Clinical Trial to Demonstrate the Effectiveness of Fecal Microbiota Transplantation for Selective… (NCT04760665) | Clinical Trial Compass
TerminatedPhase 2
Clinical Trial to Demonstrate the Effectiveness of Fecal Microbiota Transplantation for Selective Intestinal Decolonization of Patients Colonized by Carbapenemase-producing Klebsiella Pneumoniae
Stopped: lack of elegible population
Spain2 participantsStarted 2021-10-04
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Decolonization
Timeframe: 30 days after treatment.
Trial details
NCT IDNCT04760665
SponsorMaimónides Biomedical Research Institute of Córdoba