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

NCT03633188 | Terminated

• 2 other identifiers: 69HCL17_06522017-A02813-50
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Infection, Bacterial

Keywords

Bone and Joint Infections (BJI); gut dysbiosis; antimicrobial resistance; antibiotic resistance gene; mobile genetic elements

Outcome Measures

Primary Outcomes (1)

• change in the gut microbiota after treatment

  stools will be collected to 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. Stools will be collected at baseline, during antibiotic treatment (Week 2), at the end of treatment (Week 6 or Week 24),15 days after antibiotherapy stop (Week 8 or Week 26), and W26 after baseline.

  from baseline to week 26

Secondary Outcomes (8)

• Assessment of the evolution of intensity of Diarrheic Symptoms

  from baseline to week 8 or week 26

• Assessment of the evolution of frequency of Diarrheic Symptoms

  from baseline to week 8 or week 26

• Quantity of rectal acquisition of Multi Drug Resistance (MDR) bacteria under antibiotics measured by classic culture and quantification culture methods

  at week 6 or week 24

• gut dysbiosis measured by Next Generation Sequencing (NGS)

  from baseline to week 26

• severe post-antibiotic dysbiosis (SPAD) measured by Next Generation Sequencing (NGS)

  from baseline to week 26

Study Arms (1)

Patients treated by antibiotherapy

EXPERIMENTAL

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.

Biological: Patients treated by antibiotherapy

Interventions

Patients treated by antibiotherapy 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),

Patients treated by antibiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Pregnancy
• Severe disease with a life expectancy \< 3months
• Guardianship, curatorship patients
• Patient non-affiliated to health care system
• Patient under the power of law

Sponsors & Collaborators

• Hospices Civils de Lyon: lead
• University of Lyon: collaborator

Study Sites (4)

Hôpital de la Croix Rousse-Service de chirurgie orthopédique

Lyon, 69004, France

Location

Hôpital de la Croix Rousse-Service des Maladies Infectieuses et Tropicales

Lyon, 69004, France

Location

Centre Hospitalier Lyon Sud-Service de Chirurgie Orthopédique

Pierre-Bénite, 69310, France

Location

Centre Hospitalier Lyon Sud-Service des maladies infectieuses

Pierre-Bénite, 69310, France

Location

MeSH Terms

Conditions

Bacterial Infections

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections

Study Officials

• Tristan FERRY, Pr

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2018
• First Posted: August 16, 2018
• Study Start: July 19, 2018
• Primary Completion: August 28, 2020
• Study Completion: August 28, 2020
• Last Updated: February 5, 2021

Record last verified: 2021-02

Locations

FR (4)