UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060898 |
|---|---|
| Receipt number | R000069690 |
| Scientific Title | A prospective, randomised non-inferiority trial evaluating the efficacy and safety of low-dose Sulfamethoxazole-Trimethoprim prophylaxis for Pneumocystis pneumonia in patients with interstitial lung disease |
| Date of disclosure of the study information | 2026/03/11 |
| Last modified on | 2026/03/11 16:05:45 |
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Basic information
Public title
Prospective study evaluating the efficacy and safety of low-dose trimethoprim-sulfamethoxazole for prevention of Pneumocystis pneumonia in patients with interstitial lung disease
Acronym
STILD Study
Scientific Title
A prospective, randomised non-inferiority trial evaluating the efficacy and safety of low-dose Sulfamethoxazole-Trimethoprim prophylaxis for Pneumocystis pneumonia in patients with interstitial lung disease
Scientific Title:Acronym
STILD Study
Region
| Japan |
Condition
Condition
Interstitial Lung Disease
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to evaluate the efficacy and safety of low-dose sulfamethoxazole-trimethoprim prophylaxis for the prevention of Pneumocystis pneumonia (PCP) in patients with interstitial lung disease. This prospective randomized trial aims to determine whether low-dose ST prophylaxis is non-inferior to the conventional prophylactic regimen in preventing PCP.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Incidence of treatment discontinuation due to adverse events and incidence of severe adverse events (Grade 3 or higher according to CTCAE v5.0)
Key secondary outcomes
Incidence rate of Pneumocystis jirovecii pneumonia (PCP)
Time to treatment discontinuation or occurrence of severe adverse events (Grade 3 or higher)
Incidence of subclinical PCP and subsequent management
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
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
In the standard-dose group, one tablet of sulfamethoxazole-trimethoprim (sulfamethoxazole 400 mg / trimethoprim 80 mg) is administered orally once daily. Treatment is continued during corticosteroid therapy for up to 48 weeks.
Interventions/Control_2
In the intervention group, one tablet of sulfamethoxazole-trimethoprim (400 mg/80 mg) is administered three times per week (e.g., Monday, Wednesday, and Friday). Treatment is continued during corticosteroid therapy for up to 48 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
Patients aged 20 years or older with interstitial lung disease receiving corticosteroid therapy.
Key exclusion criteria
Patients with HIV infection, a history of organ transplantation, or those who are pregnant or breastfeeding, as well as patients planning pregnancy during the study period. Patients with severe renal impairment (eGFR < 30 mL/min/1.73 m2) will be assigned to the renal impairment group.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Yusuke |
| Middle name | |
| Last name | Tanaka |
Organization
Sapporo Medical University
Division name
Department of Respiratory Medicine and Allergology
Zip code
060-8543
Address
S1 W16, Chuo-ku, Sapporo, Hokkaido
TEL
011-611-2111
tanayou@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | Yusuuke |
| Middle name | |
| Last name | Tanaka |
Organization
Sapporo Medical University
Division name
Department of Respiratory Medicine and Allergology
Zip code
060-8543
Address
S1 W16, Chuo-ku, Sapporo, Hokkaido
TEL
011-611-2111
Homepage URL
tanayou@sapmed.ac.jp
Sponsor or person
Institute
Sapporo Medical University
Institute
Department
Personal name
Funding Source
Organization
Sapporo Medical University
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
Sapporo Medical University
Address
S1 W16, Chuo-ku, Sapporo, Hokkaido
Tel
011-611-2111
ji-rskk@sapmed.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
| 2026 | Year | 03 | Month | 11 | 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
| 2025 | Year | 06 | Month | 12 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 12 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 03 | Month | 11 | Day |
Last modified on
| 2026 | Year | 03 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069690
