Efficacy of Intestinal Decontamination in Patients Colonized by Carbapenem-resistant Klebsiella Pneumoniae and Colistin

Completed

• Conditions: Patients Colonized by Klebsiella Pneumoniae.
• Interventions: Drug: Neomycin; Drug: Streptomycin; Drug: Gentamicins

• Registration Number: NCT02604849
• Lead Sponsor: Maimónides Biomedical Research Institute of Córdoba

Brief Summary

The identification of all cases (44 patients) was carried out from the database of microbiology, University Hospital Reina Sofía and the University Hospital of Jerez. For the identification of controls, in case of neutropenic patients, all colonized patients that were included during the study period did not receive any decolonitation treatment; in case of non-neutropenic patients it was studied a paired control by the presence of risk factors that indicated the beginning of decolonitation treatment.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07
• Primary Completion: 2015-07
• Status Verified: 2015-11
• Study Completion: 2015-11
• Study First Submitted: 2015-11-10
• Study First Submitted QC: 2015-11-12
• Last Update Submitted: 2015-11-12
• Study First Posted: 2015-11-13
• Last Update Posted: 2015-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

• Patients with intestinal colonization by Klebsiella pneumoniae, defined as the presence of a positive rectal swab culture at least 7 days prior to initiation of therapy; and patients considered at risk of developing an invasive infection by Klebsiella pneumoniae:
• Surgery in two weeks
• Transplant in two weeks
• Require medical intervention or has a clinical situation that may predispose to the development of a serious infection (chemotherapy, immunosuppression or neutropenia)
• Recurrent or severe infections
• Institution admission
• Fragile patients at high risk of readmission.

Exclusion Criteria

• The presence of an active infection for Klebsiella Pneumoniae.
• Concomitant use of systemic antibiotics in the 14 days before the start of decolonization therapy.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Received therapy desconolizacion against Klebsiella pneumoniae	Gentamicins	-
Received therapy desconolizacion against Klebsiella pneumoniae	Neomycin	-
Received therapy desconolizacion against Klebsiella pneumoniae	Streptomycin	-

Primary Outcome Measures

Name	Time	Method
Mortality for any cause during a six-months period after oral therapy gut decontamination.	6 months