Stool Biobanking and Impact of Antimicrobials on the Gut Microbiota in Patients With Bone and Joint Infection (GUMIBONE)

Civil Hospices of Lyon

Status: Terminated

Conditions: Infection, Bacterial

Treatments: Biological: Patients treated by antibiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03633188

69HCL17_0652

2017-A02813-50 (Other Identifier)

Details and patient eligibility

About

Bone and joint infections (BJI) is a public health issue in industrialized countries.

Implant-associated BJI, are complex hospital-acquired infections and eradication of the pathogen is challenging in such patients.

A prolonged antimicrobial therapy is usually required from 6 weeks to 3 months, but some patients are eligible to several years of treatment and most of patients report gastrointestinal troubles, such as nausea and mild to severe diarrhea (but very few developed C. difficile diarrhea).

Moreover, the host gut microbiota is probably largely affected in abundance, richness and diversity. Indeed, it is known, that few days of antibiotics are sufficient to induce significant alterations of the gut microbiota, also called dysbiosis.

Severe dysbiosis, which is potentially irreversible and associated with a definitive shift in the gut microbiota metabolism and host homeostasis, may lead to and/or promote a large panel of severe diseases such as Clostridium difficile infection, diabetes mellitus, obesity, inflammatory bowel disease (IBD), cirrhosis, neurological disorders and cancer. It may also be associated with BJI recurrence and then impact global health costs.

The main objective of this study is to constitute biobanking of stools and perform DNA sequencing of the gut microbiota in patients with acute or sub-acute implant-related Bone and Joint Infection (BJI), caused by Staphylococcus aureus.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. The subject is willing, able to understand and comply to the protocol requirement
2. More than 18-years-old
3. Subject with suspicion of implant-related BJI within 3 months after surgery and treated by antibiotherapy for a maximal duration of six months
4. Subject signed Inform Consent Form
5. Contraception for women of childbearing age

Exclusion criteria

1. Pregnancy
2. Severe disease with a life expectancy < 3months
3. Any antibiotherapy treated all diseases in the 14 days before inclusion
4. Guardianship, curatorship patients
5. Patient non-affiliated to health care system
6. Patient under the power of law

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Patients treated by antibiotherapy

Experimental group

Description:

35 Patients treated by antibiotherapy for acute and subacute post-operative implant-associated BJI infections and among them 10 patients with Staphylococcus. aureus treated with antibiotics as part of their standard treatment procedure for metagenomic procedure.

Treatment:

Biological: Patients treated by antibiotherapy