UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007055 |
|---|---|
| Receipt number | R000008316 |
| Scientific Title | Retrospective Research for Chronic Pulmonary Aspergillosis |
| Date of disclosure of the study information | 2012/01/13 |
| Last modified on | 2021/07/20 10:55:37 |
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Basic information
Public title
Retrospective Research for Chronic Pulmonary Aspergillosis
Acronym
Retrospective Research for CPA
Scientific Title
Retrospective Research for Chronic Pulmonary Aspergillosis
Scientific Title:Acronym
Retrospective Research for CPA
Region
| Japan |
Condition
Condition
chronic pulmonary aspergillosis
Classification by specialty
| Medicine in general | Pneumology | Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate retrospectively maintenance therapy after acute-phase treatment and long-term prognosis of patient with chronic pulmonary aspergillosis. Information will be collected to support revision for the guideline of deep-seated mycosis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) Prognosis of CPA: Calculate one year and two year survival rate
2) Maintenance therapy after acute-phase treatment
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
Patient who was diagnosed with CPA according to following criteria and was registered in previously conducted clinical study as NEOCI-0001(UMIN 000001786) or NEOCI-0002 (UMIN 000002236).
(1) Chronic respiratory symptom or systemic symptom; i.e. the existence of at least one of the symptoms of fever, weight loss, sputum, cough, hemoptysis, fatigue, and dyspnea
(2) New infiltrates or cavity formation or expansion of pre-existing cavities with or without peri-cavitary infiltrates and adjacent pleural thickening in last six months.
(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 inflammation 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 systemic antibiotics (exclusion of respiratory infection with CPA like clinical condition).
Key exclusion criteria
Patient who had not been registered to NEOCI-0001(UMIN 000001786) or NEOCI-0002 (UMIN 000002236)
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Shigeru |
| Middle name | |
| Last name | Kohno |
Organization
Nagasaki University Graduate School of Biomedical Sciences
Division name
Department of Molecular Microbiology and Immunology
Zip code
852-8501
Address
1-7-1, Sakamoto, Nagasaki, JAPAN
TEL
095-819-7273
s-kohno@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Koichi |
| Middle name | |
| Last name | Izumikawa |
Organization
Nagasaki University Graduate School of Biomedical Sciences
Division name
Department of Molecular Microbiology and Immunology
Zip code
852-8501
Address
1-7-1, Sakamoto, Nagasaki, JAPAN
TEL
095-819-7273
Homepage URL
koizumik@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki evaluation organization for clinical interventions
Institute
Department
Personal name
Funding Source
Organization
Nagasaki evaluation organization for clinical interventions
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagasaki University Hospital
Address
1-7-1, Sakamoto, Nagasaki
Tel
095-819-7731
n/a
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
長崎大学病院（長崎県） 他
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 01 | Month | 13 | Day |
Related information
URL releasing protocol
https://rctportal.niph.go.jp/s/detail/um?trial_id=UMIN000007055
Publication of results
Published
Result
URL related to results and publications
doi: 10.1093/cid/ciz287.
Number of participants that the trial has enrolled
273
Results
Of the 273 CPA patients, 59 and 101 patients started maintenance therapy with oral ITCZ and oral VRCZ, respectively,
just after the end of acute intravenous therapy in each trial.
Results date posted
| 2021 | Year | 07 | Month | 20 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2019 | Year | 04 | Month | 08 | Day |
Baseline Characteristics
Of the 273 CPA patients, 59 and 101 patients started maintenance therapy with oral ITCZ and oral VRCZ, respectively,
just after the end of acute intravenous therapy in each trial.
Participant flow
We conducted a retrospective, follow-up, observational study of CPA patients enrolled in 2 previous multicenter trials
Adverse events
n/a
Outcome measures
n/a
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2011 | Year | 08 | Month | 02 | Day |
Date of IRB
| 2012 | Year | 01 | Month | 05 | Day |
Anticipated trial start date
| 2012 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
retrospective
Management information
Registered date
| 2012 | Year | 01 | Month | 12 | Day |
Last modified on
| 2021 | Year | 07 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008316
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
