Conditions: Fungal Infection
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 63
Healthy volunteers: no

Brief summary:
To evaluate the safety, tolerability, and efficacy of caspofungin for the treatment of esophageal candidiasis and invasive candidiasis to support the registration of caspofungin for these indications in China.

Detailed description:

Arms:
arm 1: None

Interventions: intervention 1: caspofungin acetate
Intervention descriptions: intervention 1: Intravenous (IV) caspofungin acetate 50 mg/day. Participants with esophageal candidiasis will be treated for at least 7 days and for at least 72 hours after symptoms resolve for a maximum of 28 days; participants with invasive candidiasis will have a 70 mg loading dose on study day 1 and will be treated for at least 14 days after the last positive culture of Candida from the blood or other normally sterile body site for a maximum of 60 days; these participants should also have improvement in clinical and radiographic signs of disease for at least 48 hours before completion of the study therapy.

Protocol document: