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

Astellas

Status and phase: Terminated; Phase 4

Conditions: Candidemia; Candidiasis

Treatments: Drug: Micafungin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01982071

ACN-MA-MYC-IC-2012

Details and patient eligibility

About

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.

Enrollment: 59 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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59 participants in 1 patient group

Treatment group

Experimental group

Description:

Intravenous (IV)

Treatment:

Drug: Micafungin