UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043849 |
|---|---|
| Receipt number | R000049585 |
| Scientific Title | The validation study of the value of serum procalcitonin for predicting the prognosis of patients with pulmonary tuberculosis. |
| Date of disclosure of the study information | 2021/04/06 |
| Last modified on | 2024/04/09 10:13:05 |
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Basic information
Public title
The validation study of the value of serum procalcitonin for predicting the prognosis of patients with pulmonary tuberculosis.
Acronym
The validation study of the value of serum procalcitonin for predicting the prognosis of patients with pulmonary tuberculosis.
Scientific Title
The validation study of the value of serum procalcitonin for predicting the prognosis of patients with pulmonary tuberculosis.
Scientific Title:Acronym
The validation study of the value of serum procalcitonin for predicting the prognosis of patients with pulmonary tuberculosis.
Region
| Japan |
Condition
Condition
Pulmonary tuberculosis
Classification by specialty
| Medicine in general | Pneumology | Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study is validating the prognostic value of serum procalcitonin in pulmonary tuberculosis, which has been shown in a preceding study (J Infect Dis. 2020 May 23:jiaa275. doi: 10.1093/infdis/jiaa275).
Basic objectives2
Others
Basic objectives -Others
Predicting the prognosis
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
In-hospital mortality
Key secondary outcomes
Length of hospital stay
Duration of sputum culture conversion of acid fast bacilli
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Newly diagnosed active pulmonary tuberculosis, with or without extrapulmonary tuberculosis; and no treatment with antituberculosis agents on admission.
Key exclusion criteria
Disseminated tuberculosis (ie, positive M. tuberculosis PCR or culture test results for urine, blood, or cerebrospinal fluid) or a history of tuberculosis treatment in the 10 years before recruitment.
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Osawa |
Organization
Japan Anti-Tuberculosis Association (JATA), Fukujuji Hospital
Division name
Department of Respiratory Medicine
Zip code
2040022
Address
3-1-24 Matsuyama, Kiyose-shi, Tokyo 204-8522, Japan
TEL
0424914111
take4.osawa@nifty.com
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Osawa |
Organization
Japan Anti-Tuberculosis Association (JATA), Fukujuji Hospital
Division name
Department of Respiratory Medicine
Zip code
2040022
Address
3-1-24 Matsuyama, Kiyose-shi, Tokyo 204-8522, Japan
TEL
0424914111
Homepage URL
take4.osawa@nifty.com
Sponsor or person
Institute
Japan Anti-Tuberculosis Association (JATA), Fukujuji Hospital
Institute
Department
Personal name
Funding Source
Organization
There is no funding source.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
FUJIFILM Wako Pure Chemical Corporation
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Japan Anti-Tuberculosis Association (JATA), Fukujuji Hospital
Address
3-1-24 Matsuyama, Kiyose-shi, Tokyo 204-8522, Japan
Tel
0424914111
shom@fukujuji.org
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
| 2021 | Year | 04 | Month | 06 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/37726072/
Publication of results
Partially published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/37726072/
Number of participants that the trial has enrolled
165
Results
The data from 252 patients in the development cohort and 165 patients in the validation cohort were analyzed, of whom 39 (15.5%) and 17 (10.3%), respectively, died in
the hospital. The disease severity score (named the AHL score) included three clinical parameters: activities of daily living (semi-dependent, 1 point; totally dependent, 2 points);
hypoxemia (1 point), and lymphocytes (< 720/mL, 1 point).
Results date posted
| 2024 | Year | 04 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
None of these patients was co-infected with HIV. Patient characteristics were similar in both cohorts, except that more patients in the validation cohort had cavitary lesions, extrapulmonary lesions, and were smear-positive for sputum AFB. Among the patients in the development cohort, 39 patients (15.5%) died in the hospital, and 213 patients (84.5%) survived following treatment (Table 2). Among the patients in the validation cohort, 17 (10.3%) died in the hospital, and 148 (89.7%) survived following treatment.
Participant flow
A total of 406 and 290 patients were eligible according to the inclusion criteria in the development cohort and validation cohort, respectively. After the exclusion criteria were applied, the data from 252 and 165 patients who gave written informed consent were analyzed.
Adverse events
Not applicable
Outcome measures
All-cause in-hospital mortality
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2020 | Year | 09 | Month | 02 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 12 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The primary endpoint is patients death in hospital.
The study participants will be observed until leaving hospital.
Management information
Registered date
| 2021 | Year | 04 | Month | 06 | Day |
Last modified on
| 2024 | Year | 04 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049585
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