Procalcitonin Protocol to Shorten the Antibiotic Therapy in Febrile Neutropenia

This study has been completed.
Sponsor:
Information provided by:
Federal University of Minas Gerais
ClinicalTrials.gov Identifier:
NCT00928291
First received: June 23, 2009
Last updated: June 22, 2011
Last verified: December 2009
  Purpose

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 university hospital, causing no harm.


Condition Intervention
Febrile Neutropenia
Other: procalcitonin
Drug: antibiotic therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Use of a Procalcitonin (PCT)-Guided Protocol to Shorten the Duration of Antibiotic Therapy in Febrile Neutropenic Patients. An Interventional Study.

Resource links provided by NLM:


Further study details as provided by Federal University of Minas Gerais:

Primary Outcome Measures:
  • Antibiotic exposure, measured by: - incidence density of ''antibiotic exposure days'' - incidence rate ratio (IRR) of antibiotic exposure [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Number of days alive without antibiotics [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Duration of antibiotic therapy for the first episode of fever [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Length of hospital stay [ Time Frame: 6 m ] [ Designated as safety issue: No ]
  • All cause and infection-related 28-day mortality [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • All cause 90-day mortality [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • Clinical cure rate [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • Nosocomial superinfection (diagnosed more than 48 hours after discontinuation of the antibiotic(s) given to the first episode of infection) [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • Infection relapse (diagnosed less than 48 h after antibiotic discontinuation) [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: January 2010
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1 - PCT group
interventions on antibiotic therapy will be based on circulating PCT levels
Other: procalcitonin
plasma PCT measurement
Drug: antibiotic therapy
antibiotic therapy use
Active Comparator: Group 2 - Control group
antibiotic therapy will be guided by appropriate guidelines, and will be left at the discretion of caregivers.
Other: procalcitonin
plasma PCT measurement
Drug: antibiotic therapy
antibiotic therapy use

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age > 18 years
  • febrile neutropenia
  • to be under antibiotic therapy
  • signed informed consent

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00928291

Locations
Brazil
Hospital das Clínicas da Universidade Federal de Minas Gerais
Belo Horizonte, Minas Gerais, Brazil, 30130100
Sponsors and Collaborators
Federal University of Minas Gerais
Investigators
Study Chair: Vandack Nobre, PhD Medicine Faculty of Federal University of Minas Gerais
Study Chair: Stella SS Lima, MD Medicine Faculty of Federal University of Minas Gerais
Study Chair: Henrique NS Bittencourt, PhD Medicine Faculty of Federal University of Minas Gerais
Principal Investigator: José C Serufo, PhD Medicine Faculty of Federal University of Minas Gerais
  More Information

No publications provided

Responsible Party: Vandack Nobre, Associate Professor, PhD
ClinicalTrials.gov Identifier: NCT00928291     History of Changes
Other Study ID Numbers: PCT febrile neutropenia
Study First Received: June 23, 2009
Last Updated: June 22, 2011
Health Authority: Brazil: Ethics Committee

Keywords provided by Federal University of Minas Gerais:
procalcitonin
neutropenia
febrile neutropenia
antibiotic therapy
neutropenic patients

Additional relevant MeSH terms:
Fever
Neutropenia
Febrile Neutropenia
Body Temperature Changes
Signs and Symptoms
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents

ClinicalTrials.gov processed this record on August 28, 2014