NCT00928291

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 23, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 25, 2009

Completed
6 months until next milestone

Study Start

First participant enrolled

January 1, 2010

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

June 23, 2011

Status Verified

December 1, 2009

Enrollment Period

1.2 years

First QC Date

June 23, 2009

Last Update Submit

June 22, 2011

Conditions

Febrile Neutropenia

Keywords

procalcitoninneutropeniafebrile neutropeniaantibiotic therapyneutropenic patients

Outcome Measures

Primary Outcomes (3)

  • Antibiotic exposure, measured by: - incidence density of ''antibiotic exposure days'' - incidence rate ratio (IRR) of antibiotic exposure

    28 days

  • Number of days alive without antibiotics

    28 days

  • Duration of antibiotic therapy for the first episode of fever

    28 days

Secondary Outcomes (6)

  • Length of hospital stay

    6 m

  • All cause and infection-related 28-day mortality

    28 days

  • All cause 90-day mortality

    90 days

  • Clinical cure rate

    28 days

  • Nosocomial superinfection (diagnosed more than 48 hours after discontinuation of the antibiotic(s) given to the first episode of infection)

    28 days

  • +1 more secondary outcomes

Study Arms (2)

Group 1 - PCT group

EXPERIMENTAL

interventions on antibiotic therapy will be based on circulating PCT levels

Other: procalcitoninDrug: antibiotic therapy

Group 2 - Control group

ACTIVE COMPARATOR

antibiotic therapy will be guided by appropriate guidelines, and will be left at the discretion of caregivers.

Other: procalcitoninDrug: antibiotic therapy

Interventions

procalcitoninOTHER

plasma PCT measurement

Group 1 - PCT groupGroup 2 - Control group
antibiotic therapyDRUG

antibiotic therapy use

Group 1 - PCT groupGroup 2 - Control group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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
  • infections requiring prolonged therapies, such as endocarditis and cerebral abscess
  • clearly focal bacterial infections

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital das Clínicas da Universidade Federal de Minas Gerais

Belo Horizonte, Minas Gerais, 30130100, Brazil

Location

MeSH Terms

Conditions

Febrile NeutropeniaNeutropenia

Interventions

ProcalcitoninAnti-Infective Agents

Condition Hierarchy (Ancestors)

AgranulocytosisLeukopeniaCytopeniaHematologic DiseasesHemic and Lymphatic DiseasesLeukocyte Disorders

Intervention Hierarchy (Ancestors)

CalcitoninPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsProtein PrecursorsProteinsTherapeutic UsesPharmacologic ActionsChemical Actions and Uses

Study Officials

  • 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

    STUDY CHAIR

  • José C Serufo, PhD

    Medicine Faculty of Federal University of Minas Gerais

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 23, 2009

First Posted

June 25, 2009

Study Start

January 1, 2010

Primary Completion

April 1, 2011

Study Completion

April 1, 2011

Last Updated

June 23, 2011

Record last verified: 2009-12

Locations

BR(1)