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Intravenous micafungin versus intravenous voriconazole for chronic necrotizing pulmonary aspergillosis: a multicenter, open-labeled, non-inferiority trial in Japan

Intravenous micafungin versus intravenous voriconazole for chronic necrotizing pulmonary aspergillosis: a multicenter, open-labeled, non-inferiority trial in Japan - Comparison study between MCFG and VRCZ for CNPA

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000001786
Enrollment
150
Registered
2009-03-19
Start date
2006-04-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic necrotizing pulmonary aspergillosis

Interventions

Administration of antifungal drugs (MCFG) Administration of antifungal drugs (VRCZ)

Sponsors

NEOCI (Nagasaki Evaluation Organization for CLinical Interventions)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients were eligible for enrolment if they were at least 20 years or older and diagnosed as CNPA. The diagnostic criteria for CNPA by Hope et al. with modification were used in this study. CNPA Patients fulfilled with following conditions; (1) existing al least one of symptom complex consisting of fever, weight loss, sputum, cough, hemoptysis, fatigue and shortness of breath. A criteria of CNPA was considered to be certain if it was associated with the following conditions; (2) New infiltrates or cavity formation or expansion of pre-existing cavities with or without peri-cavitary infiltrates and adjacent pleural thickening; (3) at least one positive result of serologic tests including Aspergillus antigen test, antibody test and/or any positive evidences if existence of Aspergillus species by molecular diagnosis, culture positive and pathological findings, (4) positive findings of at least one of the inflamation markers such as white blood cell (WBC) counts, value of C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR), (5) non-improvement of symptoms to at least 3 days-administration of wide-broad antibiotics.

Exclusion criteria

Exclusion criteria: The following patients were excluded from the study: (1) patients received MCFG or VRCZ within a month at the time of the diagnosis of CNPA, (2) patients with simple aspergilloma, invasive pulmonary aspergillosis, or allergic bronchopulmonary aspergillosis, (3) patients with infectious diseases other than Aspergillosis, (4) pregnant patients, (5) patients without informed consent, and (6) patients with liver, kidney and heart failure (more than Grade II in CTCAEv3.0).

Design outcomes

Primary

MeasureTime frame
Efficacy of drugs after administration of two weeks

Countries

Japan

Contacts

Public ContactKoichi Izumikawa

Nagasaki University Graduate School of Biomedical Sciences Department of Molecular Microbiology and Immunology

koizumik@nagasaki-u.ac.jp

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026