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

NCT04760665 | Terminated Phase 2

• 1 other identifier: KAPEDIS
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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 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

Keywords

fecal microbiota transplantation; Klebsiella pneumoniae; carbapenemase; intestinal colonization; decolonization

Outcome Measures

Primary Outcomes (1)

• Decolonization

  Percentage of patients with intestinal decolonization after receiving oral capsules of FMT or placebo in intention to treat population.

  30 days after treatment.

Secondary Outcomes (5)

• Percentage of patients with adverse effects

  90 days after treatment.

• Bacterial load

  7 days and 30 days after treatment.

• Persistent intestinal decolonization

  90 days after treatment.

• Infections caused by Kp-KPC

  90 days after treatment.

• Mortality

  90 days after treatment.

Study Arms (2)

Fecal microbiota transplantation

EXPERIMENTAL

Biological: Fecal microbiota transplantation

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

Fecal microbiota transplantation BIOLOGICAL

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

Fecal microbiota transplantation

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age\> = 18 years.
• Signature of the informed consent by the patient or legally designated person

You may not qualify if:

• 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
• Neutrophil count less than 500 cells / mm3
• Presence of clinical signs of mucositis
• Patients with a Gianella Score\> 12 points
• History of having received decolonization guidelines in the previous 3 months
• Severe food allergy

Sponsors & Collaborators

• Maimónides Biomedical Research Institute of Córdoba: lead
• Mikrobiomik Healthcare Company S.L.: collaborator

Study Sites (1)

Hospital Universitario Reina Sofía

Córdoba, 14004, Spain

Location

Related Publications (1)

• Perez-Nadales E, Cano A, Recio M, Artacho MJ, Guzman-Puche J, Doblas A, Vidal E, Natera C, Martinez-Martinez L, Torre-Cisneros J, Caston JJ. Randomised, double-blind, placebo-controlled, phase 2, superiority trial to demonstrate the effectiveness of faecal microbiota transplantation for selective intestinal decolonisation of patients colonised by carbapenemase-producing Klebsiella pneumoniae (KAPEDIS). BMJ Open. 2022 Apr 6;12(4):e058124. doi: 10.1136/bmjopen-2021-058124.

  PMID: 35387830 DERIVED

MeSH Terms

Interventions

Fecal Microbiota Transplantation

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Juan José Castón Osorio, MD

  Hospital Universitario Reina Sofía

  PRINCIPAL INVESTIGATOR

• Ángela Cano Yuste, MD

  Hospital Universitario Reina Sofía

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2021
• First Posted: February 18, 2021
• Study Start: October 4, 2021
• Primary Completion: November 24, 2023
• Study Completion: November 24, 2023
• Last Updated: July 9, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: After publishing the results in a journal.
• Access Criteria: Upon request to uicec@imibic.org

Locations

ES (1)