Intensive Care Units, Fecal Microbiota Transplantation
Conditions
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.
Interventions
transfer of fecal microbiota from healthy donor to the patients
Sponsors
MaaT Pharma
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of FMT-related treatment emergent (serious) adverse events | through study completion, an average of 2 weeks | Occurrence of FMT-related treatment emergent (serious) adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | through study completion, an average of 2 weeks | FMT procedure will be considered as good if it has been accepted without any particular reluctance |
| Occurrence of FMT-related treatment emergent (serious) adverse events as per investigator's opinion | through study completion, an average of 2 weeks | occurrence of FMT-related treatment emergent (serious) adverse events |
| Evaluation of FMT impact on Multi Drug Resistant Bacteria carriage | through study completion, an average of 2 weeks | Based on bacterial culture, description of MDRB carriage. Resistance acquisition or eradication will be evaluated |
Countries
France
Outcome results
None listed