Microneedles for Diagnosis of LTBI

February 27, 2023 updated by: The HIV Netherlands Australia Thailand Research Collaboration

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

4

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10330
        • Faculty of Medicine, Chulalongkorn University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The HIV Netherlands Australia Thailand Research Collaboration

Collaborators

National Nanotechnology Center (NANOTEC), The National Science and Technology Development Agency (NSTDA)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 8, 2021

Primary Completion (Actual)

October 1, 2022

Study Completion (Actual)

October 1, 2022

Study Registration Dates

First Submitted

September 10, 2020

First Submitted That Met QC Criteria

September 15, 2020

First Posted (Actual)

September 17, 2020

Study Record Updates

Last Update Posted (Actual)

March 1, 2023

Last Update Submitted That Met QC Criteria

February 27, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HIV-NAT 276

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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