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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000031513
Receipt No. 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 2018/06/07

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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
Middle name
Last name Naoto Tamura
Organization Juntendo university school of medicine
Division name Department of internal medicine and rheumatology
Zip code
Address 2-1-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL 0338133111
Email yo-abe@juntendo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshiyuki Abe
Organization Juntendo University School of Medicine
Division name Department of Internal Medicine and Rheumatology
Zip code
Address 2-1-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL 0338133111
Homepage URL
Email yo-abe@juntendo.ac.jp

Sponsor
Institute Juntendo University School of Medicin
Institute
Department

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
Address
Tel
Email

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
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 Open public recruiting
Date of protocol fixation
2018 Year 02 Month 28 Day
Date of IRB
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
2018 Year 06 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035982

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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