Overview

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