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

This study has been terminated.
(Low accrual)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00982540
First Posted: September 23, 2009
Last Update Posted: January 29, 2014
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.
Collaborator:
Federal University of São Paulo
Information provided by (Responsible Party):
Marcio Nucci, Federal University of Rio de Janeiro
  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
Intervention Model: Single Group Assignment
Masking: None (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 Marcio Nucci, 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 ]

Enrollment: 28
Study Start Date: February 2010
Study Completion Date: December 2013
Primary Completion Date: November 2013 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): NCT00982540


Locations
Brazil
Univ. Fed. Rio de Janeiro
Rio de Janeiro, RJ, Brazil, 21941913
Sponsors and Collaborators
Universidade Federal do Rio de Janeiro
Federal University of São Paulo
  More Information

Responsible Party: Marcio Nucci, Associate Professor, Federal University of Rio de Janeiro
ClinicalTrials.gov Identifier: NCT00982540     History of Changes
Other Study ID Numbers: MSD - IISP 36773
First Submitted: September 22, 2009
First Posted: September 23, 2009
Last Update Posted: January 29, 2014
Last Verified: January 2014

Keywords provided by Marcio Nucci, Federal University of Rio de Janeiro:
empiric antifungal therapy
preemptive antifungal therapy
febrile neutropenia
risk stratification
invasive fungal infection

Additional relevant MeSH terms:
Neutropenia
Mycoses
Aspergillosis
Fusariosis
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases
Hyalohyphomycosis
Dermatomycoses
Skin Diseases, Infectious
Infection
Skin Diseases
Antifungal Agents
Miconazole
Caspofungin
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP3A Inhibitors


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