Efficacy and Mortality of a Loading Dose of Colistin in Critical Ill Patients

Sponsor

Hospital Barros Luco Trudeau (Other)

Overall Status

Unknown status

CT.gov ID

NCT02117986

Collaborator

Fondo Nacional de Desarrollo Científico y Tecnológico, Chile (Other)

200

Enrollment

Locations

Arms

Duration (Months)

100

Patients Per Site

1.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study hypothesis is that the loading dose of intravenous colistin (6 million of international units) is associated with greater clinical and microbiological efficacy, and reduced mortality of critically ill patients infected by multidrug resistant Gram- negative bacilli, compared to a scheme without loading dose.

Condition or Disease	Intervention/Treatment	Phase
Gram Negative Bacterial Infections	Drug: colistin	Phase 4

Detailed Description

It is a prospective, multicenter, randomized, controlled study to evaluate a scheme with and without a loading dose of 6 million international units of colistin, followed by a maintenance dose of 3 million international units every 8 hours intravenous. The study should be conducted in 3 hospitals in Chile, in critically patients presenting infection by multidrug Gram-negative bacteria and requiring be treated with colistin for at least 48 hours. The objectives of the study are: to evaluate the clinical and microbiological response, and mortality.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Clinical and Microbiological Efficacy and Mortality of a Loading Dose of Colistin in Critical Ill Patients

Study Start Date :

Apr 1, 2014

Anticipated Primary Completion Date :

Dec 1, 2018

Anticipated Study Completion Date :

Dec 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: loading dose of colistin Patients will receive a loading dose of colistin (6 million international units) followed by a maintenance dose of 3 million international units of colistin every 8 hours intravenous	Drug: colistin One arm will receive a loading dose of colistin (6 million international units), and a maintenance dose of 3 million every 8 hours. The other arm will receive a maintenance dose of 3 million international units every 8 hours. Other Names: colistimethate sodium polymyxin e
Active Comparator: without loading dose of colistin Patients will receive 3 million international units of colistin every 8 hours intravenous	Drug: colistin One arm will receive a loading dose of colistin (6 million international units), and a maintenance dose of 3 million every 8 hours. The other arm will receive a maintenance dose of 3 million international units every 8 hours. Other Names: colistimethate sodium polymyxin e

Arm

Intervention/Treatment

Experimental: loading dose of colistin

Patients will receive a loading dose of colistin (6 million international units) followed by a maintenance dose of 3 million international units of colistin every 8 hours intravenous

Drug: colistin

One arm will receive a loading dose of colistin (6 million international units), and a maintenance dose of 3 million every 8 hours. The other arm will receive a maintenance dose of 3 million international units every 8 hours.

Other Names:

colistimethate sodium

polymyxin e

Active Comparator: without loading dose of colistin

Patients will receive 3 million international units of colistin every 8 hours intravenous

Drug: colistin

Other Names:

colistimethate sodium

polymyxin e

Outcome Measures

Primary Outcome Measures

Percentage of patients with clinical response to treatment [up to 1 week]
remission or reduction of clinical signs of infection
percentage of patients with microbiological response [up to 1 week]
negative culture at the same site where the positive culture was obtained before
mortality [during their stay in the intensive care unit]
the mortality during their stay in the intensive care unit, an expected average of 4 weeks

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

patient hospitalized in critical care units
patient infected by multi drug resistant Gram negative bacteria susceptibly only to colistin
source of infection: blood, respiratory, intra abdominal or urinary