Posaconazole Treatment of Invasive Fungal Infection (IFI) (P05551)
Condition: Fungal Infection
MeSH terms: Infections; Communicable Diseases; Mycoses; Invasive Fungal Infections
Intervention: Posaconazole
Intervention description: 400mg BID oral suspension for 12 weeks
Intervention MeSH terms: Posaconazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 63.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: refractory or first line medication intolerable invasive fungal infection

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
    

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.

          -  Expected to take during investigation or is taking systemic antifungal treatment

          -  Participants 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.

          -  Participants expected to survive no more than 72hrs

          -  Participants receiving artificial aeration and will not withdraw within 24hrs

          -  Participants 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.

          -  Participants cannot be compliant in investigator's opinion.