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

Maimónides Biomedical Research Institute of Córdoba

Status and phase

Terminated

Phase 2

Conditions

Carbapenemase-producing Enterobacteriaceae Infection

Treatments

Biological: Fecal microbiota transplantation

Other: Placebo

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT04760665

KAPEDIS

Details and patient eligibility

About

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.

Enrollment

2 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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