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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
History of Changes
  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:

MedlinePlus related topics: Antibiotics Fever
U.S. FDA Resources

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
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
Body Temperature Changes
Signs and Symptoms
Agranulocytosis
Leukopenia
 Leukocyte Disorders
Hematologic Diseases
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013