Efficacy of Cefepime Continuous Infusion Versus an Intermittent Dosing Regimen (CEFPK/PD)

Efficacy of Cefepime Continuous Infusion Versus an Intermittent Dosing Regimen in Adult Critically Ill Patients With Gram Negative Bacilli Bacteremia

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.

Study Overview

• Status: Completed
• Conditions: Sepsis; Bacteremia
• Intervention / Treatment: Drug: cefepime; Drug: cefepime

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 4

Contacts and Locations

Study Locations

• Colombia
  • Antioquia
    • Rionegro, Antioquia, Colombia
      • Hospital San Juan de Dios
  • DC
    • Bogota, DC, Colombia, 6
      • Clínica Palermo
    • Bogota, DC, Colombia, 6
      • Fundacion San Carlos
    • Bogota, DC, Colombia, 6
      • Hospital Santa Clara
    • Bogota, DC, Colombia, 6
      • Hospital Simon Bolivar
    • Bogota, DC, Colombia, 6
      • Hospital Universitario San Ignacio
  • Risaralda
    • Pareira, Risaralda, Colombia
      • Hospital San Jorge

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with sepsis, severe sepsis o septic shock diagnosis hospitalized in Intensive care Unit.
• Presence or suspect of Gram negative bacilli bacteremia
• To be possible the follow up according to planned visits
• Patients should be venous access to administrate the antibiotic
• Patients, whom the physicians consider cefepime like election treatment

Exclusion Criteria:

• Patients with a high degree of immunosuppression defined by:

  • The presence of neutropenia (Neutrophils count less than 500 cells/mL, or Infection with HIV-AIDS with count of less than 50 CD4 cells/mL, or chronic Administration of immunosuppressive drugs (prednisone more than 5 mg/per day, azathioprine, cyclophosphamide, mycophenolate mofetil, etc.)
• Patients with chronic renal failure.
• Pregnant female patients
• Patients in whom to approach the doctor is considered with a high probability of dying in the next 48 hours (e.g. multiorgan system failure with more than 5 organs engaged according to the criteria of MarshalL et al. or shock irreversible.
• Patients with chronic infections as osteomyelitis or have prosthesis that would perpetuate the infection and requiring the administration of antibiotics for an extended time (including Endocarditis). -Patients with mixed infections that include Gram positive microorganisms or fungal infections.
• -Patients who have received in the past 30 days cefepime.
• Patients with presence of a gram negative bacillus resistant to cefepime. -Patients who are not able to identify them a bacillus gram negative.
• Patients who they are not able to confirm the antibiotic susceptibility of gram negative bacillus. -Patients with concomitant with antimicrobial activity for Gram negative bacilli (e.g. fluoroquinolones, aminoglycosides, etc.)
• Patients who have known hypersensitivity to B lactams or cefepime

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: I; Administration of cefepime in continuous infusion (3 Gr over 24 hours) for at least 7 days and no more than 14 days 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 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.; Other Names: maxipime; 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; Other Names: Maxipime
Active Comparator: II; Administration of cefepime in intermittent infusion (1 Gr over 30 minutes every 8 hours) for at least 7 days and no more than 14 days days at the discretion of the investigator.Administration of saline solution 0.9%, 50-250 mL over 24 hours	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.; Other Names: maxipime; 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; Other Names: Maxipime

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To evaluate global mortality rate	28 days

Secondary Outcome Measures

Outcome Measure	Time Frame
to evaluate clinical and/or microbiologic relapses	28 days
To evaluate clinical and bacteriological response	3 days
to evaluate clinical and bacteriological response	7 days
to evaluate clinical and bacteriological response	14 days

Collaborators and Investigators

• Sponsor: Javeriana University
• Collaborators: Asociacion Colombiana de Infectologia, ACIN. Infectious Diseases Society of Colombia; Hospital Simon Bolivar, Bogota; Clinica Palermo, Bogota; Hospital Santa Clara, Bogota; Fundación San Carlos, Bogota; Hospital san Juan de Dios, Antioquia; Hospital san Jorge, Pereira
• Investigators: Principal Investigator: carlos A Alvarez, MD, Pontificia Universidad Javeriana; Study Chair: Alvaro Ruiz, MD; MSc, Pontificia Universidad Javeriana; Study Chair: Fabian GIL, Msc, Pontificia Universidad Javeriana

Study record dates

Study Major Dates

• Study Start: September 1, 2006
• Primary Completion (Actual): December 1, 2007
• Study Completion (Actual): December 1, 2007

Study Registration Dates

• First Submitted: January 24, 2008
• First Submitted That Met QC Criteria: February 6, 2008
• First Posted (Estimate): February 7, 2008

Study Record Updates

• Last Update Posted (Estimate): February 7, 2008
• Last Update Submitted That Met QC Criteria: February 6, 2008
• Last Verified: January 1, 2008

More Information

Terms related to this study

• Keywords: Bacteremia; Sepsis; cefepime; Intravenous infusions
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Bacterial Infections; Bacterial Infections and Mycoses; Sepsis; Bacteremia; Anti-Infective Agents; Anti-Bacterial Agents; Cefepime
• Other Study ID Numbers: Universidad Javeriana