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NCT03550911 Clinical Trial

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)

Joint Infection Clinical Trial

Official title:
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)

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03550911
Other study ID # 69HCL18_0014
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 11, 2018
Est. completion date October 11, 2025

Study information
Verified date November 2023
Source Hospices Civils de Lyon
Contact Tristan FERRY, MD, PhD
Phone 04 72 07 11 07
Email tristan.ferry@chu-lyon.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 26
Est. completion date October 11, 2025
Est. primary completion date October 11, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients having a bone or joint infection - Patients treated by a suppressive subcutaneous antibiotherapy with betalactamine Exclusion Criteria: - None

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• 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.

Locations
Country Name City State
France Centre de référence des infections ostéo-articulaires de Lyon - Hôpital de la Croix-Rousse Lyon

Sponsors (1)
Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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