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

NCT ID: NCT02604849

Last Updated: 2015-11-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 44 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2015-11-30

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.

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

Received therapy desconolizacion against Klebsiella pneumoniae

Neomycin

Intervention Type: DRUG

Streptomycin

Intervention Type: DRUG

Gentamicins

Intervention Type: DRUG

Patients who do not receive the therapy

No interventions assigned to this group

Interventions

Neomycin

Intervention Type: DRUG

Streptomycin

Intervention Type: DRUG

Gentamicins

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Maimónides Biomedical Research Institute of Córdoba

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

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.

Reference Type: DERIVED

PMID: 27494911 (View on PubMed)

Other Identifiers

FCO-NEE-2015-01

Identifier Type: -

Identifier Source: org_study_id