| January 24, 2008 |
| February 6, 2008 |
| September 2006 |
| December 2007 (final data collection date for primary outcome measure) |
| To evaluate global mortality rate [ Time Frame: 28 days ] [ Designated as safety issue: No ] |
| Same as current |
| Complete list of historical versions of study NCT00609375 on ClinicalTrials.gov Archive Site |
- to evaluate clinical and/or microbiologic relapses [ Time Frame: 28 days ] [ Designated as safety issue: No ]
- To evaluate clinical and bacteriological response [ Time Frame: 3 days ] [ Designated as safety issue: No ]
- to evaluate clinical and bacteriological response [ Time Frame: 7 days ] [ Designated as safety issue: No ]
- to evaluate clinical and bacteriological response [ Time Frame: 14 days ] [ Designated as safety issue: No ]
|
| Same as current |
| |
| Efficacy of Cefepime Continuous Infusion Versus an Intermittent Dosing Regimen |
| Efficacy of Cefepime Continuous Infusion Versus an Intermittent Dosing Regimen in Adult Critically Ill Patients With Gram Negative Bacilli Bacteremia |
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. |
| |
| Phase IV |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study |
|
|
| Drug: cefepime |
- 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.
- 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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| |
| |
| Completed |
| 30 |
| December 2007 |
| December 2007 (final data collection date for primary outcome measure) |
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:
|
| Both |
| 18 Years to 90 Years |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| Colombia |
| |
| NCT00609375 |
| Carlos Arturo Alvarez, Medicine School, Pontificia Universidad javeriana |
| Universidad Javeriana |
| 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
|
| 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 |
|
|
| Javeriana University |
| January 2008 |