Status:
COMPLETED
Procalcitonin Protocol to Shorten the Antibiotic Therapy in Febrile Neutropenia
Lead Sponsor:
Federal University of Minas Gerais
Conditions:
Febrile Neutropenia
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
In this study the investigators aim to test if a procalcitonin (PCT) - guided strategy allows to reduce the antibiotic use in patients with febrile neutropenia hospitalized in a Brazilian tertiary uni...
Detailed Description
Methods * Patients and setting: Prospective controlled randomized interventional study of antibiotic therapy in adult with febrile neutropenia. The study will be conducted in the University Hospital...
Eligibility Criteria
Inclusion
- age \> 18 years
- febrile neutropenia
- to be under antibiotic therapy
- signed informed consent
Exclusion
- patients under antibiotic therapy for more than 72 hours before inclusion
- patients post allogenic bone-marrow transplant (BMT)
- patients presenting one or more of the following conditions at the time of randomization:
- severe mucositis
- all-trans retinoic acid (ATRA) syndrome
- disseminated intravascular coagulation
- hypotension (systolic blood pressure \< 90 mmHg or need for vasopressor to maintain blood pressure)
- respiratory failure (arterial oxygen pressure \< 60 mmHg while breathing room air) or need for mechanical ventilation
- severe renal failure requiring hemodialysis
- patients with suspected (positive galactomannan assay in peripheral blood, nodular lesions with halo in the chest CT) or microbiologically confirmed fungal infection
- bacteremia due to S. aureus
- microbiologically confirmed carbapenem resistant P. aeruginosa or A. baumanii infection
- microbiologically confirmed pneumonia due to P. aeruginosa, A. baumanii or Stenotrophomonas maltophilla
- suspected or confirmed infection caused by atypical microorganisms (virus, parasites, P. jiroveci). Patients with localized HSV infection (e.g., labial) will be accepted for inclusion
- infections requiring prolonged therapies, such as endocarditis and cerebral abscess
- clearly focal bacterial infections
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2011
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00928291
Start Date
January 1 2010
End Date
April 1 2011
Last Update
June 23 2011
Active Locations (1)
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1
Hospital das Clínicas da Universidade Federal de Minas Gerais
Belo Horizonte, Minas Gerais, Brazil, 30130100