Working… Menu

Procalcitonin Protocol to Shorten the Antibiotic Therapy in Febrile Neutropenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00928291
Recruitment Status : Completed
First Posted : June 25, 2009
Last Update Posted : June 23, 2011
Information provided by:
Federal University of Minas Gerais

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 university hospital, causing no harm.

Condition or disease Intervention/treatment Phase
Febrile Neutropenia Other: procalcitonin Drug: antibiotic therapy Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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.
Study Start Date : January 2010
Actual Primary Completion Date : April 2011
Actual Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics Fever

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Antibiotic exposure, measured by: - incidence density of ''antibiotic exposure days'' - incidence rate ratio (IRR) of antibiotic exposure [ Time Frame: 28 days ]
  2. Number of days alive without antibiotics [ Time Frame: 28 days ]
  3. Duration of antibiotic therapy for the first episode of fever [ Time Frame: 28 days ]

Secondary Outcome Measures :
  1. Length of hospital stay [ Time Frame: 6 m ]
  2. All cause and infection-related 28-day mortality [ Time Frame: 28 days ]
  3. All cause 90-day mortality [ Time Frame: 90 days ]
  4. Clinical cure rate [ Time Frame: 28 days ]
  5. Nosocomial superinfection (diagnosed more than 48 hours after discontinuation of the antibiotic(s) given to the first episode of infection) [ Time Frame: 28 days ]
  6. Infection relapse (diagnosed less than 48 h after antibiotic discontinuation) [ Time Frame: 48 hours ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00928291

Layout table for location information
Hospital das Clínicas da Universidade Federal de Minas Gerais
Belo Horizonte, Minas Gerais, Brazil, 30130100
Sponsors and Collaborators
Federal University of Minas Gerais
Layout table for investigator information
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

Layout table for additonal information
Responsible Party: Vandack Nobre, Associate Professor, PhD Identifier: NCT00928291     History of Changes
Other Study ID Numbers: PCT febrile neutropenia
First Posted: June 25, 2009    Key Record Dates
Last Update Posted: June 23, 2011
Last Verified: December 2009
Keywords provided by Federal University of Minas Gerais:
febrile neutropenia
antibiotic therapy
neutropenic patients
Additional relevant MeSH terms:
Layout table for MeSH terms
Febrile Neutropenia
Leukocyte Disorders
Hematologic Diseases
Body Temperature Changes
Signs and Symptoms
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents