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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 : Recruiting
First Posted : November 22, 2017
Last Update Posted : February 28, 2018
Sponsor:
Information provided by (Responsible Party):
MaaT Pharma

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.

Condition or disease Intervention/treatment Phase
Intensive Care Units Fecal Microbiota Transplantation Drug: fecal microbiota transfer Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Evaluation of Heterologous Fecal microbiotA Transfer in ICU Patients: a FeasibilitY and SafetY StudY
Actual Study Start Date : January 15, 2018
Estimated Primary Completion Date : May 15, 2018
Estimated Study Completion Date : May 15, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

Arm Intervention/treatment
Experimental: treated patients
Treated wit FMT
Drug: fecal microbiota transfer
transfer of fecal microbiota from healthy donor to the patients




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03350178


Contacts
Contact: Corentin Le Camus 0428291403 clecamus@maat-pharma.com
Contact: Benoît Levast 0428291410 blevast@maat-pharma.com

Locations
France
Salengro hospital Recruiting
Lille, France
Contact: Anahita Rouzé, Dr         
Contact: Amélie Cerf         
Principal Investigator: Anahita Rouzé, Dr         
Sub-Investigator: Saad Nseir, Pr         
Bichat Hospital Recruiting
Paris, France, 75018
Contact: Laurence Toffoletti    0140257703    laurence.toffoletti@aphp.fr   
Principal Investigator: Jean François Timsit, Pr         
Sponsors and Collaborators
MaaT Pharma
Investigators
Principal Investigator: Anahita Rouze CHRU Lille

Responsible Party: MaaT Pharma
ClinicalTrials.gov Identifier: NCT03350178     History of Changes
Other Study ID Numbers: MPICU01
First Posted: November 22, 2017    Key Record Dates
Last Update Posted: February 28, 2018
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No