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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001786
Receipt No. R000002150
Scientific Title Intravenous micafungin versus intravenous voriconazole for chronic necrotizing pulmonary aspergillosis: a multicenter, open-labeled, non-inferiority trial in Japan
Date of disclosure of the study information 2009/03/19
Last modified on 2009/11/11

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Basic information
Public title Intravenous micafungin versus intravenous voriconazole for chronic necrotizing pulmonary aspergillosis: a multicenter, open-labeled, non-inferiority trial in Japan
Acronym Comparison study between MCFG and VRCZ for CNPA
Scientific Title Intravenous micafungin versus intravenous voriconazole for chronic necrotizing pulmonary aspergillosis: a multicenter, open-labeled, non-inferiority trial in Japan
Scientific Title:Acronym Comparison study between MCFG and VRCZ for CNPA
Region
Japan

Condition
Condition Chronic necrotizing pulmonary aspergillosis
Classification by specialty
Infectious disease
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Comparison of efficacy of MCFG and VRCZ against chronic necrotizing pulmonary aspergillosis
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Efficacy of drugs after administration of two weeks
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Administration of antifungal drugs (MCFG)
Interventions/Control_2 Administration of antifungal drugs (VRCZ)
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key 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.
Key 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).
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shigeru Kohno
Organization Nagasaki University Graduate School of Biomedical Sciences
Division name Department of Molecular Microbiology and Immunology
Zip code
Address 1-7-1 Sakamoto, Nagasaki 852-8501, JAPAN
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Koichi Izumikawa
Organization Nagasaki University Graduate School of Biomedical Sciences
Division name Department of Molecular Microbiology and Immunology
Zip code
Address
TEL
Homepage URL
Email koizumik@nagasaki-u.ac.jp

Sponsor
Institute NEOCI (Nagasaki Evaluation Organization for CLinical Interventions)
Institute
Department

Funding Source
Organization NEOCI (Nagasaki Evaluation Organization for CLinical Interventions)
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2009 Year 03 Month 19 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
The total of 50 and 47 patients were assigned to the MCFG and VRCZ groups, respectively. At enrollment, the two groups did not significantly differ in demographics or baseline characteristics, such as age, sex, weight, height, previous history of treatment of aspergillosis, SpO2, and other findings of inflammation makers. The difference in efficacy rates between MCFG and VRCZ was not significant, either after 2 weeks [68.0% vs. 58.7%; the absolute difference, 9.3% with a 95% confidence interval (CI), -9.97 to 28.58, P=0.344] or at the end of therapy (60.0% vs. 53.2%; the absolute difference, 6.8% with a 95% CI, -12.92 to 26.54, P=0.499). In the safety evaluation (MCFG, n=53, VRCZ, n=54), fewer adverse events occurred in the MCFG than VRCZ group (26.4% vs. 61.1%, P=0.0004). The incidence of adverse events not including visual events in the VRCZ was significantly lower in MCFG than VRCZ group (26.4% vs. 50.0%, P=0.017). Additionally, fewer patients in the MCFG group had hepatic dysfunction (15.1% vs. 35.2%, P=0.025).
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2006 Year 03 Month 31 Day
Date of IRB
Anticipated trial start date
2006 Year 04 Month 01 Day
Last follow-up date
2008 Year 07 Month 01 Day
Date of closure to data entry
2009 Year 03 Month 01 Day
Date trial data considered complete
2009 Year 03 Month 01 Day
Date analysis concluded
2009 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 03 Month 19 Day
Last modified on
2009 Year 11 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002150

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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