Latent TuberculosisNCT04552015
Microneedles for Diagnosis of LTBI
A study testing TST vs PPD microneedle test in people with Latent Tuberculosis, run by The HIV Netherlands Australia Thailand Research Collaboration at 1 site in Thailand.
Trial summary
This study will evaluate new technique, microneedle, to detect latent tuberculosis (TB) in healthy volunteers Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Latent Tuberculosis
- What is being tested?
- TST vs PPD microneedle test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteThailand
- Study dates
- 8 Apr 2021to 1 Oct 2022
- Phase
- Interventional
- 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Sex : Male and Female
- Age : 20-60 years
- TB contacts or those at risk of TB e.g. health-care workers
- HIV-negative healthy individuals
Who cannot join
- Presence of an acute infection, as determined by investigators
- Receiving immunosuppression drugs e.g. steroids
- Having autoimmune diseases e.g. SLE (Systemic Lupus Erythematous)
- Being pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study for Development of Microneedles for Diagnosis of Latent Tuberculosis Infection
This study will evaluate new technique, microneedle, to detect latent tuberculosis (TB) in healthy volunteers
Read the detailed description
The cross-sectional study to investigate the effect of microneedle formulations and lengths of Tuberculin PPD microneedles on the delayed-type hypersensitivity response in healthy volunteers.
- Conditions
- Latent Tuberculosis
- Being tested
- TST vs PPD microneedle test
- Medical subject headings
- Latent Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TST vs PPD microneedle testDiagnostic test
TST vs First patch: 800 um in length, PPD1 formulation; Second patch: 1,500 um in length, PPD1 formulation; Third patch: 800 um in length, PPD2 formulation; and Fourth patch: 1,500 um in length, PPD2 formulation
| Study group | Role | What they receive |
|---|---|---|
| volunteers | Other | two different types of diagnostic tools (TST vs microneedle) will be used to screen for latent TB infection Receives: Diagnostic Test: TST vs PPD microneedle test |
What is being measured
The primary outcome is the main question the study is designed to answer.
size of induration at 48 hours post-PPD injection
Monitoring the response of delayed-type hypersensitivity on the skin by comparing TST to microneedle tests
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2020
- Study start8 Apr 2021
- Primary completion1 Oct 2022
- Study completion1 Oct 2022
Why it stopped: There is a problem with the investigational product
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Latent 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- The HIV Netherlands Australia Thailand Research Collaboration
- Sponsor type
- University, hospital or other
- Collaborators
- National Nanotechnology Center (NANOTEC), The National Science and Technology Development Agency (NSTDA)
- Responsible party
- Sponsor
- Investigators
- Sivaporn Gatechompol, MD, Principal investigator, The HIV Netherlands Australia Thailand Research CollaborationJeerapond Leelawattanachai, PhD, Principal investigator, King Chulalongkorn Memorial HospitalSaradee Warit, PhD, Principal investigator, King Chulalongkorn Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04552015
- Sponsor's protocol ID
- HIV-NAT 276
- Status last verified
- Feb 2023
- First submitted
- 10 Sep 2020
- Last updated
- 1 Mar 2023
- 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 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study for Development of Microneedles for Diagnosis of Latent Tuberculosis Infection
- ClinicalTrials.gov ID
- NCT04552015
- Acronym / sponsor ID
- HIV-NAT 276
- Conditions
- Latent Tuberculosis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: There is a problem with the investigational product
- Enrolment
- 4 participants (actual)
- Lead sponsor
- The HIV Netherlands Australia Thailand Research CollaborationUniversity, hospital or other
- Collaborators
- National Nanotechnology Center (NANOTEC), The National Science and Technology Development Agency (NSTDA)
- Study start
- 8 Apr 2021 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 17 Sep 2020 (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.
This study will evaluate new technique, microneedle, to detect latent tuberculosis (TB) in healthy volunteers
Detailed description
The cross-sectional study to investigate the effect of microneedle formulations and lengths of Tuberculin PPD microneedles on the delayed-type hypersensitivity response in healthy volunteers.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| volunteers | Other | Diagnostic Test: TST vs PPD microneedle testtwo different types of diagnostic tools (TST vs microneedle) will be used to screen for latent TB infection |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Sex : Male and Female
- Age : 20-60 years
- TB contacts or those at risk of TB e.g. health-care workers
- HIV-negative healthy individuals
Key exclusion criteria (4 listed)
- Presence of an acute infection, as determined by investigators
- Receiving immunosuppression drugs e.g. steroids
- Having autoimmune diseases e.g. SLE (Systemic Lupus Erythematous)
- Being pregnant or breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TST vs PPD microneedle testTST vs First patch: 800 um in length, PPD1 formulation; Second patch: 1,500 um in length, PPD1 formulation; Third patch: 800 um in length, PPD2 formulation; and Fourth patch: 1,500 um in length, PPD2 formulation | Diagnostic test | volunteers |
Primary outcome
size of induration at 48 hours post-PPD injection
Time frame: 48 hours
Monitoring the response of delayed-type hypersensitivity on the skin by comparing TST to microneedle tests
Results and safety
The study was stopped early (reason given: There is a problem with the investigational product). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2023.
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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.
Sivaporn Gatechompol, MD principal investigator
The HIV Netherlands Australia Thailand Research Collaboration
Jeerapond Leelawattanachai, PhD principal investigator
King Chulalongkorn Memorial Hospital
Saradee Warit, PhD principal investigator
King Chulalongkorn Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TST vs PPD microneedle test in people with Latent Tuberculosis, run by The HIV Netherlands Australia Thailand Research Collaboration 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 4 inclusion and 4 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: stopped early, as of the sponsor's last update on 1 Mar 2023. 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 was stopped early (reason given: There is a problem with the investigational product). Results are not available in the source record.
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?
size of induration at 48 hours post-PPD injection (time frame: 48 hours). 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 1 Mar 2023.