Status:
TERMINATED
Evaluation of Heterologous Fecal microbiotA Transfer in ICU Patients: a FeasibilitY and SafetY StudY
Lead Sponsor:
MaaT Pharma
Conditions:
Intensive Care Units
Fecal Microbiota Transplantation
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 h...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 19 2019
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT03350178
Start Date
January 15 2018
End Date
February 19 2019
Last Update
March 8 2019
Active Locations (2)
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1
Salengro hospital
Lille, France
2
Bichat Hospital
Paris, France, 75018