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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000001727 |
Receipt No. | R000002081 |
Scientific Title | Japanese multicenter study of short- and long-term efficacy and safety of itraconazole in the treatment of chronic necrotizing pulmonary aspergillosis |
Date of disclosure of the study information | 2009/02/23 |
Last modified on | 2011/04/21 |
Basic information | ||
Public title | Japanese multicenter study of short- and long-term efficacy and safety of itraconazole in the treatment of chronic necrotizing pulmonary aspergillosis | |
Acronym | Japanese multicenter study of itraconazole for chronic necrotizing pulmonary aspergillosis | |
Scientific Title | Japanese multicenter study of short- and long-term efficacy and safety of itraconazole in the treatment of chronic necrotizing pulmonary aspergillosis | |
Scientific Title:Acronym | Japanese multicenter study of itraconazole for chronic necrotizing pulmonary aspergillosis | |
Region |
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Condition | ||||
Condition | Chronic Necrotizing Pulmonary Aspergillosis | |||
Classification by specialty |
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Classification by malignancy | Others | |||
Genomic information | NO |
Objectives | |
Narrative objectives1 | 1) To verify short- and long-term efficacy and safety of itraconazole in the treatment of chronic necrotizing pulmonary aspergillosis
2) To measure the MIC of itraconazole against Aspergillus, and perform PK/PD analyses |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Confirmatory |
Trial characteristics_2 | Pragmatic |
Developmental phase | Not applicable |
Assessment | |
Primary outcomes | Clinical success rate |
Key secondary outcomes | 1) Safety
2) Isolation frequency (%) of each Aspergillus species through culture 3) MICs of antifungal agents against isolated Aspergillus strains 4) Correlation between MIC and clinical efficacy 5) Measurement of plasma concentration of itraconazole |
Base | |
Study type | Interventional |
Study design | |
Basic design | Single arm |
Randomization | Non-randomized |
Randomization unit | |
Blinding | Open -no one is blinded |
Control | Uncontrolled |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 1 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | Itraconazole | |
Interventions/Control_2 | ||
Interventions/Control_3 | ||
Interventions/Control_4 | ||
Interventions/Control_5 | ||
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Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | 1) Inclusion starts with admission to hospital regardless of whether an inpatient or outpatient
2) Meeting diagnostic criteria for clinical diagnosis or definitive diagnosis for respiratory medicinal CNPA described in "2007 Guideline for the diagnosis and treatment of profound mycosis" 3) Able to be followed up for at least 12 weeks 4) If pretreated with an antifungal agent, its use must have been continued for at least 1 month, with no tendency toward clinical improvement (antifungal agents are not specified) 5) Written informed consent obtained |
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Key exclusion criteria | 1) Pregnant or potentially pregnant women, or lactating women
2) Patients with any underlying diseases considered to have a significant impact on the course of treatment in this clinical study such as progressive cancer, serious heart failure, or serious respiratory failure 3) Patients with a stable lesion restricted to one area of the lung and considered a candidate for surgical resection 4) Patients receiving drugs contraindicated with itraconazole 5) Patients with history of hypersensitivity to itraconazole 6) Presence or history of serious liver disease 7) Patients with severe renal impairment (creatinine clearance < 30 mL/min) 8) Patients for whom inclusion in this clinical study is considered potentially disadvantageous 9) Patients who had been previously included in this study |
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Target sample size | 100 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | School of Medicine, Showa University | ||||||
Division name | Clinical infectious Diseases | ||||||
Zip code | |||||||
Address | 1-5-8 Hatanodai, Shinagawa-ku, Tokyo 142-8555 | ||||||
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Name of contact person |
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Organization | School of Medicine, Showa University | ||||||
Division name | Clinical infectious Diseases | ||||||
Zip code | |||||||
Address | 1-5-8 Hatanodai, Shinagawa-ku, Tokyo 142-8555 | ||||||
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Sponsor | |
Institute | Department of Clinical infectious Diseases, School of Medicine, Showa University |
Institute | |
Department |
Funding Source | |
Organization | Japan Association of Health Service |
Organization | |
Division | |
Category of Funding Organization | Non profit foundation |
Nationality of Funding Organization | Japan |
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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 |
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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 | |
Results date posted | |
Results Delayed | |
Results Delay Reason | |
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Baseline Characteristics | |
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Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Completed | ||||||
Date of protocol fixation |
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Anticipated trial start date |
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Date analysis concluded |
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Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002081 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |