A randomized, double-blind, placebo-controlled, exploratory study to assess the efficacy, safety, and tolerability of oral ARV-1801 given in combination with intravenous ceftazidime or meropenem for intensive phase therapy of melioidosis in hospitalized patients

Arrevus, Inc.0 个研究点目标入组 100 人开始时间: 2021年10月22日最近更新: 2021年11月1日

适应症

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•1. Patient must provide written informed consent obtained prior to any study-specific procedure being performed.
•2. Patient must be at least 18 years of age or older at time of consent.
•3. Patient must be hospitalized with suspected community-acquired melioidosis, meeting at least one of the criteria below:
•3.1 History of frequent contact with soil or surface water in an endemic area
•3.2 Presence of a known underlying risk factor such as diabetes, renal insufficiency or renal stones, thalassemia
•3.3 Special organ involvement such as splenic or hepatic abscess
•3.4 An illness compatible with melioidosis, including the presence of sepsis, acute pneumonia, acute pyelonephritis, septic arthritis, parotid disease or skin or soft tissue infection
•4. Patient must require intravenous antibiotics i.e., either ceftazidime or meropenem for treatment of suspected melioidosis.
•5. Patient must agree to stay in hospital for duration of ARV-1801 therapy, i.e., for at least 14 days.
•6. Females of childbearing potential must use an acceptable method of birth control (surgically sterile, intrauterine device, vasectomized partner, oral contraceptive plus barrier contraceptive, hormone delivery system plus barrier contraceptive or condom in combination with contraceptive cream, jelly or foam) for the duration of the study drug administration phase and for 30 days thereafter.

•1. Patient is unable to tolerate oral therapy, either directly or via a nasogastric tube.
•2. Patient has a known infection with an identified organism other than B. pseudomallei.
•3. Patient is pregnant or lactating.
•4. Patient has a known hypersensitivity to sodium fusidate, ceftazidime or meropenem.
•5. Patient has been treated with intravenous antibiotics active against B. pseudomallei (including ceftazidime and meropenem) for longer than 48 hours prior to randomization.
•6. Patient requires concomitant treatment with the following:
•6.1 OATP1B1 and OATP1B3 substrates, in particular statins (e.g., HMG-CoA reductase inhibitors)
•6.2 Medications metabolized by CYP2C8, such as glitazones (e.g., repaglinide)
•6.3 CYP3A4 inducers (e.g., dexamethasone, phenytoin, carbamazepine, rifampin, phenobarbital, and nafcillin)
•7. Patient has had prior treatment with a CYP3A4 inducer, such as dexamethasone, phenytoin, carbamazepine, rifampin, phenobarbital, or nafcillin, within 7 days prior to enrollment.
•8. Patient requires treatment with digoxin or warfarin unless a monitoring plan is in place to assess digoxin levels and/or prothrombin time as is relevant.

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