Efficacy of Cefepime Continuous Infusion Versus an Intermittent Dosing Regimen

Study Overview
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Brief Summary
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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.

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

Conditions
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Sepsis, Bacteremia

Intervention / Treatment
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* Drug: cefepime
* Drug: cefepime


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: I<br>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<br>* 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.<br>* Other names: maxipime;|
| Active Comparator: II<br>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<br>* 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<br>* Other names: Maxipime;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate global mortality rate |  | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sepsis, Bacteremia, Intravenous infusions, cefepime