Status:
COMPLETED
Fecal Microbiota Transplantation for Carbapenem Resistant Enterobacteriaceae
Lead Sponsor:
Rambam Health Care Campus
Conditions:
Carbapenem-Resistant Enterobacteriaceae Infection
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
PHASE3
Brief Summary
Open-label, single center, prospective interventional non-comparative study for CRE carriers.
Detailed Description
Antibiotic resistance has emerged worldwide and is of major concern leading to multidrug resistant (MDR) bacteria that are widely spread and are a major factor in morbidity and mortality in health-car...
Eligibility Criteria
Inclusion
- We will include adult inpatients ≥18 years positive for CRE of any strain and resistance mechanism in rectal surveillance stool samples, with or without CRE clinical samples. We will mandate a positive rectal swab within one week before randomization. Several exclusion criteria may change throughout the patients' hospitalization and we will follow-up patients for these criteria until reaching eligibility or not (designed as (for follow-up)). Non-eligible patients discharged will be re-evaluated for inclusion when re-admitted.
Exclusion
- Pregnant women Patients with severe neutropenia (\<100/µl) (for follow-up) Severe GVHD involving the gastrointestinal involvment (for follow-up) Patients with inflammatory bowel disease (Crohn's or ulcerative colitis) Patients with intestinal perforation or severe abdominal infection (for follow-up) Patients carrying a colostomy, ileostomy or similar Inability or contra-indication to take oral medications (intestinal obstruction, suspected perforation, peritonitis) (for follow-up) Severe food allergies Severe diarrhea (for follow-up) Inability to provide informed consent (for follow-up) Refusal of primary care physician Patients treated with antibiotics within the 2 days before fulfilling all other eligibility criteria (for follow-up)
Key Trial Info
Start Date :
April 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2022
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04790565
Start Date
April 1 2021
End Date
October 1 2022
Last Update
October 26 2022
Active Locations (1)
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1
Rambam Health Care Campus
Haifa, Israel