Multidrug Resistant Gram Negative Bacterial Infections Clinical Trial
Official title:
Multicentric Study About the Usefulness of Monitoring Plasma Levels of Colistin and Sodium Colistimethate in Patients With Infections Due to Multi-drug Resistant Gram Negative Bacilli, Treated With Colistin.
Objectives: Main objective: to assess the impact of an intervention for optimizing the
dosing of colistin based on its plasma levels in patients with infections due to multi-drug
resistant gram negative bacilli. The impact will be evaluated in terms of clinical and
microbiological outcome, and toxicity.
Secondary objectives:
1. To determine the percentage of patients reaching plasma levels considered adequate
(Cmax / MIC 8-10) for the treatment of infections due to gram-negative bacilli
susceptible to colistin, in the cohort of patients treated with standard doses of this
drug without adjusting the dose.
2. To analyze the possible emergence of bacterial resistance to this drug and its
relationship to the calculated colistin pharmacokinetic and pharmacodynamic indexes.
Methods:
Design: open controlled trial, blinded for the analyst, to be performed at thre tertiary
care Hospitals in Barcelona.
Subjects: Patients attended consecutively between 2012 and 2013 infected with multi-drug
resistant gram negative bacilli and treated with colistin.
Sample size: 142 cases. Intervention: Once detected the infection requiring treatment with
colistin, patients will be randomized to receive the intervention or not, with a 1:1 ratio.
The intervention will be performed by an Infectious Diseases physician and will consist in a
recommendation on the dose of colistin based on its plasma levels 48 hours after treatment
onset.
Variables: peak and through colistin levels 48 hours after treatment onset, clinical,
analytical and microbiological data at baseline and during follow-up of the patients.
Outcome measures: clinical, microbiological and toxicity data. Analysis: Comparison of
patient characteristics and outcome variables between patients who had received the
intervention and those who had not. The analysis will be done by intention to treat, by
biological effectiveness and by compliance with the protocol.
n/a