Prolonged Infusion Cefepime and Nosocomial Infections

• Status: Unknown status
• Trial end date: 2016-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital de Clinicas de Porto Alegre
• Treatments: Cefepime; Cephalosporins

Criteria

Inclusion Criteria:

• Urinary tract infection after 48-72 hours of hospital stay

• Respiratory tract infection after 48-72 hours of hospital stay

• Catheter related urinary tract infection after 48-72 hours of hospital stay

• Urinary or respiratory infections not responding to a narrower spectrum antibiotic

• Isolation of bacteria sensible to cefepime in blood, urine or sputum in a clinical context of infection

Exclusion Criteria:

• Glomerular filtration rate lower than 30 ml.min/1,73m²

• ICU admission for at least 72 hours before randomization

• Neutrophil count lower than 1000 cels per mm³

• Hematologic malignancy, bronchiectasis and cystic fibrosis

• Patients allergic to cefepime

• Concomitant treatment to another infectious disease

• Central nervous system, cutaneous or intrabdominal infections

• Solid organ transplantation

• HIV with a cluster differentiation 4 (CD4) lower than 100 cels per mm³