Assessing the Safety and Efficacy of MK-5592 (Posaconazole) in Japanese Participants With Fungal … (NCT02180165) | Clinical Trial Compass
CompletedPhase 3
Assessing the Safety and Efficacy of MK-5592 (Posaconazole) in Japanese Participants With Fungal Infection (MK-5592-101)
116 participantsStarted 2014-07-29
Plain-language summary
The primary objective of this study is to assess and compare the safety of posaconazole with voriconazole in Japanese participants with aspergillosis.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Body weight \>=45 kg
* Can be treated by taking tablet orally or intravenous (IV) formulation via central vein
* Female has a negative pregnancy test
* Female of non-childbearing potential; or if of childbearing potential, agrees to use proper combination of barrier method of birth control
* Met screening criteria for either Invasive aspergillosis, chronic pulmonary aspergillosis, zygomycosis or fusariosis.
Exclusion Criteria:
* Has a fungal infection other than Aspergillus any species (spp.) Zygomycetes (including Mucor spp.) and Fusarium spp. infection
* Has allergic bronchopulmonary aspergillosis, allergic sinusitis of aspergillosis, or aspergillosis of the eye
* Has long-term inactive aspergilloma not expected to respond to investigational product
* Is not expected to survive study duration
* Has an underlying disease, complication and systemic condition which makes it difficult to evaluate effect of study drug
* Has received, or continues to receive any systemic antifungal therapy, and cannot discontinue this treatment; but if fungal infection does not improve, can switch to study drug
* Is expected to need prohibited medications
* Has received posaconazole, has received voriconazole for this infection in the past and has deep-seated fungal infection that has not responded to this treatment, has intolerance for azole antifungal treatments, or is receiving antifungal combination therapy for chronic pulmonary aspergillosis
* Has known hypersensitiv…