Ignite Creation Date:
2024-05-06 @ 3:48 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04760665
Status:
TERMINATED
Last Update Posted:
2024-07-09
First Post:
2021-02-15
Brief Title:
Clinical Trial to Demonstrate the Effectiveness of Fecal Microbiota Transplantation for Selective Intestinal Decolonization of Patients Colonized by Carbapenemase-producing Klebsiella Pneumoniae
Sponsor:
Maimónides Biomedical Research Institute of Córdoba
Organization:
Maimónides Biomedical Research Institute of Córdoba
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
lack of elegible population
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
KAPEDIS
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None