UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047294 |
|---|---|
| Receipt number | R000053937 |
| Scientific Title | A study of a patient with non-HIV pneumocystis pneumonia who required admission to the intensive care unit for treatment |
| Date of disclosure of the study information | 2022/03/26 |
| Last modified on | 2022/03/26 20:52:37 |
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Basic information
Public title
A study of a patient with non-HIV pneumocystis pneumonia who required admission to the intensive care unit for treatment
Acronym
A study of a patient with non-HIV pneumocystis pneumonia who required admission to the intensive care unit for treatment
Scientific Title
A study of a patient with non-HIV pneumocystis pneumonia who required admission to the intensive care unit for treatment
Scientific Title:Acronym
A study of a patient with non-HIV pneumocystis pneumonia who required admission to the intensive care unit for treatment
Region
| Japan |
Condition
Condition
non-HIV pneumocystis pneumonia
Classification by specialty
| Pneumology | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the disease background, ventilatory status, and prognosis of non HIV-PCP patients who required admission and treatment in our intensive care unit
Basic objectives2
Others
Basic objectives -Others
To determine the disease background, ventilatory status, and prognosis of non HIV-PCP patients who required admission and treatment in our intensive care unit
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
90-day mortality
Key secondary outcomes
Disease Background
Ventilated or not ventilated
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
PCP is suspected by various tests at the time of ICU admission.
Key exclusion criteria
Patients deemed unsuitable as subjects by the principal investigator
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Nomura |
Organization
Tokyo Women's Medical University
Division name
Department of Intensive Care Medicine
Zip code
162-8666
Address
8-1, Kawada-cho, Shinjuku-ku, Tokyo
TEL
03-3353-8111
tnomura@twmu.ac.jp
Public contact
Name of contact person
| 1st name | Nobuo |
| Middle name | |
| Last name | Sato |
Organization
Tokyo Women's Medical University
Division name
Department of Intensive Care Medicine
Zip code
162-8666
Address
8-1, Kawada-cho, Shinjuku-ku, Tokyo
TEL
03-3353-8111
Homepage URL
sato.nobuo@twmu.ac.jp
Sponsor or person
Institute
Tokyo Women's Medical University
Institute
Department
Personal name
Funding Source
Organization
self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Women's Medical University Ethics Review Board
Address
8-1, Kawada-cho, Shinjuku-ku, Tokyo
Tel
03-3353-8111
rinri.bm@twmu.ac.jp
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
| 2022 | Year | 03 | Month | 26 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
12
Results
There were 12 eligible patients during the study period. All of them had diffuse bilateral ground-glass opacity on chest CT upon admission to the ICU, and their blood Beta-D glucan levels were also high. The diagnosis was confirmed by sputum fluorescent antibody or PCR. The median stay in the ICU was 7.5 days, and 6 patients required intubation for ventilation, 2 of whom underwent tracheostomy. 90 days after ICU admission, 10 patients were alive and 2 died.
Results date posted
| 2022 | Year | 03 | Month | 26 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2019 | Year | 08 | Month | 04 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 04 | Month | 26 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 31 | Day |
Anticipated trial start date
| 2019 | Year | 05 | Month | 31 | Day |
Last follow-up date
| 2022 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The project was completed without trouble.
Management information
Registered date
| 2022 | Year | 03 | Month | 26 | Day |
Last modified on
| 2022 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053937
