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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02604849
Enrollment
44
Registered
2015-11-13
Start date
2012-07-31
Completion date
2015-11-30
Last updated
2015-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients Colonized by Klebsiella Pneumoniae.

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.

Interventions

Sponsors

Maimónides Biomedical Research Institute of Córdoba
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Mortality for any cause during a six-months period after oral therapy gut decontamination.6 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 12, 2026