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

Merck Sharp & Dohme LLC0 sites63 target enrollmentNovember 2008

ConditionsFungal Infection

InterventionsPosaconazole

DrugsPosaconazole

Overview

Phase: Phase 3
Intervention: Posaconazole
Conditions: Fungal Infection
Sponsor: Merck Sharp & Dohme LLC
Enrollment: 63
Primary Endpoint: Number of Participants Who Had Clinical Response at 12 Weeks With Posaconazole Treatment
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

The purpose of this multicenter, open label study, is to evaluate the safety and efficacy of a 12-week treatment with Posaconazole Oral Suspension in participants with IFI

Registry

clinicaltrials.gov

Start Date

November 2008

End Date

March 2010

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Merck Sharp & Dohme LLC

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Participants must be 18-70 years male or female
•Identified or clinically diagnosed IFI participants 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 participants who are pregnant or are nursing.
•Participants with known or suspected hypersensitivity or idiosyncratic reaction to azole agents or amphotericin B
•Participants with progressive nervous system diseases( excluding those IFI caused)
•Participants who take the following drugs known with interference with azole antifungal preparations
•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 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.
•Participants having an ECG with a prolonged QTc interval: QTc greater than 450 msec for men and greater than 470 msec for women.

Arms & Interventions

Posaconazole

Posaconazole 400 mg twice a day (BID) oral suspension for 12 weeks

Intervention: Posaconazole

Outcomes

Primary Outcomes

Number of Participants Who Had Clinical Response at 12 Weeks With Posaconazole Treatment

Time Frame: Treatment week 12

EVALUATION OF PARTICIPANTS' CLINICAL RESPONSE BASED ON CRITERIA: Complete Response: resolution of Invasive Fungal Infection (IFI) attributable symptoms, signs and laboratory or etiological abnormalities, if present at enrollment. Partial Response: clinically significant improvement in IFI attributable symptoms, signs and laboratory or etiological abnormalities, if present at enrollment, of which, one still had not achieved complete recession. Stable disease: no progress in IFI attributable symptoms, if present at enrollment. Failure: deterioration in IFI attributable clinical symptoms.

Secondary Outcomes

Number of Participants Who Had Clinical Response at 4 Weeks With Posaconazole Treatment(Treatment week 4)
Number of Participants Who Had Clinical Response at 8 Weeks With Posaconazole Treatment(Treatment week 8)
Number of Participants With Pathogenic Fungal Eradication at 4 Weeks With Posaconazole Treatment(Treatment week 4)
Number of Participants With Pathogenic Fungal Eradication at 8 Weeks With Posaconazole Treatment(Treatment week 8)
Number of Participants With Pathogenic Fungal Eradication at 12 Weeks With Posaconazole Treatment(Treatment week 12)
Number of Participant Survivors at Week 14 of Post-Posaconazole Treatment Follow-up(Follow-up week 14)