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Evaluation of Heterologous Fecal microbiotA Transfer in ICU Patients: a FeasibilitY and SafetY StudY (HAPY3)

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ClinicalTrials.gov Identifier: NCT03350178
Recruitment Status : Terminated (recruitment shortened)
First Posted : November 22, 2017
Last Update Posted : March 8, 2019
Sponsor:
Information provided by (Responsible Party):
MaaT Pharma

Tracking Information
First Submitted Date  ICMJE November 14, 2017
First Posted Date  ICMJE November 22, 2017
Last Update Posted Date March 8, 2019
Actual Study Start Date  ICMJE January 15, 2018
Actual Primary Completion Date February 19, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 20, 2017)
Occurrence of FMT-related treatment emergent (serious) adverse events [ Time Frame: through study completion, an average of 2 weeks ]
Occurrence of FMT-related treatment emergent (serious) adverse events
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03350178 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 20, 2017)
  • Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: through study completion, an average of 2 weeks ]
    FMT procedure will be considered as good if it has been accepted without any particular reluctance
  • Occurrence of FMT-related treatment emergent (serious) adverse events as per investigator's opinion [ Time Frame: through study completion, an average of 2 weeks ]
    occurrence of FMT-related treatment emergent (serious) adverse events
  • Evaluation of FMT impact on Multi Drug Resistant Bacteria carriage [ Time Frame: through study completion, an average of 2 weeks ]
    Based on bacterial culture, description of MDRB carriage. Resistance acquisition or eradication will be evaluated
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 Evaluation of Heterologous Fecal microbiotA Transfer in ICU Patients: a FeasibilitY and SafetY StudY
Official Title  ICMJE Evaluation of Heterologous Fecal microbiotA Transfer in ICU Patients: a FeasibilitY and SafetY StudY
Brief Summary ICU patient's complications are notably due to multiple infections with high risks of sepsis. Those infections would be worsened by any antibiotic resistance mechanism. Thus, reducing MDR portage in health care unit is a global strategy that will benefit for the patients and the health system organization. Fecal Microbiota transfer and restoration is a promising strategy to achieve this purpose.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Intensive Care Units
  • Fecal Microbiota Transplantation
Intervention  ICMJE Drug: fecal microbiota transfer
transfer of fecal microbiota from healthy donor to the patients
Study Arms  ICMJE Experimental: treated patients
Treated wit FMT
Intervention: Drug: fecal microbiota transfer
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 Terminated
Actual Enrollment  ICMJE
 (submitted: March 6, 2019)
8
Original Estimated Enrollment  ICMJE
 (submitted: November 20, 2017)
10
Actual Study Completion Date  ICMJE February 19, 2019
Actual Primary Completion Date February 19, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age ≥ 18
  • Patients hospitalized in ICU
  • Patients under mechanical ventilation
  • Patients with an expected length of stay of at least 4 days after inclusion
  • Patients identified with an MDRB digestive carriage, determined by a positive rectal swab previously performed during ICU stay, according to usual screening
  • Expected antibiotic (ATB) duration < 10 days
  • Informed written consent from the patient
  • In unconscious patients who are not able to give consent for inclusion in the study, relatives (next-of-kin) give assent on every patient's behalf, and patients will be later given the opportunity to withdraw from the study

Exclusion Criteria:

  • Patients with a high risk of death within 5 days according to investigator's opinion, or subjected to therapeutic limitation decisions
  • Antibiotherapy of more than 4 consecutive days at inclusion
  • Confirmed or suspected intestinal ischemia
  • Confirmed or suspected toxic megacolon or gastrointestinal perforation
  • Any gastro-intestinal bleeding in the past 3 months
  • Any history of abdominal surgery in the past 3 months
  • Any history of chronic digestive disease or gastro-intestinal resection
  • Any counter indication for Trendelenburg position
  • Neutropenia (neutrophil counts < 500 cells/µL)
  • Ongoing immunosuppressive therapy (chemotherapy, any immunosuppressive agents, excluding corticosteroids < 0,5 mg/kg/d of equivalent prednisolone)
  • Enrollment in another trial that may interfere with this study
  • Known allergy or intolerance to trehalose or maltodextrin and latex
  • Pregnancy or breastfeeding
  • Patients with EBV- serology
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 NCT03350178
Other Study ID Numbers  ICMJE MPICU01
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party MaaT Pharma
Study Sponsor  ICMJE MaaT Pharma
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Anahita Rouze CHRU Lille
PRS Account MaaT Pharma
Verification Date March 2019

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