Efficacy and Mortality of a Loading Dose of Colistin in Critical Ill Patients
- Registration Number
- NCT02117986
- Lead Sponsor
- Hospital Barros Luco Trudeau
- 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.
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 200
- 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
- pregnant or breastfeeding patients
- patient with a history of hypersensitivity to colistin
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description without loading dose of colistin colistin Patients will receive 3 million international units of colistin every 8 hours intravenous loading dose of colistin 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
- Primary Outcome Measures
Name Time Method 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
Percentage of patients with clinical response to treatment up to 1 week remission or reduction of clinical signs of infection
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Hospital Barros Luco Trudeau
🇨🇱Santiago, Region Metropolitana, Chile
Hospital de Puerto Montt
🇨🇱Puerto Montt, Chile