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

• ClinicalTrials.gov Identifier: NCT00609375
• Recruitment Status: Completed
• First Posted: February 7, 2008
• Last Update Posted: February 7, 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
• Information provided by: Javeriana University

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	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• 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: September 2006
• Actual Primary Completion Date: December 2007
• Actual Study Completion Date: December 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 Name: 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 Name: Maxipime

Outcome Measures

Primary Outcome Measures :

1. To evaluate global mortality rate [ Time Frame: 28 days ]

Secondary Outcome Measures :

1. to evaluate clinical and/or microbiologic relapses [ Time Frame: 28 days ]
2. To evaluate clinical and bacteriological response [ Time Frame: 3 days ]
3. to evaluate clinical and bacteriological response [ Time Frame: 7 days ]
4. to evaluate clinical and bacteriological response [ Time Frame: 14 days ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 90 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Colombia

Hospital San Juan de Dios

Rionegro, Antioquia, Colombia

Clinica Palermo

Bogota, DC, Colombia, 6

Fundacion San Carlos

Bogota, DC, Colombia, 6

Hospital Santa Clara

Bogota, DC, Colombia, 6

Hospital Simon Bolivar

Bogota, DC, Colombia, 6

Hospital Universitario san Ignacio

Bogota, DC, Colombia, 6

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

Investigators

• 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

More Information

• Responsible Party: Carlos Arturo Alvarez, Medicine School, Pontificia Universidad javeriana
• ClinicalTrials.gov Identifier: NCT00609375
• Other Study ID Numbers: Universidad Javeriana
• First Posted: February 7, 2008
• Last Update Posted: February 7, 2008
• Last Verified: January 2008

Keywords provided by Javeriana University:

Sepsis; Bacteremia; Intravenous infusions; cefepime

Additional relevant MeSH terms:

Bacteremia; Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Bacterial Infections; Bacterial Infections and Mycoses; Cefepime; Anti-Bacterial Agents; Anti-Infective Agents