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Completed

NCT Number: NCT00609375

Efficacy of Cefepime Continuous Infusion Versus an Intermittent Dosing Regimen

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.

Completed

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital San Juan de Dios, Rionegro, Antioquia, Colombia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: maxipime

Primary outcomes

  1. To evaluate global mortality rate

    Time frame: 28 days

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Javeriana University

Other

Collaborators

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

Registry information

Official study title

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

Acronym: CEFPK/PD

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Feb 7, 2008
Registry last updated
Feb 7, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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