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

Bone and Joint Infection Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03611634
• Other study ID #: 18-126
• Status: Recruiting
• Start date: July 19, 2018
• Est. completion date: July 19, 2024

Study information

• Verified date: August 2021
• Source: Hospices Civils de Lyon
• Contact: Eugenie mabrut
• Phone: 04 26 73 29 38
• Email: eugenie.mabrut[@]chu-lyon.fr
• Is FDA regulated: No
• 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: July 19, 2024
• Est. primary completion date: July 19, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis, Infectious
• Bone and Joint Infection
• Communicable Diseases
• Infection

Intervention

Other:
• BIOLOGICAL COLLECTION FROM THE GUT MICROBIOTE
collection of saddles

Locations

Country	Name	City	State
France	Hospices Civils de Lyon	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 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