CEFPK/PD: Efficacy of Cefepime Continuous Infusion Versus an Intermittent Dosing Regimen

Sponsor

Javeriana University (Other)

Overall Status

Completed

CT.gov ID

NCT00609375

Collaborator

Asociacion Colombiana de Infectologia, ACIN. Infectious Diseases Society of Colombia (Other), Hospital Simon Bolivar, Bogota (Other), Clinica Palermo, Bogota (Other), Hospital Santa Clara, Bogota (Other), Fundación San Carlos, Bogota (Other), Hospital san Juan de Dios, Antioquia (Other), Hospital san Jorge, Pereira (Other)

Enrollment

Locations

Arms

Duration (Months)

4.3

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sepsis Bacteremia	Drug: cefepime Drug: cefepime	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Efficacy of Cefepime Continuous Infusion Versus an Intermittent Dosing Regimen in Adult Critically Ill Patients With Gram Negative Bacilli Bacteremia

Study Start Date :

Sep 1, 2006

Actual Primary Completion Date :

Dec 1, 2007

Actual Study Completion Date :

Dec 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: I 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.	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. Other Names: maxipime
Active Comparator: II 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	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 Other Names: Maxipime

Arm

Intervention/Treatment

Experimental: I

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.

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.

Other Names:

maxipime

Active Comparator: II

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

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

Other Names:

Maxipime

Outcome Measures

Primary Outcome Measures

To evaluate global mortality rate [28 days]

Secondary Outcome Measures

to evaluate clinical and/or microbiologic relapses [28 days]
To evaluate clinical and bacteriological response [3 days]
to evaluate clinical and bacteriological response [7 days]
to evaluate clinical and bacteriological response [14 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital San Juan de Dios	Rionegro	Antioquia	Colombia
2	Clinica Palermo	Bogota	DC	Colombia	6
3	Fundacion San Carlos	Bogota	DC	Colombia	6
4	Hospital Santa Clara	Bogota	DC	Colombia	6
5	Hospital Simon Bolivar	Bogota	DC	Colombia	6
6	Hospital Universitario san Ignacio	Bogota	DC	Colombia	6
7	Hospital San Jorge	Pareira	Risaralda	Colombia

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