InterventiOnal Study of Bone and Joint Infections Related... | NCT03011502

Studies
InterventiOnal Study of Bone and Joint Infections Related Gut dysbiosIS

NCT03011502

Sponsor

MaaT Pharma

Status

Completed

Last Update Posted

Apr 5, 2018Actual

Enrollment

62Actual

Phase

Not Applicable

Conditions

Bone and Joint Infection

Interventions

Biological samples collection of blood and feces

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2016

Primary Completion Date

Mar 27, 2018Actual

Completion Date

Mar 27, 2018Actual

First Submitted Date

Dec 27, 2016

First Submission Date that Met QC Criteria

Jan 3, 2017

First Posted Date

Jan 5, 2017Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 4, 2018

Last Update Posted Date

Apr 5, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

62Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Experimental arm	Experimental		Other: Biological samples collection of blood and feces

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Biological samples collection of blood and feces	Other		Experimental arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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)	From baseline, up to 15 days after antibiotherapy treatment stop (Week 8 to week 14)

Secondary Outcomes

Measure	Description	Time Frame
Characterization of the gut dysbiosis and its prevalence in patients with BJI and under antibiotic treatment : measured by NGS (Next-Generation Sequencing) method		Between baseline, after antibiotherapy treatment stop (Week 8-14) and the end of the follow-up (6 months)

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Tristan Ferry, MD, PhD	Hôpitaux civils de Lyon	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU Bordeaux		Bordeaux			France
HCL Croix-Rousse

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D003672	Defecation

Ancestor Terms

ID	Term
D004068	Digestive System Physiological Phenomena
D055688	Digestive System and Oral Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided