Prolonged Infusion Cefepime and Nosocomial Infections
PICNIC
1 other identifier
interventional
134
1 country
1
Brief Summary
It is advocated that prolonged infusion of beta-lactamic antibiotics provides better bactericidal effect. The aim of the present study is to randomize patients a to extended cefepime infusion regimen (lasting four hours) or to a usual infusion regimen (not lasting more than thirty minutes) and evaluate the clinical efficacy of this theoretical pharmacokinetic advantage.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Oct 2015
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
October 2, 2015
CompletedFirst Posted
Study publicly available on registry
October 6, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2016
CompletedOctober 16, 2015
October 1, 2015
5 months
October 2, 2015
October 15, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Death
Death in 30 days since randomization
30 days
Secondary Outcomes (7)
Death
14 days
Duration of hospital stay
30 days since randomization
Intensive care unit (ICU) admission
30 days since randomization
Duration of intensive care unit (ICU) stay
30 days since randomization
Treatment change
3 days after randomization
- +2 more secondary outcomes
Study Arms (2)
Prolonged Cefepime Infusion
EXPERIMENTALCefepime infusions should last 4 hours at least
Usual Cefepime Infusion
ACTIVE COMPARATORCefepime infusion should last no more than 30 minutes
Interventions
Cefepime infusion should last at least 4 hours with the aide of an infusion bomb
Cefepime infusion occurs directly without the aide of an infusion bomb, lasting roughly thirty minutes
Eligibility Criteria
You may qualify if:
- Urinary tract infection after 48-72 hours of hospital stay
- Respiratory tract infection after 48-72 hours of hospital stay
- Catheter related urinary tract infection after 48-72 hours of hospital stay
- Urinary or respiratory infections not responding to a narrower spectrum antibiotic
- Isolation of bacteria sensible to cefepime in blood, urine or sputum in a clinical context of infection
You may not qualify if:
- Glomerular filtration rate lower than 30 ml.min/1,73m²
- ICU admission for at least 72 hours before randomization
- Neutrophil count lower than 1000 cels per mm³
- Hematologic malignancy, bronchiectasis and cystic fibrosis
- Patients allergic to cefepime
- Concomitant treatment to another infectious disease
- Central nervous system, cutaneous or intrabdominal infections
- Solid organ transplantation
- HIV with a cluster differentiation 4 (CD4) lower than 100 cels per mm³
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eduardo Sprinz
Hospita de Clínicas de Porto Alegre
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 2, 2015
First Posted
October 6, 2015
Study Start
October 1, 2015
Primary Completion
March 1, 2016
Study Completion
September 1, 2016
Last Updated
October 16, 2015
Record last verified: 2015-10