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

Javeriana University

Status and phase: Completed; Phase 4

Conditions: Bacteremia; Sepsis

Treatments: Drug: cefepime

Study type: Interventional

Funder types: Other

Identifiers

NCT00609375

Universidad Javeriana

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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30 participants in 2 patient groups

I

Experimental group

Description:

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.

Treatment:

Drug: cefepime

Drug: cefepime

II

Active Comparator group

Description:

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

Treatment:

Drug: cefepime

Drug: cefepime