UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062449 |
|---|---|
| Receipt number | R000071474 |
| Scientific Title | Initial Antibiotic Prescribing for Uncomplicated Acute Respiratory Tract Infection and 14-Day Pneumonia or Respiratory Hospitalization: A Target Trial Emulation Using a Large Japanese Claims Database |
| Date of disclosure of the study information | 2026/08/03 |
| Last modified on | 2026/08/03 15:43:10 |
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Basic information
Public title
A study of whether prescribing an antibiotic at the first outpatient visit for common uncomplicated acute respiratory tract infection (common cold, acute upper respiratory infection, or acute bronchitis) reduces pneumonia or respiratory-infection-related hospitalization within 14 days, using a large health insurance claims database
Acronym
Antibiotics-ARTI Study (JMDC)
Scientific Title
Initial Antibiotic Prescribing for Uncomplicated Acute Respiratory Tract Infection and 14-Day Pneumonia or Respiratory Hospitalization: A Target Trial Emulation Using a Large Japanese Claims Database
Scientific Title:Acronym
Antibiotics-ARTI TTE Study (JMDC)
Region
| Japan |
Condition
Condition
Uncomplicated acute respiratory tract infection (common cold, acute upper respiratory infection, or acute bronchitis); the outcome is pneumonia or respiratory-infection-related hospitalization.
Classification by specialty
| Pneumology | Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Using the JMDC Claims Database, to estimate whether prescribing a systemic antibiotic (WHO-ATC J01) at the index outpatient visit (time zero) for common cold, acute upper respiratory infection, or acute bronchitis, compared with no prescription, is associated with the 14-day risk of pneumonia or respiratory-infection-related hospitalization, within a target trial emulation framework. The average treatment effect in the overlap population (risk ratio and risk difference) is estimated using propensity-score overlap weighting.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
A composite of pneumonia (ICD-10 J12-J18) or respiratory-infection-related hospitalization within 14 days after time zero (the index outpatient visit). Risk ratios and risk differences (95% CI, facility-cluster-robust variance) are estimated in the propensity-score overlap-weighted population using 29 patient-level covariates.
Key secondary outcomes
Secondary and more specific outcomes: any pneumonia diagnosis, respiratory hospitalization, pneumonia hospitalization, bacterial pneumonia (J13-J16), and respiratory hospitalization with the respiratory diagnosis recorded as principal or admission-precipitating. Pre-specified analyses: interval-specific (days 1-2, 3-7, 8-14) and landmark (day 2/3/5/7) analyses, a facility prescribing-preference sensitivity analysis, an oral-only uncomplicated cohort, diagnosis-group strata (J00/J06/J20), negative-control outcomes (injury, back pain, non-respiratory hospitalization), E-values, and a development/validation split.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
First-per-patient outpatient episodes of common cold (ICD-10 J00), acute upper respiratory infection (J06.x), or acute bronchitis (J20.x) in the JMDC Claims Database (employment-based and late-elderly enrollees; data observation period 2005-2025; suspected diagnoses excluded). Eligibility requires at least 6 months of prior enrollment, no qualifying respiratory diagnosis, systemic antibiotic, or severe respiratory outcome in the preceding 30 days (antibiotic/respiratory washout), and no pneumonia, other same-day antibiotic-indication infection, or respiratory hospitalization on or within 3 days around time zero. One first episode per person is analysed. All ages.
Key exclusion criteria
Episodes with suspected diagnoses. Less than 6 months of continuous enrollment before time zero. A qualifying respiratory diagnosis, systemic antibiotic, or severe respiratory outcome within the 30 days before time zero. Pneumonia, another same-day antibiotic-indication infection, or respiratory hospitalization on or within 3 days around time zero.
Target sample size
12233602
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Kutsuna |
Organization
The University of Osaka, Graduate School of Medicine Faculty of Medicine
Division name
Department of Infection Prevention and Control
Zip code
565-0871
Address
2-2, Yamadaoka, Suita city
TEL
0836-6879-5111
kutsuna@hp-infect.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Kutsuna |
Organization
The University of Osaka, Graduate School of Medicine Faculty of Medicine
Division name
Department of Infection Prevention and Control
Zip code
565-0871
Address
2-2, Yamadaoka, Suita city
TEL
0836-6879-5111
Homepage URL
kutsuna@hp-infect.med.osaka-u.ac.jp
Sponsor or person
Institute
The University of Osaka, Graduate School of Medicine Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
The University of Osaka
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
The University of Osaka Hospital, Ethical Review Board
Address
2-15, Yamadaoka, Suita city
Tel
0836-6879-5111
rinri@hp-crc.med.osaka-u.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
大阪大学大学院医学系研究科 感染制御学 / The University of Osaka, Graduate School of Medicine
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 08 | Month | 03 | 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
12233602
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
| 2026 | Year | 04 | Month | 14 | Day |
Date of IRB
| 2026 | Year | 04 | Month | 14 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 14 | Day |
Last follow-up date
| 2026 | Year | 08 | Month | 03 | Day |
Date of closure to data entry
| 2026 | Year | 08 | Month | 03 | Day |
Date trial data considered complete
| 2026 | Year | 08 | Month | 03 | Day |
Date analysis concluded
| 2026 | Year | 08 | Month | 03 | Day |
Other
Other related information
This is a retrospective target trial emulation using the JMDC Claims Database (employment-based and late-elderly databases; data observation period 2005 to 2025). Prescribing versus not prescribing a systemic antibiotic at the first outpatient visit for common cold, acute upper respiratory infection, or acute bronchitis was compared, and the average treatment effect on 14-day pneumonia or respiratory hospitalization was estimated in the propensity-score overlap-weighted population. Existing anonymized data were analysed after institutional review board approval.
Management information
Registered date
| 2026 | Year | 08 | Month | 03 | Day |
Last modified on
| 2026 | Year | 08 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071474
