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OpenTrials
Completed

NCT Number: NCT02604849

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

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.

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Key information

Conditions

Patients Colonized by Klebsiella Pneumoniae.

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Neomycin

Drug

Streptomycin

Drug

Gentamicins

Drug

Primary outcomes

  1. Mortality for any cause during a six-months period after oral therapy gut decontamination.

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Maimónides Biomedical Research Institute of Córdoba

Other

Registry information

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Nov 13, 2015
Registry last updated
Nov 13, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.