Efficacy of Cefepime Continuous Infusion Versus an Intermittent Dosing Regimen

NCT00609375 | Completed Phase 4 DMC

• 1 other identifier: Universidad Javeriana
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 7

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.

Conditions

Sepsis; Bacteremia

Keywords

Sepsis; Bacteremia; Intravenous infusions; cefepime

Outcome Measures

Primary Outcomes (1)

• To evaluate global mortality rate

  28 days

Secondary Outcomes (4)

• 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

Study Arms (2)

I

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.

Drug: cefepime

II

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

Drug: cefepime

Interventions

cefepime DRUG

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.

Also known as: maxipime

I

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Javeriana University: lead
• Asociacion Colombiana de Infectologia, ACIN. Infectious Diseases Society of Colombia: collaborator
• Hospital Simon Bolivar, Bogota: collaborator
• Clinica Palermo, Bogota: collaborator
• Hospital Santa Clara, Bogota: collaborator
• Fundación San Carlos, Bogota: collaborator
• Hospital san Juan de Dios, Antioquia: collaborator
• Hospital san Jorge, Pereira: collaborator

Study Sites (7)

Hospital San Juan de Dios

Rionegro, Antioquia, Colombia

Location

Clinica Palermo

Bogotá, DC, 6, Colombia

Location

Fundacion San Carlos

Bogotá, DC, 6, Colombia

Location

Hospital Santa Clara

Bogotá, DC, 6, Colombia

Location

Hospital Simon Bolivar

Bogotá, DC, 6, Colombia

Location

Hospital Universitario san Ignacio

Bogotá, DC, 6, Colombia

Location

Hospital San Jorge

Pareira, Risaralda Department, Colombia

Location

MeSH Terms

Conditions

Sepsis; Bacteremia

Interventions

Cefepime

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bacterial Infections; Bacterial Infections and Mycoses

Intervention Hierarchy (Ancestors)

Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• carlos A Alvarez, MD

  Pontificia Universidad Javeriana

  PRINCIPAL INVESTIGATOR

• Alvaro Ruiz, MD; MSc

  Pontificia Universidad Javeriana

  STUDY CHAIR

• Fabian GIL, Msc

  Pontificia Universidad Javeriana

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 24, 2008
• First Posted: February 7, 2008
• Study Start: September 1, 2006
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: February 7, 2008

Record last verified: 2008-01

Locations

CO (7)