Impact of Treatment With Colistin on Mortality Bacteremia Multiresistant Acinetobacter Baumannii Sensitive Colistin in Patients Critical

October 8, 2015 updated by: Maimónides Biomedical Research Institute of Córdoba
The present study was designed to study the impact of empirical treatment with colistin empirical monotherapy and combined treatment with tigecycline and vancomycin on mortality of bacteremia Multiresistant Acinetobacter Baumannii . The main objective was to evaluate the efficacy of empirical treatment with colistin and combined targeted therapy. The different therapeutical interventions were administered following the routine clinical practice in the medical centre and the investigator did not assign specific interventions to the subjects of the study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

113

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Critical patients with monomicrobial bloodstream infections due to monoclonal antibodies were studied; specific criteria were applied for analysis of empirical therapy and targeted therapy (113 patients).

Description

Inclusion Criteria:

  • Critics included patients ≥ 16 years with monomicrobial bloodstream infections by multiresistant acinetobacter baumannii to carbapenems and sensitive to colistin accompanied by systemic inflammatory response syndrome, provided they have received targeted treatment with colistin.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
All-cause 30-day mortality (crude).
Time Frame: 30 days
30 days

Secondary Outcome Measures

Outcome Measure
Time Frame
All-cause 14 day mortality (crude).
Time Frame: 14 days
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maimónides Biomedical Research Institute of Córdoba

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

August 28, 2015

First Submitted That Met QC Criteria

October 8, 2015

First Posted (Estimate)

October 9, 2015

Study Record Updates

Last Update Posted (Estimate)

October 9, 2015

Last Update Submitted That Met QC Criteria

October 8, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FCO-COL-2015-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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