Microneedles for Diagnosis of LTBI

Sponsor
The HIV Netherlands Australia Thailand Research Collaboration (Other)
Overall Status
Recruiting
CT.gov ID
NCT04552015
Collaborator
National Nanotechnology Center (NANOTEC), The National Science and Technology Development Agency (NSTDA) (Other)
120
1
1
17.8
6.8

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: TST vs PPD microneedle test
N/A

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

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Pilot Study for Development of Microneedles for Diagnosis of Latent Tuberculosis Infection
Actual Study Start Date :
Apr 8, 2021
Anticipated Primary Completion Date :
Oct 1, 2022
Anticipated Study Completion Date :
Oct 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Other: volunteers

two different types of diagnostic tools (TST vs microneedle) will be used to screen for latent TB infection

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

Outcome Measures

Primary Outcome Measures

  1. size of induration at 48 hours post-PPD injection [48 hours]

    Monitoring the response of delayed-type hypersensitivity on the skin by comparing TST to microneedle tests

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Faculty of Medicine, Chulalongkorn University Bangkok Thailand 10330

Sponsors and Collaborators

  • The HIV Netherlands Australia Thailand Research Collaboration
  • National Nanotechnology Center (NANOTEC), The National Science and Technology Development Agency (NSTDA)

Investigators

  • Principal Investigator: Sivaporn Gatechompol, MD, The HIV Netherlands Australia Thailand Research Collaboration
  • Principal Investigator: Jeerapond Leelawattanachai, PhD, King Chulalongkorn Memorial Hospital
  • Principal Investigator: Saradee Warit, PhD, King Chulalongkorn Memorial Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
The HIV Netherlands Australia Thailand Research Collaboration
ClinicalTrials.gov Identifier:
NCT04552015
Other Study ID Numbers:
  • HIV-NAT 276
First Posted:
Sep 17, 2020
Last Update Posted:
Aug 27, 2021
Last Verified:
Aug 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 27, 2021