Microneedles for Diagnosis of LTBI

N/ATerminatedNCT04552015

The HIV Netherlands Australia Thailand Research Collaboration4 enrolled

Overview

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

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

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Latent Tuberculosis

Interventions

TST vs PPD microneedle testDIAGNOSTIC_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

Eligibility

Sex: ALLMin age: 20 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Faculty of Medicine, Chulalongkorn University

Bangkok, Thailand

Outcomes

Primary Outcomes

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

Time frame: 48 hours

Data from ClinicalTrials.gov

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