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

This study has been completed.
Sponsor:
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
Information provided by:
Javeriana University
ClinicalTrials.gov Identifier:
NCT00609375
First received: January 24, 2008
Last updated: February 6, 2008
Last verified: January 2008
  Purpose

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.


Condition Intervention Phase
Sepsis
Bacteremia
Drug: cefepime
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Cefepime Continuous Infusion Versus an Intermittent Dosing Regimen in Adult Critically Ill Patients With Gram Negative Bacilli Bacteremia

Resource links provided by NLM:


Further study details as provided by Javeriana University:

Primary Outcome Measures:
  • To evaluate global mortality rate [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • to evaluate clinical and/or microbiologic relapses [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • To evaluate clinical and bacteriological response [ Time Frame: 3 days ] [ Designated as safety issue: No ]
  • to evaluate clinical and bacteriological response [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • to evaluate clinical and bacteriological response [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: September 2006
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 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 Name: Maxipime

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00609375

Locations
Colombia
Hospital San Juan de Dios
Rionegro, Antioquia, Colombia
Hospital Universitario san Ignacio
Bogota, DC, Colombia, 6
Hospital Santa Clara
Bogota, DC, Colombia, 6
Clinica Palermo
Bogota, DC, Colombia, 6
Fundacion San Carlos
Bogota, DC, Colombia, 6
Hospital Simon Bolivar
Bogota, DC, Colombia, 6
Hospital San Jorge
Pareira, Risaralda, Colombia
Sponsors and Collaborators
Javeriana University
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
  More Information

No publications provided

Responsible Party: Carlos Arturo Alvarez, Medicine School, Pontificia Universidad javeriana
ClinicalTrials.gov Identifier: NCT00609375     History of Changes
Other Study ID Numbers: Universidad Javeriana
Study First Received: January 24, 2008
Last Updated: February 6, 2008
Health Authority: Colombia: Institutional Review Board

Keywords provided by Javeriana University:
Sepsis
Bacteremia
Intravenous infusions
cefepime

Additional relevant MeSH terms:
Bacteremia
Sepsis
Bacterial Infections
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Cefepime
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 21, 2014