NCT02568800

Prolonged Infusion Cefepime and Nosocomial Infections

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 134 (estimated)
• Sponsor: Hospital de Clinicas de Porto Alegre · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Urinary Tract Infection
• Respiratory Tract Infection

Interventions

Type	Name	Description
DRUG	Prolonged Cefepime Infusion	Cefepime infusion should last at least 4 hours with the aide of an infusion bomb
DRUG	Usual Cefepime Infusion	Cefepime infusion occurs directly without the aide of an infusion bomb, lasting roughly thirty minutes

Timeline

• Start date: 2015-10-01
• Primary completion: 2016-03-01
• Completion: 2016-09-01
• First posted: 2015-10-06
• Last updated: 2015-10-16

Locations

1 site across 1 country: Brazil