UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048368 |
|---|---|
| Receipt number | R000055129 |
| Scientific Title | Study on detection of sputum smear-positive and culture negative status during pulmonary tuberculosis treatment |
| Date of disclosure of the study information | 2022/07/15 |
| Last modified on | 2024/07/17 17:44:20 |
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Basic information
Public title
Study on detection of sputum smear-positive and culture negative status during pulmonary tuberculosis treatment
Acronym
Study on detection of sputum smear-positive and culture negative status during pulmonary tuberculosis treatment
Scientific Title
Study on detection of sputum smear-positive and culture negative status during pulmonary tuberculosis treatment
Scientific Title:Acronym
Study on detection of sputum smear-positive and culture negative status during pulmonary tuberculosis treatment
Region
| Japan |
Condition
Condition
Sputum smear positive pulmonary tuberculosis
Classification by specialty
| Pneumology | Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify risk factors for smear-positive and culture-negative status and their duration during treatment of patients with pulmonary tuberculosis.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Risk factors of smear positive and culture negative status
Key secondary outcomes
Duration of smear positive and culture negative status
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
(1) The patients with pulmonary tuberculosis patients admitted and treated at National Hospital Organization Wakayama Hospital from April 2018 to March 2021
(2) Patients who had a positive sputum smear test at the start of treatment
(3) Patients who met discharge criteria (three consecutive negative sputum smears or three consecutive negative sputum cultures) during hospitalization
Key exclusion criteria
(1) Patients with sputum smear-negative tuberculosis
(2) Patients with death, discharge, or transfer without meeting discharge criteria
Target sample size
122
Research contact person
Name of lead principal investigator
| 1st name | Masanori |
| Middle name | |
| Last name | Tanaka |
Organization
National Hospital Organization Wakayama Hospital
Division name
Department of Respiratory Medicine
Zip code
644-0044
Address
1138, Ooziada, Mihama, Hidaka, Wakayama, Japan
TEL
0738223256
msnrmsnr@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Masanori |
| Middle name | |
| Last name | Tanaka |
Organization
National Hospital Organization Wakayama Hospital
Division name
Department of Respiratory Medicine
Zip code
641-8510
Address
1138, Ooziada, Mihama, Hidaka, Wakayama, Japan
TEL
0738223256
Homepage URL
msnrmsnr@wakayama-med.ac.jp
Sponsor or person
Institute
National Hospital Organization Wakayama Hospital
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
National Hospital Organization Wakayama Hospital
Address
1138, Ooziada, Mihama, Hidaka, Wakayama, Japan
Tel
0738223256
419-kenkyubu@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
| 2022 | Year | 07 | Month | 15 | 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
Completed
Date of protocol fixation
| 2022 | Year | 03 | Month | 22 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 23 | Day |
Anticipated trial start date
| 2022 | Year | 03 | Month | 24 | Day |
Last follow-up date
| 2022 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2022 | Year | 07 | Month | 13 | Day |
Last modified on
| 2024 | Year | 07 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055129
