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

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ClinicalTrials.gov Identifier: NCT03011502
Recruitment Status : Completed
First Posted : January 5, 2017
Last Update Posted : April 5, 2018
Sponsor:
Information provided by (Responsible Party):
MaaT Pharma

Tracking Information
First Submitted Date  ICMJE December 27, 2016
First Posted Date  ICMJE January 5, 2017
Last Update Posted Date April 5, 2018
Study Start Date  ICMJE December 2016
Actual Primary Completion Date March 27, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 3, 2017)
Evolution of intensity and frequency of Diarrheic Symptoms [ Time Frame: From baseline, up to 15 days after antibiotherapy treatment stop (Week 8 to week 14) ]
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03011502 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 3, 2017)
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) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE InterventiOnal Study of Bone and Joint Infections Related Gut dysbiosIS
Official Title  ICMJE InterventiOnal Study of Bone and Joint Infections Related Gut dysbiosIS
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Condition  ICMJE Bone and Joint Infection
Intervention  ICMJE Other: Biological samples collection of blood and feces
Study Arms  ICMJE Experimental: Experimental arm
Intervention: Other: Biological samples collection of blood and feces
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 14, 2017)
62
Original Estimated Enrollment  ICMJE
 (submitted: January 3, 2017)
100
Actual Study Completion Date  ICMJE March 27, 2018
Actual Primary Completion Date March 27, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03011502
Other Study ID Numbers  ICMJE MPBJI01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party MaaT Pharma
Study Sponsor  ICMJE MaaT Pharma
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Tristan Ferry, MD, PhD Hôpitaux civils de Lyon
PRS Account MaaT Pharma
Verification Date November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP