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

NCT03611634 | Unknown

• 1 other identifier: 18-126
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 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 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.

Conditions

Bone and Joint Infection

Keywords

gut microbiote, bone and joint infection, antibiotics

Outcome Measures

Primary Outcomes (1)

• BIOLOGICAL COLLECTION FROM SAMPLES 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.

  36 months

Study Arms (1)

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

Interventions

BIOLOGICAL COLLECTION FROM THE GUT MICROBIOTE OTHER

collection of saddles

BIOLOGICAL COLLECTION FROM THE GUT MICROBIOTE

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients having a bone or joint infection treated by a suppressive subcutaneous antibiotherapy with betalactamine

You may qualify if:

• 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

You may not qualify if:

• none

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hospices Civils de Lyon

Lyon, 69004, France

RECRUITING

Study Officials

• Tristan Ferry, Md,PhD

  Hospices Civils de Lyon - Hopital de la Croix Rousse

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eugenie mabrut

CONTACT

04 26 73 29 38; eugenie.mabrut@chu-lyon.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Research Assistant

Study Record Dates

• First Submitted: July 27, 2018
• First Posted: August 2, 2018
• Study Start: July 19, 2018
• Primary Completion: July 19, 2023
• Study Completion: July 19, 2024
• Last Updated: August 30, 2021

Record last verified: 2021-08

Locations

FR (1)