Prolonged Infusion Cefepime and Nosocomial Infections

NCT ID: NCT02568800

Last Updated: 2015-10-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 134 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2016-09-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Prolonged Cefepime Infusion

Cefepime infusions should last 4 hours at least

Group Type: EXPERIMENTAL

Prolonged Cefepime Infusion

Intervention Type: DRUG

Cefepime infusion should last at least 4 hours with the aide of an infusion bomb

Usual Cefepime Infusion

Cefepime infusion should last no more than 30 minutes

Group Type: ACTIVE_COMPARATOR

Usual Cefepime Infusion

Intervention Type: DRUG

Cefepime infusion occurs directly without the aide of an infusion bomb, lasting roughly thirty minutes

Interventions

Prolonged Cefepime Infusion

Cefepime infusion should last at least 4 hours with the aide of an infusion bomb

Intervention Type: DRUG

Usual Cefepime Infusion

Cefepime infusion occurs directly without the aide of an infusion bomb, lasting roughly thirty minutes

Intervention Type: DRUG

Other Intervention Names

Estended Cefepime Infusion; Regular Cefepime Infusion

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eduardo Sprinz

Role: PRINCIPAL_INVESTIGATOR

Hospita de Clínicas de Porto Alegre

Locations

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

André Dias Américo

Role: CONTACT

adamerico@hcpa.edu.br

+555193112207

Facility Contacts

André Dias Américo

Role: primary

adamerico@hcpa.edu.br

+555133598152

Other Identifiers

15-0392

Identifier Type: -

Identifier Source: org_study_id