Efficacy of Cefepime Continuous Infusion Versus an Intermittent Dosing Regimen - Full Text View

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

This study has been completed.

First Received: January 24, 2008 Last Updated: February 6, 2008 History of Changes

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
Information provided by:	Javeriana University
ClinicalTrials.gov Identifier:	NCT00609375

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 IV

MedlinePlus related topics: Sepsis

Drug Information available for: Cefepime Cefepime hydrochloride

U.S. FDA Resources

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

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
I: 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.	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.
II: 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	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

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

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

Locations

Colombia, Antioquia
Hospital San Juan de Dios
Rionegro, Antioquia, Colombia
Colombia, DC
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
Colombia, Risaralda
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:	Medicine School, Pontificia Universidad javeriana ( Carlos Arturo Alvarez )
Study ID Numbers:	Universidad Javeriana
Study First Received:	January 24, 2008
Last Updated:	February 6, 2008
ClinicalTrials.gov Identifier:	NCT00609375 History of Changes
Health Authority:	Colombia: Institutional Review Board

Keywords provided by Javeriana University:

Sepsis
Bacteremia
Intravenous infusions
cefepime

Study placed in the following topic categories:

Systemic Inflammatory Response Syndrome
Bacterial Infections
Anti-Bacterial Agents
Sepsis

Cefepime
Critical Illness
Bacteremia
Inflammation

Additional relevant MeSH terms:

Systemic Inflammatory Response Syndrome
Bacterial Infections
Anti-Infective Agents
Anti-Bacterial Agents
Sepsis
Pathologic Processes

Cefepime
Therapeutic Uses
Bacteremia
Infection
Pharmacologic Actions
Inflammation

ClinicalTrials.gov processed this record on May 07, 2009