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NCT04552015 Clinical Trial

Microneedles for Diagnosis of LTBI

Latent Tuberculosis Clinical Trial

Official title:
Pilot Study for Development of Microneedles for Diagnosis of Latent Tuberculosis Infection

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT04552015
Other study ID # HIV-NAT 276
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date April 8, 2021
Est. completion date October 1, 2022

Study information
Verified date February 2023
Source The HIV Netherlands Australia Thailand Research Collaboration
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will evaluate new technique, microneedle, to detect latent tuberculosis (TB) in healthy volunteers

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.

Recruitment information / eligibility
Status Terminated
Enrollment 4
Est. completion date October 1, 2022
Est. primary completion date October 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 60 Years
Eligibility Inclusion Criteria: 1. Sex : Male and Female 2. Age : 20-60 years 3. TB contacts or those at risk of TB e.g. health-care workers 4. HIV-negative healthy individuals Exclusion Criteria: 1. Presence of an acute infection, as determined by investigators 2. Receiving immunosuppression drugs e.g. steroids 3. Having autoimmune diseases e.g. SLE (Systemic Lupus Erythematous) 4. Being pregnant or breastfeeding

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• TST vs PPD microneedle 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

Locations
Country Name City State
Thailand Faculty of Medicine, Chulalongkorn University Bangkok

Sponsors (2)
Lead Sponsor Collaborator
The HIV Netherlands Australia Thailand Research Collaboration National Nanotechnology Center (NANOTEC), The National Science and Technology Development Agency (NSTDA)

Country where clinical trial is conducted

Thailand, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 48 hours
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