Status:
COMPLETED
Efficacy of Cefepime Continuous Infusion Versus an Intermittent Dosing Regimen
Lead Sponsor:
Javeriana University
Collaborating Sponsors:
Asociacion Colombiana de Infectologia, ACIN. Infectious Diseases Society of Colombia
Hospital Simon Bolivar, Bogota
Conditions:
Sepsis
Bacteremia
Eligibility:
All Genders
18-90 years
Phase:
PHASE4
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 se...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00609375
Start Date
September 1 2006
End Date
December 1 2007
Last Update
February 7 2008
Active Locations (7)
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1
Hospital San Juan de Dios
Rionegro, Antioquia, Colombia
2
Clinica Palermo
Bogotá, DC, Colombia, 6
3
Fundacion San Carlos
Bogotá, DC, Colombia, 6
4
Hospital Santa Clara
Bogotá, DC, Colombia, 6