Microneedles for Diagnosis of LTBI
Overview
This study will evaluate new technique, microneedle, to detect latent tuberculosis (TB) in healthy volunteers
Full Title of Study: “Pilot Study for Development of Microneedles for Diagnosis of Latent Tuberculosis Infection”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: N/A
- Intervention Model: Single Group Assignment
- Primary Purpose: Diagnostic
- Masking: None (Open Label)
- Study Primary Completion Date: October 1, 2022
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.
Interventions
- 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
Arms, Groups and Cohorts
- Other: volunteers
- two different types of diagnostic tools (TST vs microneedle) will be used to screen for latent TB infection
Clinical Trial Outcome Measures
Primary Measures
- 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
Participating in This Clinical Trial
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
Gender Eligibility: All
Minimum Age: 20 Years
Maximum Age: 60 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
Investigator Details
- Lead Sponsor
- The HIV Netherlands Australia Thailand Research Collaboration
- Collaborator
- National Nanotechnology Center (NANOTEC), The National Science and Technology Development Agency (NSTDA)
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- 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
Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.