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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Gram Negative Bacterial Infections

Intervention / Treatment
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* Drug: colistin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: loading dose of colistin<br>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<br>* 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.<br>* Other names: polymyxin e;|
| Active Comparator: without loading dose of colistin<br>Patients will receive 3 million international units of colistin every 8 hours intravenous | Drug: colistin<br>* 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.<br>* Other names: polymyxin e;|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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critically ill patients, colistin dosing, multidrug resistant bacteria