Clinical trial NCT03350178: Evaluation of Heterologous Fecal microbiotA Transfer in ICU Patients: a FeasibilitY and SafetY StudY
Official title: Evaluation of Heterologous Fecal microbiotA Transfer in ICU Patients: a FeasibilitY and SafetY StudY
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Intensive Care Units
Fecal Microbiota Transplantation
Lead sponsor: MaaT Pharma
Sponsor class: INDUSTRY
First posted: 2017-11-22
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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

Primary outcomes:
measure: Occurrence of FMT-related treatment emergent (serious) adverse events
timeFrame: through study completion, an average of 2 weeks
Secondary outcomes:
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: through study completion, an average of 2 weeks
measure: Occurrence of FMT-related treatment emergent (serious) adverse events as per investigator's opinion
timeFrame: through study completion, an average of 2 weeks
measure: Evaluation of FMT impact on Multi Drug Resistant Bacteria carriage
timeFrame: through study completion, an average of 2 weeks
Other outcomes:
Locations:
city: Lille
country: France
facility: Salengro hospital
city: Paris
country: France
facility: Bichat Hospital
Study officials:
affiliation: CHRU LILLE
name: Anahita Rouze
role: PRINCIPAL_INVESTIGATOR
References: