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

Sponsor

Hospices Civils de Lyon (Other)

Overall Status

Recruiting

CT.gov ID

NCT03611634

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bone and Joint Infection	Other: BIOLOGICAL COLLECTION FROM THE GUT MICROBIOTE

Study Design

Study Type:

Observational

Anticipated Enrollment :

20 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jul 19, 2018

Anticipated Primary Completion Date :

Jul 19, 2023

Anticipated Study Completion Date :

Jul 19, 2024

Arms and Interventions

Arm	Intervention/Treatment
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.	Other: BIOLOGICAL COLLECTION FROM THE GUT MICROBIOTE collection of saddles

Arm

Intervention/Treatment

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.

Other: BIOLOGICAL COLLECTION FROM THE GUT MICROBIOTE

collection of saddles

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Exclusion Criteria:

none

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospices Civils de Lyon	Lyon		France	69004

Sponsors and Collaborators

Hospices Civils de Lyon

Investigators

Principal Investigator: Tristan Ferry, Md,PhD, Hospices Civils de Lyon - Hopital de la Croix Rousse

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Eugénie MABRUT, Clinical Research Assistant, Hospices Civils de Lyon

ClinicalTrials.gov Identifier:

NCT03611634

Other Study ID Numbers:

18-126

First Posted:

Aug 2, 2018

Last Update Posted:

Aug 30, 2021

Last Verified:

Aug 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Eugénie MABRUT, Clinical Research Assistant, Hospices Civils de Lyon

gut microbiote, bone and joint infection, antibiotics

Additional relevant MeSH terms:

Infections

Communicable Diseases

Arthritis, Infectious

Study Results

No Results Posted as of Aug 30, 2021