Carbapenemase-producing Enterobacteriaceae Infection
Conditions
Keywords
fecal microbiota transplantation, Klebsiella pneumoniae, carbapenemase, intestinal colonization, decolonization
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.
Interventions
BIOLOGICALFecal microbiota transplantation
Patients will receive four fecal microbiota transplantation (FMT) capsules. Microbiota is obtained from healthy patients.
OTHERPlacebo
Patients will receive four oral capsules containing placebo. These capsules will have the same shape, weight and colour as capsules containing FMT.
Sponsors
Mikrobiomik Healthcare Company S.L.
Maimónides Biomedical Research Institute of Córdoba
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Decolonization | 30 days after treatment. | Percentage of patients with intestinal decolonization after receiving oral capsules of FMT or placebo in intention to treat population. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients with adverse effects | 90 days after treatment. | Percentage of patients with adverse effects |
| Bacterial load | 7 days and 30 days after treatment. | Amount of KPC-producing Klebsiella pneumoniae (Kp-KPC) after intervention |
| Persistent intestinal decolonization | 90 days after treatment. | Persistence of intestinal decolonization 90 days after intervention |
| Infections caused by Kp-KPC | 90 days after treatment. | Percentage of patients with infections caused by Kp-KPC after intervention |
| Mortality | 90 days after treatment. | Percentage of patients died after intervention |
Countries
Spain
Outcome results
None listed