Posaconazole Treatment of Invasive Fungal Infection (P05551) - Full Text View

Sponsor:	Schering-Plough
Information provided by:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00811642

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
Fungal Infection	Drug: Posaconazole	Phase III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Multicenter, Open Label Study to Evaluate Safety and Efficacy of Posaconazole Oral Suspension in Treatment of Invasive Fungal Infection

Resource links provided by NLM:

MedlinePlus related topics: Fungal Infections Molds

Drug Information available for: Posaconazole

U.S. FDA Resources

Further study details as provided by Schering-Plough:

Primary Outcome Measures:

Cumulative clinical effective rate at the end of POS treatment [ Time Frame: The maximum duration <=12 weeks since randomization ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Cumulative clinical effective rate at 4W, 8W of POS treatment [ Time Frame: The maximum duration <=12 weeks since randomization ] [ Designated as safety issue: No ]
Cumulative pathogenic fungal eradication rate at 4W, 8W and the end of POS treatment [ Time Frame: The maximum duration <=12 weeks since randomization ] [ Designated as safety issue: No ]
Cumulative survival rate at the end of POS treatment [ Time Frame: The maximum duration <=12 weeks since randomization ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	60
Study Start Date:	November 2008
Estimated Study Completion Date:	August 2010
Estimated Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental Posaconazole 400 mg BID	Drug: Posaconazole 40mg/ml, 400mg BID

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 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00811642

Contacts

Contact: SP Clinical Trial Registry Call Center

1-888-772-8734

Locations

China
Investigational Site 1	Recruiting
Beijing, China
Investigational Site 2	Recruiting
Beijing, China
Investigational Site 3	Recruiting
Beijing, China, 100853
Investigational Site 4	Recruiting
Tianjin, China
Investigational Site 10	Recruiting
Fuzhou, China
Investigational Site 7	Recruiting
Xi An, China
Investigational Site 9	Recruiting
Changsha, China
Investigational Site 6	Recruiting
Xi An, China

Sponsors and Collaborators

Schering-Plough

More Information

No publications provided

Responsible Party:	Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group )
Study ID Numbers:	P05551
Study First Received:	December 18, 2008
Last Updated:	February 8, 2010
ClinicalTrials.gov Identifier:	NCT00811642 History of Changes
Health Authority:	China: State Food and Drug Administration

Keywords provided by Schering-Plough:

refractory or first line medication intolerable invasive fungal infection

Additional relevant MeSH terms:

Trypanocidal Agents
Anti-Infective Agents
Mycoses
Communicable Diseases
Antiparasitic Agents
Antiprotozoal Agents

Therapeutic Uses
Antifungal Agents
Antibiotics, Antifungal
Posaconazole
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010