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

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