UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046230 |
|---|---|
| Receipt number | R000052760 |
| Scientific Title | Clinical features of PCP in non-HIV infected patients: A systemic review and meta-analysis |
| Date of disclosure of the study information | 2021/11/30 |
| Last modified on | 2024/10/25 15:27:08 |
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Basic information
Public title
Clinical features of PCP in non-HIV infected patients: A systemic review and meta-analysis
Acronym
Clinical features of PCP in non-HIV infected patients: A systemic review and meta-analysis
Scientific Title
Clinical features of PCP in non-HIV infected patients: A systemic review and meta-analysis
Scientific Title:Acronym
Clinical features of PCP in non-HIV infected patients: A systemic review and meta-analysis
Region
| Japan | Asia(except Japan) | North America |
| South America | Australia | Europe |
| Africa |
Condition
Condition
Pneumocystis pneumounia
Classification by specialty
| Medicine in general | Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify the clinical feature of pneumocystis pneumounia in non-HIV patients
Basic objectives2
Others
Basic objectives -Others
Radiographic findings
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
clinical features
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Pneumocystis pneumonia in non-HIV adults
Key exclusion criteria
PCP in children
Target sample size
10000
Research contact person
Name of lead principal investigator
| 1st name | Hao |
| Middle name | |
| Last name | Chen |
Organization
Teikyo University Hospital
Division name
Department of Oncology
Zip code
173-8606
Address
2-11-1 Kaga, Itahashi, Tokyo
TEL
03-3964-1211
chinsmd@gmail.com
Public contact
Name of contact person
| 1st name | Hao |
| Middle name | |
| Last name | Chen |
Organization
Teikyo University Hospital
Division name
Department of Oncology
Zip code
173-8606
Address
2-11-1 Kaga, Itahashi, Tokyo
TEL
03-3964-1211
Homepage URL
chinsmd@gmail.com
Sponsor or person
Institute
Teikyo University Hospital
Department of Oncology
Institute
Department
Personal name
Funding Source
Organization
Teikyo University Hospital
Department of Oncology
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
Teikyo University Hospital Department of Oncology
Address
2-11-1 Kaga, Itahashi, Tokyo
Tel
03-3964-1211
chinsmd@gmail.com
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
| 2021 | Year | 11 | Month | 30 | Day |
Related information
URL releasing protocol
https://jclinque.com/article/clinical-features-of-pneumocystis-pneumonia-in-non-human-immunodeficien
Publication of results
Unpublished
Result
URL related to results and publications
https://jclinque.com/article/clinical-features-of-pneumocystis-pneumonia-in-non-human-immunodeficien
Number of participants that the trial has enrolled
10133
Results
Viral, bacterial, and fungal co-infection were observed in 28% (95% CI: 13, 44), 19% (95% CI: 13, 25), and 11% (95% CI: 6, 16) of patients, respectively. Laboratory data showed a trend of elevated WBC, LDH, CRP, beta-D glucan, and KL-6. Ground glass opacity (GGO) was found in 87% (95% CI: 83, 91) of patients. In-hospital mortality was 41% (95% CI: 35, 46).
Results date posted
| 2024 | Year | 10 | Month | 25 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
65 articles that included 10,133 PCP patients without HIV infection were enrolled. PCP occurred most commonly at age 59.2 years (95% CI: 57.7, 60.7) in a gender ratio of approximately 3 to 2 (males to females). Dyspnea, fever, cough, and sputum were nonspecific clinical findings in 73% (95% CI: 69, 79), 73% (95% CI: 65, 81), 56% (95% CI: 48%, 64%), and 32% (96%CI: 16, 48) of patients, respectively.
Participant flow
Not availabe
Adverse events
Not availabe
Outcome measures
Not availabe
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 11 | Month | 30 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 30 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 30 | Day |
Last follow-up date
| 2022 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2021 | Year | 11 | Month | 30 | Day |
Last modified on
| 2024 | Year | 10 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052760
