Microneedles for Diagnosis of LTBI

The HIV Netherlands Australia Thailand Research Collaboration

Status: Terminated

Conditions: Latent Tuberculosis

Treatments: Diagnostic Test: TST vs PPD microneedle test

Study type: Interventional

Funder types: Other

Identifiers

NCT04552015

HIV-NAT 276

Details and patient eligibility

About

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

Full 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.

Enrollment: 4 patients

Sex: All

Ages: 20 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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4 participants in 1 patient group

volunteers

Other group

Description:

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

Treatment:

Diagnostic Test: TST vs PPD microneedle test