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

NCT03350178 | Terminated Phase 2

• 1 other identifier: MPICU01
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 2

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.

Conditions

Intensive Care Units; Fecal Microbiota Transplantation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  through study completion, an average of 2 weeks

• Occurrence of FMT-related treatment emergent (serious) adverse events as per investigator's opinion

  through study completion, an average of 2 weeks

• Evaluation of FMT impact on Multi Drug Resistant Bacteria carriage

  through study completion, an average of 2 weeks

Study Arms (1)

treated patients

EXPERIMENTAL

Treated wit FMT

Drug: fecal microbiota transfer

Interventions

fecal microbiota transfer DRUG

transfer of fecal microbiota from healthy donor to the patients

treated patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18
• Patients hospitalized in ICU
• Patients under mechanical ventilation
• 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

You may not qualify if:

• Patients with a high risk of death within 5 days according to investigator's opinion, or subjected to therapeutic limitation decisions
• 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

Sponsors & Collaborators

• MaaT Pharma: lead

Study Sites (2)

Salengro hospital

Lille, France

Location

Bichat Hospital

Paris, 75018, France

Location

MeSH Terms

Interventions

Fecal Microbiota Transplantation

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Anahita Rouze

  CHRU LILLE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2017
• First Posted: November 22, 2017
• Study Start: January 15, 2018
• Primary Completion: February 19, 2019
• Study Completion: February 19, 2019
• Last Updated: March 8, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)