Validation of an Index of Neutropenia (D-index) in Febrile Neutropenic Cancer Patients

Validation of an Index of Neutropenia (D-index) in Febrile Neutropenic Cancer Patients (Dindexval)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by Federal University of Rio de Janeiro.   Recruitment status was  Not yet recruiting

First Received on September 22, 2009.  
No Changes Posted
Sponsor: Federal University of Rio de Janeiro
Collaborator: Federal University of São Paulo
Information provided by: Federal University of Rio de Janeiro
ClinicalTrials.gov Identifier: NCT00982540
  Purpose

The main objective of this study is to test prospectively the performance of an algorithm stratified by an index based on neutrophil counts in association with galactomannan assay and image tests to start an antifungal early therapy (empirical/preemptive) in neutropenic patients. Ths specific objectives are to determine the overall incidence of invasive fungal infections, use of antifungal agents, duration of hospitalization and mortality in this cohort, and to evaluate if this strategy is associated with a reduction in the expected use of antifungal agents if a classical empiric antifungal strategy was used, without an increase in the incidence of invasive fungal infections.

This is a prospective, non randomized, non comparative study. Patients aged ≥ 18 years are eligible if they have acute leukemia, myelodysplasia or other baseline disease submitted to chemotherapy or to allogeneic stem cell transplantation with an expected duration of neutropenia (neutrophil count <500cells/mm³) of at least 10 days. Exclusion criteria are patients with and a past history of or invasive mold infection and those who do not want to participate. The study has no comparator arm. However, the investigators intend to determine if the algorithm based on the D-index would result in a 50% reduction in the use of antifungal agents, if all patients with persistent fever and neutropenia received empiric antifungal therapy. Based on our database of ~2,000 episodes of febrile neutropenia, 36% of patients had persistent fever between days 4 and 7 of antibiotics and would receive empiric antifungal therapy. A total of 105 patients will be needed to demonstrate a 50% reduction in antifungal use if the investigators compared this cohort with a matched control historical cohort (alpha = 5%, beta = 20%).

Condition Intervention
Invasive Fungal Infections
Invasive Aspergillosis
Invasive Fusariosis
Drug: caspofungin as preemptive antifungal therapy

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Empirical Antifungal Treatment in Neutropenic Patients Stratified by Risk: Prospective Validation of an Algorithm Based on the D-index

Resource links provided by NLM:

Further study details as provided by Federal University of Rio de Janeiro:

Primary Outcome Measures:

  • Incidence of suspected and documented mold infection, use of anti mold therapy, duration of hospitalization and death rate. [ Time Frame: At the end of the episode of febrile neutropenia ] [ Designated as safety issue: No ]

Estimated Enrollment: 105
Study Start Date: February 2010
Estimated Study Completion Date: January 2011
Estimated Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)

Arms

Assigned Interventions
No Intervention: preemptive

Patients with persistent fever and neutropenia despite appropriate antibacterial therapy
Drug: caspofungin as preemptive antifungal therapy

70 mg day 1 followed by 50 mg/day IV

 
Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age 18 years or more
  • acute myeloid leukemia or myelosysplasia undergoing induction remission or consolidation therapy
  • allogeneic stem cell transplant recipients

Exclusion Criteria:

  • prior invasive mould infection
  Contacts and Locations

No Contacts or Locations Provided

  More Information

No publications provided

Responsible Party: Marcio Nucci, Universidade Federal do Rio de Janeiro
ClinicalTrials.gov Identifier: NCT00982540    
History of Changes
Other Study ID Numbers: MSD – IISP 36773
Study First Received: September 22, 2009
Last Updated: September 22, 2009
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Federal University of Rio de Janeiro:

empiric antifungal therapy
preemptive antifungal therapy
febrile neutropenia
risk stratification
invasive fungal infection

Additional relevant MeSH terms:

Aspergillosis
Mycoses
Neutropenia
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases
Antifungal Agents
Clotrimazole
Miconazole
Caspofungin
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Infective Agents, Local
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 21, 2012

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