Posaconazole Treatment of Invasive Fungal Infection (P05551)

Condition(s) targeted: Fungal Infection

Intervention: Posaconazole (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Schering-Plough

Overall contact:
SP Clinical Trial Registry Call Center, Phone: 1-888-772-8734

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.

Official title: A Multicenter, Open Label Study to Evaluate Safety and Efficacy of Posaconazole Oral Suspension in Treatment of Invasive Fungal Infection

Study design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study

Primary outcome: Cumulative clinical effective rate at the end of POS treatment

Secondary outcome:

Cumulative clinical effective rate at 4W, 8W of POS treatment

Cumulative pathogenic fungal eradication rate at 4W, 8W and the end of POS treatment

Cumulative survival rate at the end of POS treatment

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Subjects must be 18-70 years male or female patients

- Identified or clinically diagnosed IFI patients or high risk population who are

resistant to, or recurrent from, or intolerable to, or may suffer toxic reaction from standard antifungal treatment.

- Sign informed consent form

Exclusion Criteria:

- Female subjects who are pregnant or are nursing.

- Subjects with known or suspected hypersensitivity or idiosyncratic reaction to azole

agents or amphotericin B

- Subjects with progressive nervous system diseases( excluding those IFI caused)

- Subjects who take the following drugs known with interference with azole antifungal

preparations

- terfenadine, cis apride, 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 drugs listed above are prohibited 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.

- Subjects having an ECG with a prolonged QTc interval: QTc greater than 450 msec for

men and greater than 470 msec for women.

- Expected to take during investigation or is taking systemic antifungal treatment

- 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 expected to survive no more than 72hrs

- Subjects receiving artificial aeration and will not withdraw within 24hrs

- Subjects who have used any investigational drugs or biologic agents or anticipated

other clinical trials within 30 days of study entry.

- Prior enrollment in this study.

- History of alcohol and/or drug abuse.

- Subjects cannot be compliant in investigator's opinion.

SP Clinical Trial Registry Call Center, Phone: 1-888-772-8734

Investigational Site 1, Beijing, China; Recruiting

Investigational Site 2, Beijing, China; Recruiting

Investigational Site 3, Beijing 100853, China; Recruiting

Investigational Site 4, Tianjin, China; Recruiting

Investigational Site 6, Xi An, China; Recruiting

Investigational Site 7, Xi An, China; Recruiting

Investigational Site 9, Changsha, China; Recruiting

Investigational Site 10, Fuzhou, China; Recruiting

Starting date: November 2008
Ending date: February 2010
Last updated: September 14, 2009