Bacteremia, Sepsis
Conditions
Keywords
Sepsis, Bacteremia, Intravenous infusions, cefepime
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.
Interventions
DRUGcefepime
Administration of cefepime in continuous infusion (3 Gr over 24 hours) for 7-14 days at the discretion of the investigator. Administration of saline solution 0.9%, 50-100 mL over 30 minutes every 8 hours.
Sponsors
Asociacion Colombiana de Infectologia, ACIN. Infectious Diseases Society of Colombia
Hospital Simon Bolivar, Bogota
Clinica Palermo, Bogota
Hospital Santa Clara, Bogota
Fundación San Carlos, Bogota
Hospital san Juan de Dios, Antioquia
Hospital san Jorge, Pereira
Javeriana University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate global mortality rate | 28 days |
Secondary
| Measure | Time frame |
|---|---|
| to evaluate clinical and/or microbiologic relapses | 28 days |
| To evaluate clinical and bacteriological response | 3 days |
| to evaluate clinical and bacteriological response | 7 days |
Countries
Colombia
Outcome results
None listed