Efficacy of Cefepime Continuous Infusion Versus an Intermittent Dosing Regimen
- Registration Number
- NCT00609375
- Lead Sponsor
- Javeriana University
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- 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
-
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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description I cefepime 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. II cefepime 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
- Primary Outcome Measures
Name Time Method To evaluate global mortality rate 28 days
- Secondary Outcome Measures
Name Time Method to evaluate clinical and/or microbiologic relapses 28 days To evaluate clinical and bacteriological response 3 days to evaluate clinical and bacteriological response 14 days
Trial Locations
- Locations (7)
Fundacion San Carlos
🇨🇴Bogota, DC, Colombia
Hospital Santa Clara
🇨🇴Bogota, DC, Colombia
Hospital Universitario san Ignacio
🇨🇴Bogota, DC, Colombia
Hospital San Jorge
🇨🇴Pareira, Risaralda, Colombia
Clinica Palermo
🇨🇴Bogota, DC, Colombia
Hospital San Juan de Dios
🇨🇴Rionegro, Antioquia, Colombia
Hospital Simon Bolivar
🇨🇴Bogota, DC, Colombia