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

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.

Study Overview

• Status: Terminated
• Conditions: Intensive Care Units; Fecal Microbiota Transplantation
• Intervention / Treatment: Drug: fecal microbiota transfer

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Lille, France
    • Salengro hospital
  • Paris, France, 75018
    • Bichat Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of FMT-related treatment emergent (serious) adverse events	Occurrence of FMT-related treatment emergent (serious) adverse events	through study completion, an average of 2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	FMT procedure will be considered as good if it has been accepted without any particular reluctance	through study completion, an average of 2 weeks
Occurrence of FMT-related treatment emergent (serious) adverse events as per investigator's opinion	occurrence of FMT-related treatment emergent (serious) adverse events	through study completion, an average of 2 weeks
Evaluation of FMT impact on Multi Drug Resistant Bacteria carriage	Based on bacterial culture, description of MDRB carriage. Resistance acquisition or eradication will be evaluated	through study completion, an average of 2 weeks

Collaborators and Investigators

• Sponsor: MaaT Pharma
• Investigators: Principal Investigator: Anahita Rouze, CHRU Lille

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2018
• Primary Completion (Actual): February 19, 2019
• Study Completion (Actual): February 19, 2019

Study Registration Dates

• First Submitted: November 14, 2017
• First Submitted That Met QC Criteria: November 20, 2017
• First Posted (Actual): November 22, 2017

Study Record Updates

• Last Update Posted (Actual): March 8, 2019
• Last Update Submitted That Met QC Criteria: March 6, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: MPICU01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No