Status:
TERMINATED
Clinical Trial to Demonstrate the Effectiveness of Fecal Microbiota Transplantation for Selective Intestinal Decolonization of Patients Colonized by Carbapenemase-producing Klebsiella Pneumoniae
Lead Sponsor:
Maimónides Biomedical Research Institute of Córdoba
Collaborating Sponsors:
Mikrobiomik Healthcare Company S.L.
Conditions:
Carbapenemase-producing Enterobacteriaceae Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Infections caused by carbapenemase-producing Enterobacteriaceae are frequent and often associated with high rates of mortality. Colonized patients are at increased risk of infection for these microorg...
Eligibility Criteria
Inclusion
- Age\> = 18 years.
- Signature of the informed consent by the patient or legally designated person
- Absence of active infection by carbapenemase-type KPC-producing Klebsiella pneumoniae at the time of assessment as well as in the month prior to inclusion in the study
Exclusion
- Terminal situation, or estimated life expectancy of less than 3 months
- Pregnant or lactating women
- Intolerance or inability to take oral medication at the time of assessment
- History of aspiration or dysphagia
- Patients with a history of colectomy, colostomy or ileostomy
- Patients who are receiving or have received antibiotics in the month prior to the inclusion assessment
- Neutrophil count less than 500 cells / mm3
- Anticipation of the use of myelosuppressive treatment (eg. dexamethasone, chemotherapy against to solid tumors or prior to transplantation of hematopoietic progenitories) within 30 days after inclusion in the study
- Hematopoietic stem cell transplantation in the month prior to inclusion in the study
- Presence of clinical signs of mucositis
- Forecast of major abdominal surgical intervention in the month following inclusion in the study
- Patients with a Gianella Score\> 12 points
- History of having received decolonization guidelines in the previous 3 months
- Severe food allergy
Key Trial Info
Start Date :
October 4 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 24 2023
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT04760665
Start Date
October 4 2021
End Date
November 24 2023
Last Update
July 9 2024
Active Locations (1)
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1
Hospital Universitario Reina Sofía
Córdoba, Spain, 14004