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

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ClinicalTrials.gov Identifier: NCT02604849
Recruitment Status : Completed
First Posted : November 13, 2015
Last Update Posted : November 13, 2015
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Patients Colonized by Klebsiella Pneumoniae. Drug: Neomycin Drug: Streptomycin Drug: Gentamicins

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Study Type : Observational
Actual Enrollment : 44 participants
Observational Model: Case Control
Time Perspective: Retrospective
Study Start Date : July 2012
Actual Primary Completion Date : July 2015
Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Group/Cohort Intervention/treatment
Received therapy desconolizacion against Klebsiella pneumoniae Drug: Neomycin
Drug: Streptomycin
Drug: Gentamicins
Patients who do not receive the therapy



Primary Outcome Measures :
  1. Mortality for any cause during a six-months period after oral therapy gut decontamination. [ Time Frame: 6 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The sample consists of all patients who received therapy desconolizacion against Klebsiella Pneumoniae versus those not receiving such therapy.
Criteria

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Maimónides Biomedical Research Institute of Córdoba
ClinicalTrials.gov Identifier: NCT02604849     History of Changes
Other Study ID Numbers: FCO-NEE-2015-01
First Posted: November 13, 2015    Key Record Dates
Last Update Posted: November 13, 2015
Last Verified: November 2015
Additional relevant MeSH terms:
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Klebsiella Infections
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Enterobacteriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Gentamicins
Neomycin
Streptomycin
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action