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

Primary Purpose

Sepsis, Bacteremia

Status

Completed

Phase

Phase 4

Locations

Colombia

Study Type

Interventional

Intervention

cefepime

About this trial

This is an interventional treatment trial for Sepsis focused on measuring Sepsis, Bacteremia, Intravenous infusions, cefepime

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Hospital San Juan de Dios
Clinica Palermo
Fundacion San Carlos
Hospital Santa Clara
Hospital Simon Bolivar
Hospital Universitario san Ignacio
Hospital San Jorge

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

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.

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

Outcomes

Primary Outcome Measures

To evaluate global mortality rate

Secondary Outcome Measures

to evaluate clinical and/or microbiologic relapses

To evaluate clinical and bacteriological response

to evaluate clinical and bacteriological response

Full Information

NCT ID

NCT00609375

First Posted

January 24, 2008

Last Updated

February 6, 2008

Sponsor

Javeriana University

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT00609375

Brief Title

Efficacy of Cefepime Continuous Infusion Versus an Intermittent Dosing Regimen

Acronym

CEFPK/PD

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2008

Overall Recruitment Status

Completed

Study Start Date

September 2006 (undefined)

Primary Completion Date

December 2007 (Actual)

Study Completion Date

December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Javeriana University

Collaborators

4. Oversight

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sepsis, Bacteremia

Keywords

Sepsis, Bacteremia, Intravenous infusions, cefepime

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Arm Title

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

cefepime

Other Intervention Name(s)

maxipime

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

cefepime

Other Intervention Name(s)

Maxipime

Intervention Description

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

Primary Outcome Measure Information:

Title

To evaluate global mortality rate

Time Frame

28 days

Secondary Outcome Measure Information:

Title

to evaluate clinical and/or microbiologic relapses

Time Frame

28 days

Title

To evaluate clinical and bacteriological response

Time Frame

3 days

Title

to evaluate clinical and bacteriological response

Time Frame

7 days

Title

to evaluate clinical and bacteriological response

Time Frame

14 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

carlos A Alvarez, MD

Organizational Affiliation

Pontificia Universidad Javeriana

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Alvaro Ruiz, MD; MSc

Organizational Affiliation

Pontificia Universidad Javeriana

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Fabian GIL, Msc

Organizational Affiliation

Pontificia Universidad Javeriana

Official's Role

Study Chair

Facility Information:

Facility Name

Hospital San Juan de Dios

City

Rionegro

State/Province

Antioquia

Country

Colombia

Facility Name

Clinica Palermo

City

Bogota

State/Province

ZIP/Postal Code

Country

Colombia

Facility Name

Fundacion San Carlos

City

Bogota

State/Province

ZIP/Postal Code

Country

Colombia

Facility Name

Hospital Santa Clara

City

Bogota

State/Province

ZIP/Postal Code

Country

Colombia

Facility Name

Hospital Simon Bolivar

City

Bogota

State/Province

ZIP/Postal Code

Country

Colombia

Facility Name

Hospital Universitario san Ignacio

City

Bogota

State/Province

ZIP/Postal Code

Country

Colombia

Facility Name

Hospital San Jorge

City

Pareira

State/Province

Risaralda

Country

Colombia

12. IPD Sharing Statement

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Efficacy of Cefepime Continuous Infusion Versus an Intermittent Dosing Regimen

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