TuberculosisNCT06284187
Diagnosis Test of Real-time Polymerase Chain Reaction (RT-PCR) for Pulmonary Tuberculosis
An observational study of Tuberculosis and Pulmonary, run by Khon Kaen Hospital at 1 site in Thailand.
Trial summary
BACKGROUND: Pulmonary tuberculosis remains the leading cause of morbidity and mortality in Thailand. The microbiological detection of TB is important because of early and correct diagnosis, drug resistance testing and ensures that the effective treatment can be achieved and in a timely manner. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Tuberculosis, Pulmonary
- How many people
- 120 participants
- Where
- 1 siteThailand
- Study dates
- 1 Jan 2023to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- Child, Adult, Older adult
Study population: out patients clinic
Who may be able to join
- Clinical suspected pulmonary M. tuberculosis infection
- Aged 15 years and older
Who cannot join
- Children under 15 years old
- Non-tuberculous mycobacteria (NTM) detection
Trial locations and contacts
1 site in 1 country.
About this study
BACKGROUND: Pulmonary tuberculosis remains the leading cause of morbidity and mortality in Thailand. The microbiological detection of TB is important because of early and correct diagnosis, drug resistance testing and ensures that the effective treatment can be achieved and in a timely manner. Mycobacterial culture is the gold standard diagnostic test. Currently, a real-time polymerase chain reaction (RT-PCR) assay, such as Allplex™ MTB/MDRe Detection, Seegene is commonly used.
OBJECTIVE: To evaluate the diagnosis value of the real-time multiplex PCR by using Allplex™ MTB/MDRe Detection kit to detect MTB from sputum specimens with a gold standard TB culture.
Read the detailed description
A retrospective study design of adult patients (\> 15 years) with suspected pulmonary M. tuberculosis infection was conducted from January 2023 until October 2023, at Khon Kaen Hospital. Sample size was 101 cases. Sensitivity, specificity, accuracy, negative predictive value (NPV), and positive predictive value (PPV) of Allplex™ MTB/MDRe Detection, each with its respective 95% confidence interval (95% CI) were analysed with compared to MTB culture as the gold standard.
- Conditions
- Tuberculosis, Pulmonary
- Keywords
- pulmonary tuberculosis, real-time PCR, diagnosis test
- Medical subject headings
- Tuberculosis, Tuberculosis, Pulmonary
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with pulmonary TB by Allplex™ MTB/MDRe
Laboratory parameter
Measured: From enrollment to the end of diagnosis at 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start1 Jan 2023
- Primary completion31 Oct 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Khon Kaen Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Kriengsak Vacharanukulkieti, Khon Kaen Hospital
- Investigators
- Kriengsak Vacharanukulkieti, Medicine, Principal investigator, Khon Kaen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06284187
- Sponsor's protocol ID
- KhonKaenH
- Status last verified
- Feb 2024
- First submitted
- 19 Feb 2024
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosis Test of Real-time Polymerase Chain Reaction (RT-PCR) for Pulmonary Tuberculosis
- ClinicalTrials.gov ID
- NCT06284187
- Acronym / sponsor ID
- KhonKaenH
- Conditions
- Tuberculosis, Pulmonary
- Keywords
- pulmonary tuberculosis, real-time PCR, diagnosis test
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Khon Kaen HospitalOther government
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 28 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
BACKGROUND: Pulmonary tuberculosis remains the leading cause of morbidity and mortality in Thailand. The microbiological detection of TB is important because of early and correct diagnosis, drug resistance testing and ensures that the effective treatment can be achieved and in a timely manner. Mycobacterial culture is the gold standard diagnostic test. Currently, a real-time polymerase chain reaction (RT-PCR) assay, such as Allplex™ MTB/MDRe Detection, Seegene is commonly used.
OBJECTIVE: To evaluate the diagnosis value of the real-time multiplex PCR by using Allplex™ MTB/MDRe Detection kit to detect MTB from sputum specimens with a gold standard TB culture.
Detailed description
A retrospective study design of adult patients (\> 15 years) with suspected pulmonary M. tuberculosis infection was conducted from January 2023 until October 2023, at Khon Kaen Hospital. Sample size was 101 cases. Sensitivity, specificity, accuracy, negative predictive value (NPV), and positive predictive value (PPV) of Allplex™ MTB/MDRe Detection, each with its respective 95% confidence interval (95% CI) were analysed with compared to MTB culture as the gold standard.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- out patients clinic
Key inclusion criteria (2 listed)
- Clinical suspected pulmonary M. tuberculosis infection
- Aged 15 years and older
Key exclusion criteria (2 listed)
- Children under 15 years old
- Non-tuberculous mycobacteria (NTM) detection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of participants with pulmonary TB by Allplex™ MTB/MDRe
Time frame: From enrollment to the end of diagnosis at 1 week
Laboratory parameter
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kriengsak Vacharanukulkieti, Medicine principal investigator
Khon Kaen Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tuberculosis and Pulmonary, run by Khon Kaen Hospital at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with pulmonary TB by Allplex™ MTB/MDRe (time frame: From enrollment to the end of diagnosis at 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.