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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
200
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.
Hospital Barros Luco Trudeau
Santiago, Santiago Metropolitan, Chile
RECRUITINGHospital de Puerto Montt
Port Montt, Chile
RECRUITINGPercentage of patients with clinical response to treatment
remission or reduction of clinical signs of infection
Time frame: up to 1 week
percentage of patients with microbiological response
negative culture at the same site where the positive culture was obtained before
Time frame: up to 1 week
mortality
the mortality during their stay in the intensive care unit, an expected average of 4 weeks
Time frame: during their stay in the intensive care unit
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