A PHASE 3 RANDOMIZED STUDY OF THE EFFICACY AND SAFETY OF POSACONAZOLE VERSUS VORICONAZOLE FOR THE TREATMENT OF INVASIVE ASPERGILLOSIS IN ADULTS (PHASE 3; PROTOCOL NO. MK-5592-069)

Merck Sharp & Dohme Corp., una subsidiaria de Merck & Co. Inc.,0 个研究点目标入组 6 人开始时间: 2014年6月25日最近更新: 2023年9月4日

适应症

试验速览

暂无简介。

•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
•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.

•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

发起方

Merck Sharp & Dohme Corp., una subsidiaria de Merck & Co. Inc.,