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

This study has been terminated.
(Low accrual)
Sponsor:
Collaborator:
Federal University of São Paulo
Information provided by (Responsible Party):
Marcio Nucci, Federal University of Rio de Janeiro
ClinicalTrials.gov Identifier:
NCT00982540
First received: September 22, 2009
Last updated: January 28, 2014
Last verified: January 2014
  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 Universidade Federal do 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 ]

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

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: September 22, 2009
Last Updated: January 28, 2014
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Universidade Federal do Rio de Janeiro:
empiric antifungal therapy
preemptive antifungal therapy
febrile neutropenia
risk stratification
invasive fungal infection

Additional relevant MeSH terms:
Aspergillosis
Mycoses
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 July 20, 2014