Clinical Study of AK1820 (Isavuconazonium Sulfate) for the Treatment of Deep Mycosis
Deep Mycosis
About this trial
This is an interventional treatment trial for Deep Mycosis focused on measuring deep mycosis, aspergillosis, mucormycosis, cryptococcosis, isavuconazonium sulfate, isavuconazole, AK1820, Cresemba
Eligibility Criteria
Main Inclusion Criteria:
Patients must have the below proven, probable or possible deep mycosis;
- invasive aspergillosis
- chronic pulmonary aspergillosis
- mucormycosis
- cryptococcosis
- Female patients must be non-lactating and at no risk for pregnancy.
Main Exclusion Criteria:
- Women who are pregnant or breastfeeding.
- Patients with hypersensitivity to any of the components of the azole class of antifungals or the investigational product.
- Patients at high risk for QT/QTc prolongation, or patients with risk factors for torsades de pointes, or taking concomitant medications known to prolong the QT/QTc interval.
- Patients with a history of short QT syndrome.
- Patients with liver dysfunction at enrollment.
- Patients with moderate to severe kidney dysfunction at enrollment.
- Patients who receive prohibited concomitant drugs.
- Patients with any other fungal infection other than Aspergillus species, order Mucorales, or Cryptococcus species.
- Patients who are not expected to survive study duration.
- Patients with an underlying disease, complication or general condition that would complicate safety and efficacy evaluations.
- Patients with a history of taking voriconazole for deep mycosis and showing no response to this treatment.
- Patients taking systemic antifungals who are unable to stop taking these drugs during the study, or who are showing signs of improvement in their symptoms of deep mycosis as a result of these drugs.
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
AK1820
Voriconazole
Participants will receive a loading dose of isavuconazole, 200 mg three times a day by intravenous infusion (IV) or orally for the first 2 days followed by a maintenance dose from Day 3 of 200 mg once daily either IV or orally until they will reach a treatment endpoint or for a maximum of 84 days.
Participants will receive a loading dose of voriconazole, 6 mg/kg every 12 hours IV or 300 mg every 12 hours orally for the first 24 hours, followed by a maintenance dose from Day 2 of 4 mg/kg every 12 hours by IV or 200 mg every 12 hours orally, until they will reach a treatment endpoint or for a maximum of 84 days.