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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000043849
Receipt No. 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 2021/04/06

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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
Email 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
Email take4.osawa@nifty.com

Sponsor
Institute Japan Anti-Tuberculosis Association (JATA), Fukujuji Hospital
Institute
Department

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
Email 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
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
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
2021 Year 04 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049585

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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