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

NCT02604849 | Completed

• 1 other identifier: FCO-NEE-2015-01
• Study Type: observational
• Target: 44
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Patients Colonized by Klebsiella Pneumoniae.

Outcome Measures

Primary Outcomes (1)

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

  6 months

Study Arms (2)

Received therapy desconolizacion against Klebsiella pneumoniae

Drug: Neomycin; Drug: Streptomycin; Drug: Gentamicins

Patients who do not receive the therapy

Interventions

Neomycin DRUG

Received therapy desconolizacion against Klebsiella pneumoniae

Streptomycin DRUG

Received therapy desconolizacion against Klebsiella pneumoniae

Gentamicins DRUG

Received therapy desconolizacion against Klebsiella pneumoniae

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Maimónides Biomedical Research Institute of Córdoba: lead

Related Publications (1)

• Machuca I, Gutierrez-Gutierrez B, Perez Cortes S, Gracia-Ahufinger I, Serrano J, Madrigal MD, Barcala J, Rodriguez-Lopez F, Rodriguez-Bano J, Torre-Cisneros J. Oral decontamination with aminoglycosides is associated with lower risk of mortality and infections in high-risk patients colonized with colistin-resistant, KPC-producing Klebsiella pneumoniae. J Antimicrob Chemother. 2016 Nov;71(11):3242-3249. doi: 10.1093/jac/dkw272. Epub 2016 Jul 26.

  PMID: 27494911 DERIVED

MeSH Terms

Interventions

Neomycin; Streptomycin; Gentamicins

Intervention Hierarchy (Ancestors)

Aminoglycosides; Glycosides; Carbohydrates

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2015
• First Posted: November 13, 2015
• Study Start: July 1, 2012
• Primary Completion: July 1, 2015
• Study Completion: November 1, 2015
• Last Updated: November 13, 2015

Record last verified: 2015-11