Clinical trial NCT00811642: Posaconazole Treatment of Invasive Fungal Infection (IFI) (P05551)
Official title: A Multicenter, Open Label Study to Evaluate Safety and Efficacy of Posaconazole Oral Suspension in Treatment of Invasive Fungal Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Fungal Infection
Keywords: refractory or first line medication intolerable invasive fungal infection
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-12-19
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Number of Participants Who Had Clinical Response at 12 Weeks With Posaconazole Treatment
timeFrame: Treatment week 12
Secondary outcomes:
measure: Number of Participants Who Had Clinical Response at 4 Weeks With Posaconazole Treatment
timeFrame: Treatment week 4
measure: Number of Participants Who Had Clinical Response at 8 Weeks With Posaconazole Treatment
timeFrame: Treatment week 8
measure: Number of Participants With Pathogenic Fungal Eradication at 4 Weeks With Posaconazole Treatment
timeFrame: Treatment week 4
measure: Number of Participants With Pathogenic Fungal Eradication at 8 Weeks With Posaconazole Treatment
timeFrame: Treatment week 8
measure: Number of Participants With Pathogenic Fungal Eradication at 12 Weeks With Posaconazole Treatment
timeFrame: Treatment week 12
measure: Number of Participant Survivors at Week 14 of Post-Posaconazole Treatment Follow-up
timeFrame: Follow-up week 14
Other outcomes:
Locations:
Study officials:
References:
citation: Huang X, Wang F, Chen Y, Liu T, Wang J, Hu J, Jie J, Chen F, Wang S, Shen Z, Yu L, Yu K, Liang Y. A multicenter, open-label study of posaconazole oral suspension in the treatment of invasive fungal infections in patients refractory to or intolerant of first-line therapy. Future Microbiol. 2012 Feb;7(2):201-9. doi: 10.2217/fmb.11.158.