Prolonged Infusion Cefepime and Nosocomial Infections

Urinary Tract Infection Clinical Trial

— PICNIC  

Official title:

Prolonged Infusion Cefepime and Nosocomial Infections

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02568800
• Other study ID #: 15-0392
• Status: Recruiting
• Phase: Phase 3
• First received: October 2, 2015
• Last updated: October 15, 2015
• Start date: October 2015
• Est. completion date: September 2016

Study information

• Verified date: October 2015
• Source: Hospital de Clinicas de Porto Alegre
• Contact: André Dias Américo
• Phone: +555193112207
• Email: adamerico[@]hcpa.edu.br
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 134
• Est. completion date: September 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Communicable Diseases
• Cross Infection
• Infection
• Respiratory Tract Infection
• Respiratory Tract Infections
• Urinary Tract Infection
• Urinary Tract Infections

Intervention

Drug:
• Prolonged Cefepime Infusion
Cefepime infusion should last at least 4 hours with the aide of an infusion bomb
• Usual Cefepime Infusion
Cefepime infusion occurs directly without the aide of an infusion bomb, lasting roughly thirty minutes

Locations

Country	Name	City	State
Brazil	Hospital de Clínicas de Porto Alegre	Porto Alegre	Rio Grande do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Death	Death in 30 days since randomization	30 days	No
Secondary	Death	Death in 14 days since randomization	14 days	No
Secondary	Duration of hospital stay	Duration of hospital stay	30 days since randomization	No
Secondary	Intensive care unit (ICU) admission	Intensive care necessity for any reason	30 days since randomization	No
Secondary	Duration of intensive care unit (ICU) stay	Number of days when intensive care was considered necessary	30 days since randomization	No
Secondary	Treatment change	Treatment change required based com clinical or microbiological data	3 days after randomization	No
Secondary	Treatment success	Patient reaching the completion until it end with infection resolution	30 days since randomization	No
Secondary	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)	3 days	No