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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-19

Study Completion Date

2020-08-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Infection, Bacterial

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Patients treated by antibiotherapy

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.

Group Type EXPERIMENTAL

Patients treated by antibiotherapy

Intervention Type BIOLOGICAL

Biological samples (stool, blood, swabs) will be collected :

* Blood sampling (12 ml) at baseline (week 0) at the end of treatment (W6/W24),and 15 days after antibiotherapy stop (optional) (W8/W26),
* Feces collection at baseline (week 0) during antibiotic treatment (W2), at the end of treatment (W6/W24),15 days after antibiotherapy stop (W8/W26), and W26 after baseline
* Swab samples (nasal and rectal) at baseline at week 0 and at the end of treatment (W6/W24),

Interventions

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Patients treated by antibiotherapy

Biological samples (stool, blood, swabs) will be collected :

* Blood sampling (12 ml) at baseline (week 0) at the end of treatment (W6/W24),and 15 days after antibiotherapy stop (optional) (W8/W26),
* Feces collection at baseline (week 0) during antibiotic treatment (W2), at the end of treatment (W6/W24),15 days after antibiotherapy stop (W8/W26), and W26 after baseline
* Swab samples (nasal and rectal) at baseline at week 0 and at the end of treatment (W6/W24),

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No