Efficacy of Cefepime Continuous Infusion Versus an Intermittent Dosing Regimen

• Status: Completed
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Javeriana University
• Collaborators: 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
• Treatments: Cefepime; Cephalosporins; Pharmaceutical Solutions

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