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InterventiOnal Study of Bone and Joint Infections Related Gut dysbiosIS (OSIRIS)

Primary Purpose

Bone and Joint Infection

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Biological samples collection of blood and feces
Sponsored by
MaaT Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Bone and Joint Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Consenting subjects with BJI (native or material related BJI) at participating sites who are being treated with antibiotics as part of their standard treatment procedure will be enrolled
  • The subject is willing, able to understand and comply to the protocol requirement
  • More than 18-years-old
  • Subject is suspected for implanted or native BJI and is eligible for antibiotics treatment
  • Subject signed Inform Consent Form

Exclusion Criteria:

  • Pregnancy
  • Severe disease with a life expectancy < 3 months
  • Antibiotherapy in the 14 days before inclusion in the study
  • Patient non-affiliated to health care system
  • Patient under the power of law
  • Guardianship, curators patients

Sites / Locations

  • CHU Bordeaux
  • HCL Croix-Rousse
  • CHU de Nantes
  • GH Diaconesses-Croix Saint Simon
  • CH Tourcoing

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental arm

Arm Description

Outcomes

Primary Outcome Measures

Evolution of intensity and frequency of Diarrheic Symptoms
Assessment of the evolution of intensity and frequency of Diarrheic Symptoms from baseline, during antibiotic treatment (W2), at the end of treatment (W6-12) and 15 days after antibiotherapy treatment stop (W8-14)

Secondary Outcome Measures

Characterization of the gut dysbiosis and its prevalence in patients with BJI and under antibiotic treatment : measured by NGS (Next-Generation Sequencing) method

Full Information

First Posted
December 27, 2016
Last Updated
April 4, 2018
Sponsor
MaaT Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT03011502
Brief Title
InterventiOnal Study of Bone and Joint Infections Related Gut dysbiosIS
Acronym
OSIRIS
Official Title
InterventiOnal Study of Bone and Joint Infections Related Gut dysbiosIS
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
December 2016 (undefined)
Primary Completion Date
March 27, 2018 (Actual)
Study Completion Date
March 27, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MaaT Pharma

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Gut dysbiosis is an intestinal disorder that is characterized by accumulation of microbiota imbalance, host-microbiota crosstalk dysfunction and inflammation. As part of its clinical development, MaaT (Microbiota as a Therapy) Pharma is particularly interested in patients with Bone and Joint Infections (BJI). These patients are treated with antibiotics having significant consequences on their intestinal flora, causing intestinal discomfort, which can be manifested by diarrhea. MaaT Pharma wishes to carry out a clinical study, OSIRIS, in collaboration with Prof. Tristan Ferry, member and coordinator of CRIOAc (Centre de Référence des Infections Ostéo-Articulaires Complexes) Lyon, Center of Reference of Bone and Joint Infections (BJI). The objective of this study is to follow patients with treated BJI in order to characterize intestinal dysbiosis and the future relevance of an autologous Fecal Microbiota Transplantation (aFMT) intervention. To do this, patients will be monitored according to the current CRIOAc recommendations, with the aim of taking biological samples from patients at the same time as scheduled visits, routine monitoring patients. Only one additional consultation will be carried out 15 days after stopping the antibiotics in order to better evaluate the dysbiosis evolution. Thus biological samples (blood, stool, nasal, rectal) will be taken during the follow-up consultations over a period of 6 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone and Joint Infection

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental arm
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Biological samples collection of blood and feces
Primary Outcome Measure Information:
Title
Evolution of intensity and frequency of Diarrheic Symptoms
Description
Assessment of the evolution of intensity and frequency of Diarrheic Symptoms from baseline, during antibiotic treatment (W2), at the end of treatment (W6-12) and 15 days after antibiotherapy treatment stop (W8-14)
Time Frame
From baseline, up to 15 days after antibiotherapy treatment stop (Week 8 to week 14)
Secondary Outcome Measure Information:
Title
Characterization of the gut dysbiosis and its prevalence in patients with BJI and under antibiotic treatment : measured by NGS (Next-Generation Sequencing) method
Time Frame
Between baseline, after antibiotherapy treatment stop (Week 8-14) and the end of the follow-up (6 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Consenting subjects with BJI (native or material related BJI) at participating sites who are being treated with antibiotics as part of their standard treatment procedure will be enrolled The subject is willing, able to understand and comply to the protocol requirement More than 18-years-old Subject is suspected for implanted or native BJI and is eligible for antibiotics treatment Subject signed Inform Consent Form Exclusion Criteria: Pregnancy Severe disease with a life expectancy < 3 months Antibiotherapy in the 14 days before inclusion in the study Patient non-affiliated to health care system Patient under the power of law Guardianship, curators patients
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tristan Ferry, MD, PhD
Organizational Affiliation
Hôpitaux civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Bordeaux
City
Bordeaux
Country
France
Facility Name
HCL Croix-Rousse
City
Lyon
Country
France
Facility Name
CHU de Nantes
City
Nantes
Country
France
Facility Name
GH Diaconesses-Croix Saint Simon
City
Paris
Country
France
Facility Name
CH Tourcoing
City
Tourcoing
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

InterventiOnal Study of Bone and Joint Infections Related Gut dysbiosIS

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