UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031513 |
|---|---|
| Receipt number | R000035982 |
| Scientific Title | Optimal regimens of sulfamethoxazole-trimethoprim for prophylaxis of pneumocystis pneumonia in patients with systemic rheumatic diseases: multi-center randomized open label trial |
| Date of disclosure of the study information | 2018/03/01 |
| Last modified on | 2022/09/06 12:56:29 |
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Basic information
Public title
Optimal regimens of sulfamethoxazole-trimethoprim for prophylaxis of pneumocystis pneumonia in patients with systemic rheumatic diseases: multi-center randomized open label trial
Acronym
Optimal regimens of Baktar for prophylaxis of pneumocystis pneumonia in patients with systemic rheumatic diseases
Scientific Title
Optimal regimens of sulfamethoxazole-trimethoprim for prophylaxis of pneumocystis pneumonia in patients with systemic rheumatic diseases: multi-center randomized open label trial
Scientific Title:Acronym
Optimal regimens of Baktar for prophylaxis of pneumocystis pneumonia in patients with systemic rheumatic diseases
Region
| Japan |
Condition
Condition
Pneumocystis pneumonia
Classification by specialty
| Medicine in general | Clinical immunology | Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We designed to show the non-inferiority of the half-dose prophylaxis group by comparing the two groups of conventional therapy group (SMX/TMP of 400/80 mg daily) and half-dose prevention group (SMX/TMP of 200/40 mg daily).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary endpoint was non-incidence rate of PCP at week 52.
Key secondary outcomes
The secondary endpoint was drug continuation rate at week 52.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
YES
Dynamic allocation
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
SMX/TMP of daily 400 mg/80 mg for 52 weeks.
Interventions/Control_2
SMX/TMP of daily 200 mg/40 mg for 52 weeks.
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
1. Men and women aged over 20 years
2. Being admitted to our hospitals for diagnosis and/or treatment of new-onset or relapsed systemic rheumatic diseases from 1st April 2018 to 31st March 2021.
3. Have received 0.6 mg/kg/day or more of oral prednisolone or equivalent doses of corticosteroids with or without any immunosuppressant
4. Have not used SMX/TMP, pentamidine isethionate, dapsone, or atovaquone previously
5. Have serum creatinine level within the normal range of the institution.
6. Able and willing to give written informed consent
Key exclusion criteria
1. Have contraindications to SMX/TMP
2. Have a history of PCP
3. Have received biologic agents
4. Have uncontrollable complications
5. Body weight below 40 kg
6. Being pregnant or a nursing woman
7. Being unable to start SMX/TMP within 14 days of starting prednisolone
8. Unable to give informed consent
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Naoto |
| Middle name | |
| Last name | Tamura |
Organization
Juntendo university school of medicine
Division name
Department of internal medicine and rheumatology
Zip code
1130033
Address
2-1-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL
0338133111
yo-abe@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Yoshiyuki |
| Middle name | |
| Last name | Abe |
Organization
Juntendo University School of Medicine
Division name
Department of Internal Medicine and Rheumatology
Zip code
1130033
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
0338133111
Homepage URL
yo-abe@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University School of Medicin
Institute
Department
Personal name
Funding Source
Organization
None
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
Juntendo University
Address
2-1-1, Hongo, Bunkyo-Ku, Tokyo
Tel
0338133111
kenkyu5858@juntendo.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
順天堂大学医学部附属順天堂醫院(東京)、順天堂東京江東高齢者医療センター(東京)
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 03 | Month | 01 | 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
89
Results
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
| 2018 | Year | 02 | Month | 28 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 23 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 02 | Month | 28 | Day |
Last modified on
| 2022 | Year | 09 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035982
