None listed
Conditions
Interventions
At Baseline/Day 1 subjects will be stratified into two strata
high risk or not high risk. Within each stratum, subjects will be randomly assigned to one of two possible treatment arms: POS or VOR for a total duration of therapy of 12 weeks. Subjects will be ra
POS=posaconazole
VOR=voriconazole
Sponsors
Merck Sharp & Dohme Corp., una subsidiaria de Merck & Co. Inc.,
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1 Each subject must be willing and able to provide written informed consent for the trial. 2 Be ≥13 years of age & weigh >40 kg and ≤150 kg at V2 or between 13 - 14 years & weigh ≥ 50. Either sex and any race/ethnicity 3 Meet the criteria for proven, probable, or possible IA as per 2008 EORTC/MSG disease definitions at V2 4 Subject with possible IA at V2 must be or be in process of an ongoing diagnostic work up which is anticipated to result in mycological diagnosis of proven or probable IA within 7 days postV2 5 Central line in place prior to begin IV study therapy 6 Acute IA 7 Adhere to dosing, study visit schedule & mandatory procedures: study therapy for up to 12 weeks and remain for 3-month follow-up 8 Ability to transition to oral study therapy during the course of the study or to receive the entire 12-week study treatment course IV 9 Fertile female subjects use an accepted method of birth control (MBC) before beginning study-drug treatment and continue its use for 30d after stopping the medication, or have been surgically sterilized. Barrier MBC is necessary if using oral or injectable hormonal contraception. If currently not sexually active, use one of the above methods if they become sexually active while in the study 10 Written IC for the pharmacogenetic testing (if participate in pharmacogenetic analysis) 11 Subject is not taking prohibited antifungal prophylaxis or treatment as defined by the protocol.
Exclusion criteria
Exclusion criteria: 1Chronic, relapsed/recurrent, or refractory IA which has not responded to prior antifungal treatment (tto) 2 Sarcoidosis, aspergilloma, or allergic bronchopulmonary aspergillosis 3 Mixed invasive mold fungal and/or invasive Aspergillus fungal infection where either study drug may not be considered active 4 Systemic antifungal therapy for 4 or more consecutive days prior to randomization. 5 IA infection during the receipt of more than 13 days of antifungal prophylaxis 6POS or VOR as empirical tto 7Prohibited tto more recent than washout period 8Condition that may interfere with study 9Hypersensitivity or other serious adverse reaction to azoles 10Female is pregnant or nursing 11History of arrhythmia or infaction 12QTc ≥ 500 msec 13 Liver dysfunction 14 Cirrhosis or Child-Pugh score of C 15 Renal insufficiency or on hemodialysis 16 Galactose intolerance, Lapp lactase deficiency, or GLU-GAL malabsorption 17 Prior acute symptomatic pancreatitis or chronic pancreatitis 18Active skin lesion consistent with squamous cell carcinoma or current or prior history of malignant melanoma 19Artificial ventilation 20Known or suspected Gilbert’s disease 21Tto with medication that cannot be stop and is contraindicated to coadministration of one or more of study drugs 22 Not wxpected to survive for at least 1 week postt-V2 23No prior enrollment in this or other POS study 24Subject or family member is among site or sponsor staff personnel
Countries
Argentina, Belgium, Brazil, Canada, Chile, China, Colombia, Estonia, France, Germany, Greece, Guatemala, India, Ireland, Israel, Italy, Korea South, Lithuania, Malasya, Mexico, Peru, Poland, Portugal, Russian Federation, Singapore, Spain, Switzerland, Taiwan, Turkey, United Kindgdom, United States
Contacts
Public ContactNelva Garcia
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed