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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00609375
Other study ID # Universidad Javeriana
Secondary ID
Status Completed
Phase Phase 4
First received January 24, 2008
Last updated February 6, 2008
Start date September 2006
Est. completion date December 2007

Study information

Verified date January 2008
Source Javeriana University
Contact n/a
Is FDA regulated No
Health authority Colombia: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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.
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

Locations

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

Sponsors (8)

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

Country where clinical trial is conducted

Colombia, 

Outcome

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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