A Phase 3 interventional study of Prolonged Cefepime Infusion and Usual Cefepime Infusion in Urinary Tract Infection and Respiratory Tract Infection, sponsored by Hospital de Clinicas de Porto Alegre. Status unknown at 1 site in Brazil. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2015-10-16.
Sponsored by Hospital de Clinicas de Porto Alegre · Phase 3, Interventional, and Treatment
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.
Introduction: it has been proved that the main determinant for microbiological cure gram-negative infections treated with cefepime is the time above minimal inhibitory concentration (T>MIC). Although this particular pharmacokinetic property have never been proved in clinical trials utilizing cefepime, intervention studies with other betalactamic antibiotics, such as pipercillin-tazobactam, showed clinical benefit.
Objective: to evaluate if prolonged infusion (lasting 4 hours) with cefepime translate into better clinical outcomes.
Methods: the investigators aim to conduct an open-label, unique-centered, randomized controlled trial using cefepime in prolonged infusions in patients being treated for urinary or respiratory tract infections. Patients developing these infections after 72 hours of hospital admission, requiring the use of broader spectrum antibiotics after clinical failure or isolating gram-negative bacteria from adequate sample sensible to cefepime will be enrolled. The use of a second antibiotic such as clindamycin, vancomycin or metronidazole will be allowed.
Interventions: the investigators aim to randomize 134 patients to two different treatment arms, the intervention arm who will receive the medication in a four hour lasting infusion, and the active control arm who will receive the medication in a 30 minutes lasting infusion. The randomization will be conducted in blocks of ten patients each, and it will be balance according to the patients age (older or younger than 65 years old) and presence of SIRS criteria.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's planned enrollment of 134 is above the median of 120 across 4,201 interventional studies indexed under Infections.
Browse Infections studies →Hospital de Clinicas de Porto Alegre is the lead sponsor of 450 studies on the registry; 61 are open to participants now.
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Exclusion Criteria:
Cefepime infusions should last 4 hours at least
Drug: Prolonged Cefepime Infusion
Cefepime infusion should last no more than 30 minutes
Drug: Usual Cefepime Infusion
Cefepime infusion should last at least 4 hours with the aide of an infusion bomb
Also known as: Estended Cefepime Infusion
Cefepime infusion occurs directly without the aide of an infusion bomb, lasting roughly thirty minutes
Also known as: Regular Cefepime Infusion
Death
Death in 30 days since randomization
Time frame: 30 days
Death
Death in 14 days since randomization
Time frame: 14 days
Duration of hospital stay
Duration of hospital stay
Time frame: 30 days since randomization
Intensive care unit (ICU) admission
Intensive care necessity for any reason
Time frame: 30 days since randomization
Duration of intensive care unit (ICU) stay
Number of days when intensive care was considered necessary
Time frame: 30 days since randomization
Treatment change
Treatment change required based com clinical or microbiological data
Time frame: 3 days after randomization
Treatment success
Patient reaching the completion until it end with infection resolution
Time frame: 30 days since randomization
Time to clinical stability
Time required for patient to reach the normalization of all following vital signs: that is, body temperature lower than 37,9 degrees celsius, a cardiac rate lower than 100 beats per minute and a respiratory rate lower than 25 respiratory movements per minute and peripheral oxygen saturation higher than 91% with low oxygen requirement (that is 4 liters per minute delivered by nasal canula)
Time frame: 3 days
This study is status unknown, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.
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Hospital de Clinicas de Porto Alegre