Clinical Trial to Demonstrate the Effectiveness of Fecal Microbiota Transplantation for Selective Intestinal Decolonization of Patients Colonized by Carbapenemase-producing Klebsiella Pneumoniae (KAPEDIS)
Primary Purpose
Carbapenemase-producing Enterobacteriaceae Infection
Status
Recruiting
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Fecal microbiota transplantation
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Carbapenemase-producing Enterobacteriaceae Infection focused on measuring fecal microbiota transplantation, Klebsiella pneumoniae, carbapenemase, intestinal colonization, decolonization
Eligibility Criteria
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
Sites / Locations
- Hospital Universitario Reina SofíaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Fecal microbiota transplantation
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Decolonization
Percentage of patients with intestinal decolonization after receiving oral capsules of FMT or placebo in intention to treat population.
Secondary Outcome Measures
Percentage of patients with adverse effects
Percentage of patients with adverse effects
Bacterial load
Amount of KPC-producing Klebsiella pneumoniae (Kp-KPC) after intervention
Persistent intestinal decolonization
Persistence of intestinal decolonization 90 days after intervention
Infections caused by Kp-KPC
Percentage of patients with infections caused by Kp-KPC after intervention
Mortality
Percentage of patients died after intervention
Full Information
NCT ID
NCT04760665
First Posted
February 15, 2021
Last Updated
March 2, 2023
Sponsor
Maimónides Biomedical Research Institute of Córdoba
Collaborators
Mikrobiomik Healthcare Company S.L.
1. Study Identification
Unique Protocol Identification Number
NCT04760665
Brief Title
Clinical Trial to Demonstrate the Effectiveness of Fecal Microbiota Transplantation for Selective Intestinal Decolonization of Patients Colonized by Carbapenemase-producing Klebsiella Pneumoniae
Acronym
KAPEDIS
Official Title
Randomized, Superiority, Double Blind Controlled With Placebo, Clinical Trial, to Demonstrate the Effectiveness of Fecal Microbiota Transplantation for Selective Intestinal Decolonization of Patients Colonized by Klebsiella Pneumoniae Carbapenemase (KPC)-Producing
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 4, 2021 (Actual)
Primary Completion Date
September 1, 2024 (Anticipated)
Study Completion Date
September 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maimónides Biomedical Research Institute of Córdoba
Collaborators
Mikrobiomik Healthcare Company S.L.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carbapenemase-producing Enterobacteriaceae Infection
Keywords
fecal microbiota transplantation, Klebsiella pneumoniae, carbapenemase, intestinal colonization, decolonization
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Fecal microbiota transplantation
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Biological
Intervention Name(s)
Fecal microbiota transplantation
Intervention Description
Patients will receive four fecal microbiota transplantation (FMT) capsules. Microbiota is obtained from healthy patients.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Patients will receive four oral capsules containing placebo. These capsules will have the same shape, weight and colour as capsules containing FMT.
Primary Outcome Measure Information:
Title
Decolonization
Description
Percentage of patients with intestinal decolonization after receiving oral capsules of FMT or placebo in intention to treat population.
Time Frame
30 days after treatment.
Secondary Outcome Measure Information:
Title
Percentage of patients with adverse effects
Description
Percentage of patients with adverse effects
Time Frame
90 days after treatment.
Title
Bacterial load
Description
Amount of KPC-producing Klebsiella pneumoniae (Kp-KPC) after intervention
Time Frame
7 days and 30 days after treatment.
Title
Persistent intestinal decolonization
Description
Persistence of intestinal decolonization 90 days after intervention
Time Frame
90 days after treatment.
Title
Infections caused by Kp-KPC
Description
Percentage of patients with infections caused by Kp-KPC after intervention
Time Frame
90 days after treatment.
Title
Mortality
Description
Percentage of patients died after intervention
Time Frame
90 days after treatment.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Juan José Castón Osorio, MD
Phone
00 34 671 59 60 70
Email
juanjoco2005@yahoo.es
First Name & Middle Initial & Last Name or Official Title & Degree
Antonio Luque
Phone
(+34) 671 596 070
Email
uicec@imibic.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juan José Castón Osorio, MD
Organizational Affiliation
Hospital Universitario Reina Sofía
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ángela Cano Yuste, MD
Organizational Affiliation
Hospital Universitario Reina Sofía
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitario Reina Sofía
City
Cordoba
ZIP/Postal Code
14004
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juan Jose Caston Osorio, MD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Time Frame
After publishing the results in a journal.
IPD Sharing Access Criteria
Upon request to uicec@imibic.org
Citations:
PubMed Identifier
35387830
Citation
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.
Results Reference
derived
Learn more about this trial
Clinical Trial to Demonstrate the Effectiveness of Fecal Microbiota Transplantation for Selective Intestinal Decolonization of Patients Colonized by Carbapenemase-producing Klebsiella Pneumoniae
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