesis: impact of three antibiotic therapies on the digestive microbiota
EU CTIS ID: 2024-513298-29-00
What this study is testing
To compare the evolution between D1 and D5 of the biodiversity of the gut microbiota between populations treated with cefepime+daptomycin (C+D) or piperacillin-tazobactam+daptomycin (PT+D) or ceftobiprole (CFB) in the context of suspected osteoarticular infection on material (IOAM). The diversity of each patient's gut microbiota is determined by targeted 16S rDNA metagenomics
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age≥ 18 years old
- Indication for prosthetic revision or total shoulder prosthesis or revision of internal osteosynthesis material with suspected IOAM
- Normal CPK level according to the standard set by the laboratory
You likely can't join if
- Antibiotic therapy within the previous 3 months
- Clinical or radiological signs making IOAM highly likely
- Positive bacterial culture (strict pathogen) of a joint puncture prior to revision
- Inflammatory bowel disease
- Hypersensitivity to cefepime or to piperacillin+tazobactam or to ceftobiprole or any of the excipients or to other beta-lactam
- Renal impairment with GFR < 50ml/min/1.73 m2 (CKD-EPI)
See the full eligibility criteria
- Age≥ 18 years old
- Indication for prosthetic revision or total shoulder prosthesis or revision of internal osteosynthesis material with suspected IOAM
- Normal CPK level according to the standard set by the laboratory
- Antibiotic therapy within the previous 3 months
- Clinical or radiological signs making IOAM highly likely
- Positive bacterial culture (strict pathogen) of a joint puncture prior to revision
- Inflammatory bowel disease
- Hypersensitivity to cefepime or to piperacillin+tazobactam or to ceftobiprole or any of the excipients or to other beta-lactam
- Renal impairment with GFR < 50ml/min/1.73 m2 (CKD-EPI)
- Treatment with bosentan and/or Probenecid treatment
- Pre-existing seizure disorder
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.