Biological Collection From Samples From The Gut Microbiota In Patients Having A Bone Or Joint Infection Treated By A Suppressive Subcutaneous Antibiotherapy With Betalactamine (CARBAMICROBIOTA)
Constitution Of A Biological Collection From Samples From The Gut Microbiota In Patients Having A Bone Or Joint Infection Treated By A Suppressive Subcutaneous Antibiotherapy With Betalactamine (CARBAMICROBIOTA)
1 other identifier
observational
14
1 country
1
Brief Summary
Optimal surgical therapy (debridement in chronic osteomyelitis; device exchange in patients with chronic prosthetic joint infection (PJI)) could be sometimes non-feasible, especially in the elderly population. Therefore, a medical therapy with oral prolonged suppressive antibiotic therapy (PSAT) seems to be an option to prevent recurrence and prosthesis loosening. Unfortunately, some patients are infected with resistant pathogens for which oral antibiotics are not suitable. Subcutaneous (SC) administration of injectable intravenous antibiotics as prolonged suppressive antibiotic therapy could be a convenient way to limit catheter-related complications and facilitate ambulatory care. However, there are few data concerning the development of resistance under subcutaneous prolonged treatment with betalactamine. The aim of this study is just to constitute a biological collection from samples from the Gut microbiota in patients having a bone or joint infection treated by a suppressive subcutaneous antibiotherapy with betalactamine. Later analysis will be led on those samples to detect the acquisition of resistance or not.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Oct 2018
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 28, 2018
CompletedFirst Posted
Study publicly available on registry
June 8, 2018
CompletedStudy Start
First participant enrolled
October 11, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 8, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 8, 2024
CompletedDecember 9, 2025
December 1, 2025
5.5 years
May 28, 2018
December 2, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Biological Collection From Samples From The Gut Microbiota
The aim of this study is just to constitute a biological collection from samples from the Gut microbiota in patients having a bone or joint infection treated by a suppressive subcutaneous antibiotherapy with betalactamine. No analysis will be done for instance.
1 day
Interventions
The aim of this study is just to constitute a biological collection from samples from the Gut microbiota in patients having a bone or joint infection treated by a suppressive subcutaneous antibiotherapy with betalactamine. No analysis will be done for instance.
Eligibility Criteria
Patients having a bone or joint infection treated by a suppressive subcutaneous antibiotherapy with betalactamine.
You may qualify if:
- Patients having a bone or joint infection
- Patients treated by a suppressive subcutaneous antibiotherapy with betalactamine
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre de référence des infections ostéo-articulaires de Lyon - Hôpital de la Croix-Rousse
Lyon, 69004, France
Biospecimen
Biological collection from samples from the GUT microbiota in patients having a bone or joint infection treated by a suppressive subcutaneous antibiotherapy with betalactamine. No analysis will be done for instance.
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 28, 2018
First Posted
June 8, 2018
Study Start
October 11, 2018
Primary Completion
April 8, 2024
Study Completion
April 8, 2024
Last Updated
December 9, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share