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Investigational Drug versus Amphotericin B for Empirical Therapy in Febrile, Neutropenic Pediatric Patients - Article


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Q Fever

Clinical Trial: Investigational Drug versus Amphotericin B for Empirical Therapy in Febrile, Neutropenic Pediatric Patients

This study is currently recruiting patients.

Sponsored by: Merck
Information provided by: Merck

Purpose

This study is a double-blind, randomized study of the investigational agent versus liposomal amphotericin B in the empirical treatment of pediatric patients (ages 2 through 17 years) who have an absolute neutrophil count (ANC) below 500/microliter and who have fever despite broad antibiotic coverage. Such patients would be candidates for empirical therapy with an intravenous anti-fungal agent.

Condition Treatment or Intervention Phase
Neutropenia
Fever
  
 Phase II
Phase III

MedlinePlus related topics:  Blood and Blood Disorders;   Fever

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Single Group Assignment, Safety Study

Eligibility

Ages Eligible for Study:  2 Years   -   17 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

  • Patients who are 2 through 17 years of age
  • Absolute Neutrophil Count (ANC) is below 500/microliter
  • Have persistent fever (at least 4 days) despite antibiotic therapy

Location and Contact Information

Toll Free Number      1-888-577-8839 

District of Columbia
      Call For Information, Washington,  District of Columbia,  20010,  United States; Recruiting

Illinois
      Call for Information, Chicago,  Illinois,  60614,  United States; Recruiting

Massachusetts
      Call for Information, Boston,  Massachusetts,  02115,  United States; Recruiting

Ohio
      Call for Information, Cleveland,  Ohio,  44106,  United States; Recruiting

Pennsylvania
      Call for Information, Philadelphia,  Pennsylvania,  19104,  United States; Recruiting

      Call For Information, Pittsburgh,  Pennsylvania,  15213,  United States; Recruiting

Tennessee
      Call for Information, Memphis,  Tennessee,  38105,  United States; Recruiting

      Call for Information, Nashville,  Tennessee,  37232,  United States; Recruiting

Texas
      Call For Information, Dallas,  Texas,  75390,  United States; Recruiting

Utah
      Call for Information, Salt Lake City,  Utah,  84132,  United States; Recruiting

More Information

Study ID Numbers:  0404ETPP
Record last reviewed:  March 2005
Last Updated:  March 18, 2005
Record first received:  May 11, 2004
ClinicalTrials.gov Identifier:  NCT00082537
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005


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October 10, 2008


Page Updated: November 22, 2004
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