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Safety and Efficacy Study of Posaconazole vs. Fluconazole for Prevention of Invasive Fungal Infection (P05387)
This study is currently recruiting participants.
Verified by Schering-Plough, August 2009
First Received: December 18, 2008   Last Updated: August 14, 2009   History of Changes
Sponsored by: Schering-Plough
Information provided by: Schering-Plough
ClinicalTrials.gov Identifier: NCT00811928
  Purpose

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


Condition Intervention Phase
Leukopenia
Drug: Posaconazole
Drug: Fluconazole
Phase III

Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Schering-Plough:

Primary Outcome Measures:
  • Incidence of proven or clinical IFI during treatment [ Time Frame: Randomization date to last dosage date plus 7days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of proven or clinical IFI from randomization date to Day 100 [ Time Frame: From randomization date to Day100 ] [ Designated as safety issue: No ]
  • The first occurrence of proven or clinical IFI from randomization [ Time Frame: From randomization date to Day100 ] [ Designated as safety issue: No ]
  • The first application of systematic anti-fungal treatment from randomization [ Time Frame: From randomization date to Day 100 ] [ Designated as safety issue: No ]
  • Clinical failure rate during treatment [ Time Frame: From randomization date to Day 100 ] [ Designated as safety issue: No ]
  • All-cause mortality rate in 100 days [ Time Frame: From randomization date to Day 100 ] [ Designated as safety issue: Yes ]
  • Mortality rate related to fungal infection in 100 days [ Time Frame: From randomization date to Day 100 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 240
Study Start Date: November 2008
Estimated Study Completion Date: February 2010
Estimated Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A: Active Comparator
Posaconazole 200 mg TID
Drug: Posaconazole
40mg/ml, 200mg TID
B: Active Comparator
Fluconazole 400mg QD
Drug: Fluconazole
50mg/capsule;150mg/capsule; 400mg QD

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects must be 18-70 years of age of either sex;
  • Persistent neutropenia (ANC < 500/mm3 [0.5x109/L])or, probable neutropenia in 3-5 days is anticipated.

Neutropenia caused by the following reasons prolongs >=7days.

  • Standard or dose-intense chemotherapy, anthracyclines or other acceptable chemotherapies ( any investigational drug is not permitted) for AML treatment
  • Retreatment of chemotherapy in case of AML recurrence
  • MDS shifts to AML and bone marrow arrest induction chemotherapy is required ( not including acute phase of CML)

    • Informed consent obtained from subject or legal guardian

Exclusion Criteria:

  • Subjects previously treated with AMB, FLZ, or ITZ within 30 days of enrollment.
  • Subjects 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 deseases 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.
  • Subjects 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.
  • Subjects with known or suspected hypersensitivity or idiosyncratic reaction to azole agents or amphotericin B.
  • Subjects with known or suspected IFI at screen
  • Subjects with severe renal insufficiency (estimated creatinine clearance less than 50 mL/minute or likely to require dialysis during the study), ALT,AST AKP or total bilirubin are >2×ULN.
  • Subjects having an ECG with a prolonged QTc interval: QTc greater than 450 msec for men and greater than 470 msec for women.
  • Subjects with AML or CML history.
  • Subjects with a history of allogeneic hematopoietic stem cell, bone marrow transplantation, autologous stem cell transplantation history.
  • Female subjects who are pregnant or are nursing.
  • Alcohol and/or drug abuse.
  • Subjects cannot be compliant in the opinion of the investigator.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00811928

Contacts
Contact: SP Clinical Trial Registry Call Center 1-888-772-8734

Locations
China
Investigational Site 1 Recruiting
Beijing, China, 100044
Sponsors and Collaborators
Schering-Plough
  More Information

No publications provided

Responsible Party: Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group )
Study ID Numbers: P05387
Study First Received: December 18, 2008
Last Updated: August 14, 2009
ClinicalTrials.gov Identifier: NCT00811928     History of Changes
Health Authority: China: State Food and Drug Administration

Keywords provided by Schering-Plough:
high-risk leukopenic patients

Study placed in the following topic categories:
Fluconazole
Anti-Bacterial Agents
Anti-Infective Agents
Mycoses
Hematologic Diseases
Antifungal Agents
Leukocyte Disorders
Posaconazole
Leukopenia

Additional relevant MeSH terms:
Fluconazole
Anti-Infective Agents
Trypanocidal Agents
Antiprotozoal Agents
Hematologic Diseases
Leukocyte Disorders
Pharmacologic Actions
Mycoses
Antiparasitic Agents
Antifungal Agents
Therapeutic Uses
Antibiotics, Antifungal
Leukopenia
Posaconazole

ClinicalTrials.gov processed this record on September 03, 2009