Sepsis Clinical Trial
— CEFPK/PDOfficial title:
Efficacy of Cefepime Continuous Infusion Versus an Intermittent Dosing Regimen in Adult Critically Ill Patients With Gram Negative Bacilli Bacteremia
Verified date | January 2008 |
Source | Javeriana University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Colombia: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | December 2007 |
Est. primary completion date | December 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 90 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Colombia | Clinica Palermo | Bogota | DC |
Colombia | Fundacion San Carlos | Bogota | DC |
Colombia | Hospital Santa Clara | Bogota | DC |
Colombia | Hospital Simon Bolivar | Bogota | DC |
Colombia | Hospital Universitario san Ignacio | Bogota | DC |
Colombia | Hospital San Jorge | Pareira | Risaralda |
Colombia | Hospital San Juan de Dios | Rionegro | Antioquia |
Lead Sponsor | Collaborator |
---|---|
Javeriana University | Asociacion Colombiana de Infectologia, ACIN. Infectious Diseases Society of Colombia, Clinica Palermo, Bogota, Fundación San Carlos, Bogota, Hospital san Jorge, Pereira, Hospital san Juan de Dios, Antioquia, Hospital Santa Clara, Bogota, Hospital Simon Bolivar, Bogota |
Colombia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To evaluate global mortality rate | 28 days | No | |
Secondary | to evaluate clinical and/or microbiologic relapses | 28 days | No | |
Secondary | To evaluate clinical and bacteriological response | 3 days | No | |
Secondary | to evaluate clinical and bacteriological response | 7 days | No | |
Secondary | to evaluate clinical and bacteriological response | 14 days | No |
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