A Randomized, Open Label Parallel Controlled, Multicenter Study to Evaluate Safety and Efficacy of Posaconazole Oral Suspension Vs. Fluconazole (Capsule) in High-risk Leukopenic Patients for Prevention of Invasive Fungal Infection

Merck Sharp & Dohme LLC0 sites252 target enrollmentNovember 2008

ConditionsLeukopenia

InterventionsPosaconazole Fluconazole

DrugsPosaconazole Fluconazole

Overview

Phase: Phase 3
Intervention: Posaconazole
Conditions: Leukopenia
Sponsor: Merck Sharp & Dohme LLC
Enrollment: 252
Primary Endpoint: Number of Participants With Proven or Probable Diagnosis of Invasive Fungal Infection (IFI) During the Treatment Period
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

A randomized, open label parallel controlled, multicenter study to evaluate safety and efficacy of Posaconazole oral suspension vs Fluconazole (capsule) in high-risk leukopenic patients for prevention of invasive fungal infection

Registry

clinicaltrials.gov

Start Date

November 2008

End Date

May 2010

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Merck Sharp & Dohme LLC

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Participants must be 18-70 years of age of either sex
•Persistent neutropenia (Absolute Neutrophil Count \[ANC\] \< 500/mm\^3 \[0.5x10\^9/L\]）or probable neutropenia in 3-5 days is anticipated. Neutropenia \>= 7 days caused by the following reasons
•Standard or dose-intense chemotherapy, anthracyclines or other acceptable chemotherapies ( any investigational drug is not permitted) for Acute Myelogenous Leukemia (AML) treatment
•Retreatment of chemotherapy in case of AML recurrence
•Myelodysplastic syndrome (MDS) shifts to AML and bone marrow arrest induction chemotherapy is required (not including acute phase of chronic myelogenous leukemia \[CML\])
•Informed consent obtained from participant or legal guardian

Exclusion Criteria

•Participants previously treated with amphotericin B (AMB), fluconazole (FLZ), or itraconazole (ITZ) within 30 days of enrollment.
•Participants who have taken the following drugs:
•terfenadine, cisapride, and ebastine within 24 hours before entry
•astemizole at entry or within 10 days before entry
•cimetidine, rifampin, carbamazepine, phenytoin, rifabutin, barbiturates, isoniazid atharanthine and anthracyclines within 24 hours before entry
•The above drugs are refrained during the investigation
•Serious organ diseases except hematological disorder such as cardiac or neurologic disorders or impairment expected to be unstable or progressive during the course of this study (eg, seizures or demyelinating syndromes, acute myocardial infarction within 3 months of study entry, myocardial ischemia, congestive heart failure, atrial fibrillation with ventricular rate \<60/min, or history of torsades de pointes, symptomatic ventricular or sustained arrhythmias), unstable electrolyte abnormalities.
•Participants who have used any investigational drugs or biologic agents other than their chemotherapy regimens within 30 days of study entry.
•Prior enrollment in this study.
•Participants with known or suspected hypersensitivity or idiosyncratic reaction to azole agents or amphotericin B.

Arms & Interventions

Posaconazole

Posaconazole oral suspension 200 mg three times a day (TID)

Intervention: Posaconazole

Fluconazole

Fluconazole 400 mg once daily (QD)

Intervention: Fluconazole

Outcomes

Primary Outcomes

Number of Participants With Proven or Probable Diagnosis of Invasive Fungal Infection (IFI) During the Treatment Period

Time Frame: Up to 12 Weeks (84 days) plus 7 days

Number of participants developing a proven or probable IFI from randomization to the last dosage date (up to 12 weeks \[84 days\]) plus 7 days. IFI diagnosis criteria may include: persistent fever, failure of appropriate broad-spectrum antibiotic treatment concomitant with lower respiratory tract infection symptoms, microbiological criteria with corresponding clinical signs and symptoms.

Secondary Outcomes

Time From Randomization to Administration of First Systemic Antifungal Intravenous (IV) Therapy(Up to 12 weeks (84 days))
Number of Participants With Clinical Failure During Treatment(Up to 12 weeks (84 days))
Number of Participants in Whom All-cause Mortality Occurred Within 100 Days From Randomization(Randomization date to Day 100)
Number of Participants in Whom Mortality is Unlikely, Possibly, and Probably Related to Fungal Infection Occurred Within 100 Days From Randomization(From randomization date to Day 100)
Number of Participants With Proven or Probable Diagnosis of IFI Within 100 Days From Randomization(From randomization date to Day 100)
Time From Randomization to the First Onset of Proven or Probable IFI(From randomization date to Day 100)