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Clinical Trial to Demonstrate the Effectiveness of Fecal Microbiota Transplantation for Selective Intestinal Decolonization of Patients Colonized by Carbapenemase-producing Klebsiella Pneumoniae

NCT04760665 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2024-07-09

No results posted yet for this study

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 microorganisms. Moreover, they can act as a reservoir facilitating the transmission to other patients. To date, decolonization strategies with antibiotics have not obtained convincing results. For that reason our main objective is to investigate the efficacy of fecal microbiota transplantation (FMT) for selective intestinal decolonization of patients colonized by KPC-producing Klebsiella pneumoniae (Kp-KPC) at 30 days after FMT. Our hypothesis is that FMT is effective and safe for selective intestinal decolonization in patients colonized by Kp-KPC. The design of the study is a randomized, superiority, double blind controlled with placebo clinical trial.

The main variable is the percentage of patients with intestinal decolonization at 30 days after FMT in intention to treat population (all randomized patients). Decolonization will be considered as the abscence of isolation of Kp-KPC in culture from rectal swab together with the abscence of detection of carbapenemase by mean of polymerase chain reaction.

Secondary objectives are:

* To evaluate the safety of FMT.
* To determine if FMT is associated with decrease in the amount of bacteria at 7 days after FMT and 30 days after FMT.
* To evaluate if FMT is associated with persistent intestinal decolonization at 3 months after intervention.
* To study if FMT is associated with decrease in the incidence of Kp-KPC infections at 3 months after intervention.
* To evaluate if FMT is associated with decrease in mortality due to Kp-KPC infections at 3 months after intervention.

Conditions

  • Carbapenemase-producing Enterobacteriaceae Infection

Interventions

BIOLOGICAL

Fecal microbiota transplantation

Patients will receive four fecal microbiota transplantation (FMT) capsules. Microbiota is obtained from healthy patients.

OTHER

Placebo

Patients will receive four oral capsules containing placebo. These capsules will have the same shape, weight and colour as capsules containing FMT.

Sponsors & Collaborators

  • Mikrobiomik Healthcare Company S.L.

    collaborator INDUSTRY

  • Maimónides Biomedical Research Institute of Córdoba

    lead OTHER

Principal Investigators

  • Juan José Castón Osorio, MD · Hospital Universitario Reina Sofía

  • Ángela Cano Yuste, MD · Hospital Universitario Reina Sofía

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-04
Primary Completion
2023-11-24
Completion
2023-11-24

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04760665 on ClinicalTrials.gov