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Sponsors and Collaborators: |
Javeriana University 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 |
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Information provided by: | Javeriana University |
ClinicalTrials.gov Identifier: | NCT00609375 |
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.
Condition | Intervention | Phase |
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Sepsis Bacteremia |
Drug: cefepime |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study |
Official Title: | Efficacy of Cefepime Continuous Infusion Versus an Intermittent Dosing Regimen in Adult Critically Ill Patients With Gram Negative Bacilli Bacteremia |
Enrollment: | 30 |
Study Start Date: | September 2006 |
Study Completion Date: | December 2007 |
Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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I: Experimental
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.
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Drug: cefepime
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.
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II: Active Comparator
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
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Drug: cefepime
Administration of cefepime in intermittent infusion (1 Gr over 30 minutes every 8 hours) for 7-14 days at the discretion of the investigator.Administration of saline solution 0.9%, 50-250 mL over 24 hours
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Ages Eligible for Study: | 18 Years to 90 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Patients with a high degree of immunosuppression defined by:
Colombia, Antioquia | |
Hospital San Juan de Dios | |
Rionegro, Antioquia, Colombia | |
Colombia, DC | |
Hospital Universitario san Ignacio | |
Bogota, DC, Colombia, 6 | |
Hospital Santa Clara | |
Bogota, DC, Colombia, 6 | |
Clinica Palermo | |
Bogota, DC, Colombia, 6 | |
Fundacion San Carlos | |
Bogota, DC, Colombia, 6 | |
Hospital Simon Bolivar | |
Bogota, DC, Colombia, 6 | |
Colombia, Risaralda | |
Hospital San Jorge | |
Pareira, Risaralda, Colombia |
Principal Investigator: | carlos A Alvarez, MD | Pontificia Universidad Javeriana |
Study Chair: | Alvaro Ruiz, MD; MSc | Pontificia Universidad Javeriana |
Study Chair: | Fabian GIL, Msc | Pontificia Universidad Javeriana |
Responsible Party: | Medicine School, Pontificia Universidad javeriana ( Carlos Arturo Alvarez ) |
Study ID Numbers: | Universidad Javeriana |
Study First Received: | January 24, 2008 |
Last Updated: | February 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00609375 History of Changes |
Health Authority: | Colombia: Institutional Review Board |
Sepsis Bacteremia Intravenous infusions cefepime |
Systemic Inflammatory Response Syndrome Bacterial Infections Anti-Bacterial Agents Sepsis |
Cefepime Critical Illness Bacteremia Inflammation |
Systemic Inflammatory Response Syndrome Bacterial Infections Anti-Infective Agents Anti-Bacterial Agents Sepsis Pathologic Processes |
Cefepime Therapeutic Uses Bacteremia Infection Pharmacologic Actions Inflammation |