Urinary Tract Infection Clinical Trial
Official title:
Prolonged Infusion Cefepime and Nosocomial Infections
It is advocated that prolonged infusion of beta-lactamic antibiotics provides better bactericidal effect. The aim of the present study is to randomize patients a to extended cefepime infusion regimen (lasting four hours) or to a usual infusion regimen (not lasting more than thirty minutes) and evaluate the clinical efficacy of this theoretical pharmacokinetic advantage.
Introduction: it has been proved that the main determinant for microbiological cure
gram-negative infections treated with cefepime is the time above minimal inhibitory
concentration (T>MIC). Although this particular pharmacokinetic property have never been
proved in clinical trials utilizing cefepime, intervention studies with other betalactamic
antibiotics, such as pipercillin-tazobactam, showed clinical benefit.
Objective: to evaluate if prolonged infusion (lasting 4 hours) with cefepime translate into
better clinical outcomes.
Methods: the investigators aim to conduct an open-label, unique-centered, randomized
controlled trial using cefepime in prolonged infusions in patients being treated for urinary
or respiratory tract infections. Patients developing these infections after 72 hours of
hospital admission, requiring the use of broader spectrum antibiotics after clinical failure
or isolating gram-negative bacteria from adequate sample sensible to cefepime will be
enrolled. The use of a second antibiotic such as clindamycin, vancomycin or metronidazole
will be allowed.
Interventions: the investigators aim to randomize 134 patients to two different treatment
arms, the intervention arm who will receive the medication in a four hour lasting infusion,
and the active control arm who will receive the medication in a 30 minutes lasting infusion.
The randomization will be conducted in blocks of ten patients each, and it will be balance
according to the patients age (older or younger than 65 years old) and presence of SIRS
criteria.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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