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Efficacy of Cefepime Continuous Infusion Versus an Intermittent Dosing Regimen (CEFPK/PD)
This study has been completed.
Study NCT00609375   Information provided by Javeriana University
First Received: January 24, 2008   Last Updated: February 6, 2008   History of Changes

January 24, 2008
February 6, 2008
September 2006
December 2007   (final data collection date for primary outcome measure)
To evaluate global mortality rate [ Time Frame: 28 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00609375 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
 
Efficacy of Cefepime Continuous Infusion Versus an Intermittent Dosing Regimen
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.

 
Phase IV
Interventional
Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study
  • Sepsis
  • Bacteremia
Drug: cefepime
  • Experimental: 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.
  • Active Comparator: 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
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
30
December 2007
December 2007   (final data collection date for primary outcome measure)

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
Both
18 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
Colombia
 
NCT00609375
Carlos Arturo Alvarez, Medicine School, Pontificia Universidad javeriana
Universidad Javeriana
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
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
Javeriana University
January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP