NCT04552015

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 10, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 17, 2020

Completed
7 months until next milestone

Study Start

First participant enrolled

April 8, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
Last Updated

March 1, 2023

Status Verified

February 1, 2023

Enrollment Period

1.5 years

First QC Date

September 10, 2020

Last Update Submit

February 27, 2023

Conditions

Latent Tuberculosis

Outcome Measures

Primary Outcomes (1)

  • 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

    48 hours

Study Arms (1)

volunteers

OTHER

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

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

volunteers

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine, Chulalongkorn University

Bangkok, 10330, Thailand

Location

MeSH Terms

Conditions

Latent Tuberculosis

Condition Hierarchy (Ancestors)

TuberculosisMycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsLatent Infection

Study Officials

  • Sivaporn Gatechompol, MD

    The HIV Netherlands Australia Thailand Research Collaboration

    PRINCIPAL INVESTIGATOR

  • Jeerapond Leelawattanachai, PhD

    King Chulalongkorn Memorial Hospital

    PRINCIPAL INVESTIGATOR

  • Saradee Warit, PhD

    King Chulalongkorn Memorial Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2020

First Posted

September 17, 2020

Study Start

April 8, 2021

Primary Completion

October 1, 2022

Study Completion

October 1, 2022

Last Updated

March 1, 2023

Record last verified: 2023-02

Locations

TH(1)