Consitution Of A Biological Collection From Samples From The Gut Microbiote In Patients Having A Bone Or Joint Infection Treated By A Suppressive Subcutaneous Antibiotherapy With Betalactamine

• Conditions: Bone and Joint Infection
• Interventions: Other: BIOLOGICAL COLLECTION FROM THE GUT MICROBIOTE

• Registration Number: NCT03611634
• Lead Sponsor: Hospices Civils de Lyon

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 PSAT 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 is just to constitute a biological collection from samples from the GUT microbiote 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-07-19
• Study First Submitted: 2018-07-27
• Study First Submitted QC: 2018-07-27
• Study First Posted: 2018-08-02
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-27
• Last Update Posted: 2021-08-30
• Primary Completion: 2023-07-19
• Study Completion: 2024-07-19

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Patients having an ostéo-articular infection (on material or on native bone) and having an indication of antibiotic treatment suppressive subcutaneous by betalactamine and managed at the Croix-Rousse Hospital
• Patients not opposed to participate to the study

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Exclusion Criteria

• none

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
BIOLOGICAL COLLECTION FROM THE GUT MICROBIOTE	BIOLOGICAL COLLECTION FROM THE GUT MICROBIOTE	The aim of this study is just to constitute a biological collection from samples from the GUT microbiote in patients having a bone or joint infection treated by a suppressive subcutaneous antibiotherapy with betalactamine. No analysis will be done for instance.

Primary Outcome Measures

Name	Time	Method
BIOLOGICAL COLLECTION FROM SAMPLES FROM THE GUT MICROBIOTE	36 months	The aim of this study is just to constitute a biological collection from samples from the GUT microbiote in patients having a bone or joint infection treated by a suppressive subcutaneous antibiotherapy with betalactamine. No analysis will be done for instance.

Trial Locations

Locations (1)

Hospices Civils de Lyon; 🇫🇷 Lyon, France