UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001786 |
|---|---|
| Receipt number | 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 18:07:38 |
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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
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
koizumik@nagasaki-u.ac.jp
Sponsor or person
Institute
NEOCI (Nagasaki Evaluation Organization for CLinical Interventions)
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002150
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