A Study to Evaluate the Efficacy and Safety of Micafungin Against Invasive Candidiasis or Candidemia

• Status: Terminated
• Trial end date: 2015-08-28
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the efficacy and safety of intravenous micafungin for the treatment of patients with proven or probable fungal infections caused by Candida sp. (Fungemia, respiratory mycosis, gastrointestinal mycosis) in adult patients in China.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma China, Inc.
• Treatments: Echinocandins; Micafungin

Criteria

Inclusion Criteria:

• The diagnosis criteria of probable candida infection: Risk factors + Clinical Manifestations + positive findings including microbiologic test

• The diagnosis criteria of proven candida infection: Risk factors + Clinical Manifestation + positive findings including microbiologic test + tissue culture or pathological examination results

• The following 3 criteria must be met is a patient is diagnosed as probable candida pneumonia:

1. Risk factor (s) of infection

2. Clinical manifestations of infection and the pulmonary infection cannot be explained by other pathogenic infections

3. Two or more positive sputum culture for Candida

Exclusion Criteria:

• Patient received any other antifungal drug within 1 month prior to enrollment.

• HIV positive patient

• Patients with organ transplant

• Patients with agranulocytosis