Clinical trial NCT03633188: Stool Biobanking and Impact of Antimicrobials on the Gut Microbiota in Patients With Bone and Joint Infection
Official title: Stool Biobanking and Impact of Antimicrobials on the Gut Microbiota in Patients With Bone and Joint Infection
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Infection, Bacterial
Keywords: Bone and Joint Infections (BJI)
gut dysbiosis
antimicrobial resistance
antibiotic resistance gene
mobile genetic elements
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
Collaborators: name: University of Lyon
First posted: 2018-08-16
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: change in the gut microbiota after treatment
timeFrame: from baseline to week 26
Secondary outcomes:
measure: Assessment of the evolution of intensity of Diarrheic Symptoms
timeFrame: from baseline to week 8 or week 26
measure: Assessment of the evolution of frequency of Diarrheic Symptoms
timeFrame: from baseline to week 8 or week 26
measure: Quantity of rectal acquisition of Multi Drug Resistance (MDR) bacteria under antibiotics measured by classic culture and quantification culture methods
timeFrame: at week 6 or week 24
measure: gut dysbiosis measured by Next Generation Sequencing (NGS)
timeFrame: from baseline to week 26
measure: severe post-antibiotic dysbiosis (SPAD) measured by Next Generation Sequencing (NGS)
timeFrame: from baseline to week 26
measure: Identification of markers of the gut dysbiosis (inflammatory proteins) measured by Elisa techniques
timeFrame: from baseline to week 26
measure: Analysis of impact of Bone and Joint Infection on health-related quality of life in patients by EQ5D5L questionnaires
timeFrame: from baseline to week 26
measure: Analysis of impact of Bone and Joint Infection on health-related quality of life in patients by EQ5D3L questionnaire
timeFrame: from baseline to week 26
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hôpital de la Croix Rousse-Service de chirurgie orthopédique
city: Lyon
country: France
facility: Hôpital de la Croix Rousse-Service des Maladies Infectieuses et Tropicales
city: Pierre Benite
country: France
facility: Centre Hospitalier Lyon Sud-Service de Chirurgie Orthopédique
city: Pierre Bénite
country: France
facility: Centre Hospitalier Lyon Sud-Service des maladies infectieuses
Study officials:
affiliation: Hospices Civils de Lyon
name: Tristan FERRY, Pr
role: PRINCIPAL_INVESTIGATOR
References: