Clinical trial NCT00609375: Efficacy of Cefepime Continuous Infusion Versus an Intermittent Dosing Regimen
Official title: Efficacy of Cefepime Continuous Infusion Versus an Intermittent Dosing Regimen in Adult Critically Ill Patients With Gram Negative Bacilli Bacteremia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Sepsis
Bacteremia
Keywords: Sepsis
Bacteremia
Intravenous infusions
cefepime
Lead sponsor: Javeriana University
Sponsor class: OTHER
Collaborators: name: Asociacion Colombiana de Infectologia, ACIN. Infectious Diseases Society of Colombia
name: Hospital Simon Bolivar, Bogota
name: Clinica Palermo, Bogota
name: Hospital Santa Clara, Bogota
name: Fundación San Carlos, Bogota
name: Hospital san Juan de Dios, Antioquia
name: Hospital san Jorge, Pereira
First posted: 2008-02-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: To evaluate global mortality rate
timeFrame: 28 days
Secondary outcomes:
measure: to evaluate clinical and/or microbiologic relapses
timeFrame: 28 days
measure: To evaluate clinical and bacteriological response
timeFrame: 3 days
measure: to evaluate clinical and bacteriological response
timeFrame: 7 days
measure: to evaluate clinical and bacteriological response
timeFrame: 14 days
Other outcomes:
Locations:
city: Rionegro
country: Colombia
facility: Hospital San Juan de Dios
state: Antioquia
city: Bogota
country: Colombia
facility: Clinica Palermo
state: DC
city: Bogota
country: Colombia
facility: Fundacion San Carlos
state: DC
city: Bogota
country: Colombia
facility: Hospital Santa Clara
state: DC
city: Bogota
country: Colombia
facility: Hospital Simon Bolivar
state: DC
city: Bogota
country: Colombia
facility: Hospital Universitario san Ignacio
state: DC
city: Pareira
country: Colombia
facility: Hospital San Jorge
state: Risaralda
Study officials:
affiliation: Pontificia Universidad Javeriana
name: carlos A Alvarez, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Pontificia Universidad Javeriana
name: Alvaro Ruiz, MD; MSc
role: STUDY_CHAIR
affiliation: Pontificia Universidad Javeriana
name: Fabian GIL, Msc
role: STUDY_CHAIR
References: