Prevention and Decolonization of Multidrug-resistant Bacteria With Probiotics (NCT03967301) | Clinical Trial Compass
UnknownNot Applicable
Prevention and Decolonization of Multidrug-resistant Bacteria With Probiotics
228 participantsStarted 2019-10
Plain-language summary
This study explores the effect of probiotic administration to decrease colonization by Carbapenem resistant Enterobacteriaceae (CRE) in at-risk populations. Colonized patients will be randomized to receive probiotics or placebo for 14 days and reevaluated for colonization in follow up.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* CRE- colonized patients
* adult patients in hospital (over 18 years old)
* Part of the HIBA health care plan
* CRE positive rectal swab or stool in the last 14 days
Exclusion criteria:
* Enteral route enabled (oral, nasogastric tube, gastrostomy or jejunostomy)
* Refusal to participate in the study
* Not available for weekly checks, minimum up to 12 weeks from enrollment
* Clostridium difficile active infection concomitant with CRE swab in a 14-day period days
* Neutropenia G3 or greater (less than 1000 neutrophils at the time of enrollment).
* Severe immunosuppressed at the time of recruitment according to the CDC definition (patients transplanted, HIV with CD4 \<200, congenital immunodeficiencies, leukemias, lymphomas, cancer disseminated, current chemotherapy or radiotherapy, treatment with corticoids high dose:prednisone 20 mg / d\> 2 weeks or immunosuppressive drugs).
* Patient with valvular prostheses
* Imminent death
* Fistula or dehiscence of the gastrointestinal tract
* Acute pancreatitis
* Patient of critical units in ileus and / or with high requirement of vasopressors (noradrenaline equal to or greater than 0.5 gammas) at the time of recruitment
What they're measuring
1
presence of CRE in anal swab or stool culture in follow-up control: