Efficacy of Cefepime Continuous Infusion Versus an Intermittent Dosing Regimen

Condition(s) targeted: Sepsis; Bacteremia

Intervention: cefepime (Drug); cefepime (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Javeriana University

Official(s) and/or principal investigator(s):
carlos A Alvarez, MD, Principal Investigator, Affiliation: Pontificia Universidad Javeriana
Alvaro Ruiz, MD; MSc, Study Chair, Affiliation: Pontificia Universidad Javeriana
Fabian GIL, Msc, Study Chair, Affiliation: Pontificia Universidad Javeriana

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.

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

Study design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study

Primary outcome: To evaluate global mortality rate

Secondary outcome:

to evaluate clinical and/or microbiologic relapses

To evaluate clinical and bacteriological response

to evaluate clinical and bacteriological response

to evaluate clinical and bacteriological response

Minimum age: 18 Years. Maximum age: 90 Years. Gender(s): Both.

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

Hospital San Juan de Dios, Rionegro, Antioquia, Colombia

Hospital Universitario san Ignacio, Bogota, DC 6, Colombia

Hospital Santa Clara, Bogota, DC 6, Colombia

Clinica Palermo, Bogota, DC 6, Colombia

Fundacion San Carlos, Bogota, DC 6, Colombia

Hospital Simon Bolivar, Bogota, DC 6, Colombia

Hospital San Jorge, Pareira, Risaralda, Colombia

Starting date: September 2006
Ending date: December 2007
Last updated: February 6, 2008