Microneedles for Diagnosis of LTBI

Not Applicable

Terminated

• Conditions: Latent Tuberculosis
• Interventions: Diagnostic Test: TST vs PPD microneedle test

• Registration Number: NCT04552015
• Lead Sponsor: The HIV Netherlands Australia Thailand Research Collaboration

Brief Summary

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

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 Timeline

• Study First Submitted: 2020-09-10
• Study First Submitted QC: 2020-09-15
• Study First Posted: 2020-09-17
• Study Start: 2021-04-08
• Primary Completion: 2022-10-01
• Study Completion: 2022-10-01
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-27
• Last Update Posted: 2023-03-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
volunteers	TST vs PPD microneedle test	two different types of diagnostic tools (TST vs microneedle) will be used to screen for latent TB infection

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Faculty of Medicine, Chulalongkorn University; 🇹🇭 Bangkok, Thailand