Efficacy of Cefepime Continuous Infusion Versus an Intermittent Dosing Regimen

Sepsis Clinical Trial

— CEFPK/PD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00609375
• Other study ID #: Universidad Javeriana
• Status: Completed
• Phase: Phase 4
• First received: January 24, 2008
• Last updated: February 6, 2008
• Start date: September 2006
• Est. completion date: December 2007

Study information

• Verified date: January 2008
• Source: Javeriana University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Colombia: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bacteremia
• Sepsis

Intervention

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.
• 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

Locations

Country	Name	City	State
Colombia	Clinica Palermo	Bogota	DC
Colombia	Fundacion San Carlos	Bogota	DC
Colombia	Hospital Santa Clara	Bogota	DC
Colombia	Hospital Simon Bolivar	Bogota	DC
Colombia	Hospital Universitario san Ignacio	Bogota	DC
Colombia	Hospital San Jorge	Pareira	Risaralda
Colombia	Hospital San Juan de Dios	Rionegro	Antioquia

Sponsors (8)

Lead Sponsor	Collaborator
Javeriana University	Asociacion Colombiana de Infectologia, ACIN. Infectious Diseases Society of Colombia, Clinica Palermo, Bogota, Fundación San Carlos, Bogota, Hospital san Jorge, Pereira, Hospital san Juan de Dios, Antioquia, Hospital Santa Clara, Bogota, Hospital Simon Bolivar, Bogota

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate global mortality rate		28 days	No
Secondary	to evaluate clinical and/or microbiologic relapses		28 days	No
Secondary	To evaluate clinical and bacteriological response		3 days	No
Secondary	to evaluate clinical and bacteriological response		7 days	No
Secondary	to evaluate clinical and bacteriological response		14 days	No