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

Hospital Barros Luco Trudeau

Status and phase

Unknown

Phase 4

Conditions

Gram Negative Bacterial Infections

Treatments

Drug: colistin

Study type

Interventional

Funder types

Other

Identifiers

NCT02117986

SA13I20317

Details and patient eligibility

About

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.

Full 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.

Enrollment

200 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Exclusion criteria

pregnant or breastfeeding patients
patient with a history of hypersensitivity to colistin

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

200 participants in 2 patient groups

loading dose of colistin

Experimental group

Description:

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

Treatment:

Drug: colistin

without loading dose of colistin

Active Comparator group

Description:

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

Treatment:

Drug: colistin