UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000063082 |
|---|---|
| Receipt number | R000072184 |
| Scientific Title | Impact of Treatment Changes Due to Erythromycin Supply Interruption on Exacerbations in Patients with Non-Cystic Fibrosis Bronchiectasis: A Multicenter Retrospective Cohort Study |
| Date of disclosure of the study information | 2026/09/28 |
| Last modified on | 2026/09/28 19:02:52 |
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Basic information
Public title
Impact of erythromycin supply interruption on patients with bronchiectasis
Acronym
Erythromycin Supply Interruption and Bronchiectasis
Scientific Title
Impact of Treatment Changes Due to Erythromycin Supply Interruption on Exacerbations in Patients with Non-Cystic Fibrosis Bronchiectasis: A Multicenter Retrospective Cohort Study
Scientific Title:Acronym
Erythromycin Supply Interruption and Bronchiectasis Study
Region
| Japan |
Condition
Condition
Non-cystic fibrosis bronchiectasis
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the impact of discontinuation of erythromycin or switching to another macrolide due to erythromycin supply interruption on bronchiectasis exacerbations in patients with non-cystic fibrosis bronchiectasis who had received erythromycin for at least 12 months.
Basic objectives2
Others
Basic objectives -Others
To explore the clinical characteristics associated with bronchiectasis exacerbations after discontinuation of erythromycin and the patient characteristics associated with switching from erythromycin to another macrolide.
Furthermore, in patients who switched from erythromycin to clarithromycin, the number of bronchiectasis exacerbations before and after the switch will be compared to explore the potential clinical effectiveness of long-term low-dose clarithromycin therapy.
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Number of bronchiectasis exacerbations during the 12 months before and after treatment modification in patients who had received erythromycin for at least 12 months, comparing those who discontinued erythromycin with those who switched to another macrolide.
Key secondary outcomes
1.Time to the first bronchiectasis exacerbation within 12 months before and after treatment modification among patients who had received erythromycin for at least 12 months, comparing the erythromycin discontinuation group with the group switched to another macrolide
2.Number of bronchiectasis exacerbations during the 12 months before and after treatment modification, comparing the erythromycin discontinuation group with the group switched to clarithromycin
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Age 20 years or older.
2.Diagnosis of non-cystic fibrosis bronchiectasis.
3.Treatment with erythromycin for at least 3 months.
4.Discontinuation of erythromycin or switching to another macrolide due to erythromycin supply interruption between July 2024 and August 2025.
Key exclusion criteria
1.Patients who discontinued or changed erythromycin for reasons other than erythromycin supply interruption.
2.Patients receiving long-term antimicrobial therapy for an indication other than bronchiectasis.
3.Patients with less than 3 months of follow-up after erythromycin discontinuation or switching.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Saiki |
| Middle name | |
| Last name | Yoshimura |
Organization
National Hospital Organization Kyoto Medical Center
Division name
Division of Respiratory Medicine, Center for Respiratory Diseases
Zip code
6128555
Address
1-1 Fukakusa-Mukaihata-Cho, Fushimi-Ku, Kyoto, Japan.
TEL
0756419161
syoshimura.kmc@gmail.com
Public contact
Name of contact person
| 1st name | Saiki |
| Middle name | |
| Last name | Yoshimura |
Organization
National Hospital Organization Kyoto Medical Center
Division name
Division of Respiratory Medicine, Center for Respiratory Diseases
Zip code
6128555
Address
1-1 Fukakusa-Mukaihata-Cho, Fushimi-Ku, Kyoto, Japan.
TEL
0756419161
Homepage URL
syoshimura.kmc@gmail.com
Sponsor or person
Institute
National Hospital Organization Kyoto Medical Center
Institute
Department
Personal name
Funding Source
Organization
other
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Hospital Organization Kyoto Medical Center
Address
1-1 Fukakusa-Mukaihata-Cho, Fushimi-Ku, Kyoto, Japan.
Tel
0756419161
404-rinri@mail.hosp.go.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 | 09 | Month | 28 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 09 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 09 | Month | 15 | Day |
Last follow-up date
| 2028 | Year | 09 | Month | 14 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2026 | Year | 09 | Month | 28 | Day |
Last modified on
| 2026 | Year | 09 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072184
