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Microneedles for Diagnosis of LTBI

Primary Purpose

Latent Tuberculosis

Status
Terminated
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
TST vs PPD microneedle test
Sponsored by
The HIV Netherlands Australia Thailand Research Collaboration
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Latent Tuberculosis

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesAccepts 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

Sites / Locations

  • Faculty of Medicine, Chulalongkorn University

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

volunteers

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 10, 2020
Last Updated
February 27, 2023
Sponsor
The HIV Netherlands Australia Thailand Research Collaboration
Collaborators
National Nanotechnology Center (NANOTEC), The National Science and Technology Development Agency (NSTDA)
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1. Study Identification

Unique Protocol Identification Number
NCT04552015
Brief Title
Microneedles for Diagnosis of LTBI
Official Title
Pilot Study for Development of Microneedles for Diagnosis of Latent Tuberculosis Infection
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Terminated
Why Stopped
There is a problem with the investigational product
Study Start Date
April 8, 2021 (Actual)
Primary Completion Date
October 1, 2022 (Actual)
Study Completion Date
October 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The HIV Netherlands Australia Thailand Research Collaboration
Collaborators
National Nanotechnology Center (NANOTEC), The National Science and Technology Development Agency (NSTDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Latent Tuberculosis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
volunteers
Arm Type
Other
Arm Description
two different types of diagnostic tools (TST vs microneedle) will be used to screen for latent TB infection
Intervention Type
Diagnostic Test
Intervention Name(s)
TST vs PPD microneedle test
Intervention Description
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
Primary Outcome Measure Information:
Title
size of induration at 48 hours post-PPD injection
Description
Monitoring the response of delayed-type hypersensitivity on the skin by comparing TST to microneedle tests
Time Frame
48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Sex : Male and Female Age : 20-60 years TB contacts or those at risk of TB e.g. health-care workers HIV-negative healthy individuals Exclusion Criteria: Presence of an acute infection, as determined by investigators Receiving immunosuppression drugs e.g. steroids Having autoimmune diseases e.g. SLE (Systemic Lupus Erythematous) Being pregnant or breastfeeding
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sivaporn Gatechompol, MD
Organizational Affiliation
The HIV Netherlands Australia Thailand Research Collaboration
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jeerapond Leelawattanachai, PhD
Organizational Affiliation
King Chulalongkorn Memorial Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Saradee Warit, PhD
Organizational Affiliation
King Chulalongkorn Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine, Chulalongkorn University
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand

12. IPD Sharing Statement

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Microneedles for Diagnosis of LTBI

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