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



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

For Condition: Fever,Neutropenia
Status: Not yet recruiting
Sponsor(s): Sponsor Name Pending ,
Synopsis: 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.
Details:
Eligibility:
Study Type:
  Interventional, Treatment, Randomized, Double-Blind, Active Control, Single Group Assignment, Safety Study
Minimum Age/Maximum Age: 2 Years/17 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - Patients who are 17 years of age - Absolute Neutrophil Count (ANC) is below 500/microliter - Have persistent fever (at least 4 days) despite antibiotic therapy
Total Enrollment: 

Location and Contact Information:


Additional Information:
Study ID Numbers:
  0404ETPP; 
Study Start Date: 
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00082537

Other Neutropenia Studies:
1. Phase I Study of the Safety, Tolerance, and Pharmacokinetics of FK463 in Immunocompromised Children with Fever and Neutropenia

2. Investigating Anidulafungin in Children with Fever and Neutropenia

3. Investigational Drug versus Amphotericin B for Empirical Therapy in Febrile, Neutropenic Pediatric Patients

4. Treatment of neutropenic patients with fever who are suspected to have a gram positive infection (a specific kind of bacteria)

5. A Prospective, Randomized, Phase III Trial of FLAC (5-Fluorouracil, Leucovorin, Adriamycin, Cytoxan) Chemotherapy with GM-CSF (Granulocyte-Macrophage Colony-Stimulating Factor) Versus PIXY 321 in Advanced Breast Cancer

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