Efficacy of Cefepime Continuous Infusion Versus an Intermittent Dosing Regimen

Summary

To determine the efficacy of the administration of 7 to 14 days of cefepime in a continuous infusion vs an intermittent (every 8 hours) administration, in adult patients hospitalized in Bogotá with sepsis and bacteremia caused by gram negative bacilli. The outcome was the rate of clinical cure and microbiological cure after 7 and 14 days of initiation of therapy and rates of relapse after 28 days.

Hypothesis: The administration of beta lactams in continuous infusion allows a clinical or microbiological cure greater than the intermittent administration.

Conditions

• Sepsis
• Bacteremia

Interventions

DRUG

cefepime

Administration of cefepime in continuous infusion (3 Gr over 24 hours) for 7-14 days at the discretion of the investigator. Administration of saline solution 0.9%, 50-100 mL over 30 minutes every 8 hours.

DRUG

cefepime

Administration of cefepime in intermittent infusion (1 Gr over 30 minutes every 8 hours) for 7-14 days at the discretion of the investigator.Administration of saline solution 0.9%, 50-250 mL over 24 hours

Sponsors & Collaborators

• Asociacion Colombiana de Infectologia, ACIN. Infectious Diseases Society of Colombia

  collaborator UNKNOWN

• Hospital Simon Bolivar, Bogota

  collaborator UNKNOWN

• Clinica Palermo, Bogota

  collaborator UNKNOWN

• Hospital Santa Clara, Bogota

  collaborator UNKNOWN

• Fundación San Carlos, Bogota

  collaborator UNKNOWN

• Hospital san Juan de Dios, Antioquia

  collaborator UNKNOWN

• Hospital san Jorge, Pereira

  collaborator UNKNOWN

• Javeriana University

  lead OTHER

Principal Investigators

• carlos A Alvarez, MD · Pontificia Universidad Javeriana

• Alvaro Ruiz, MD; MSc · Pontificia Universidad Javeriana

• Fabian GIL, Msc · Pontificia Universidad Javeriana

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

90 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2006-09-30

Primary Completion

2007-12-31

Completion

2007-12-31

Countries

• Colombia

Study Locations