Phase 3
N=62
Posaconazole Treatment of Invasive Fungal Infection (IFI) (P05551)
Fungal Infection
Bottom Line
View on ClinicalTrials.gov: NCT00811642 ↗Enrolled (actual)
62
Serious AEs
8.1%
Results posted
Apr 2011
Primary outcome: Primary: Number of Participants Who Had Clinical Response at 12 Weeks With Posaconazole Treatment — 6; 32; 11; 10 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Posaconazole (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Mar 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Had Clinical Response at 12 Weeks With Posaconazole Treatment |
6; 32; 11; 10 | — |
| SECONDARY Number of Participants Who Had Clinical Response at 4 Weeks With Posaconazole Treatment |
2; 39; 11; 7 | — |
| SECONDARY Number of Participants Who Had Clinical Response at 8 Weeks With Posaconazole Treatment |
3; 34; 11; 11 | — |
| SECONDARY Number of Participants With Pathogenic Fungal Eradication at 4 Weeks With Posaconazole Treatment |
2; 6; 9 | — |
| SECONDARY Number of Participants With Pathogenic Fungal Eradication at 8 Weeks With Posaconazole Treatment |
2; 6; 9 | — |
| SECONDARY Number of Participants With Pathogenic Fungal Eradication at 12 Weeks With Posaconazole Treatment |
2; 7; 8 | — |
| SECONDARY Number of Participant Survivors at Week 14 of Post-Posaconazole Treatment Follow-up |
57; 2 | — |
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 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.
Data sourced from ClinicalTrials.gov (NCT00811642). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.