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C-TST for Diagnosis of Latent Mycobacterium Tuberculosis Infection in Indonesia

NCT07587164 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2026-05-15

No results posted yet for this study

Summary

This is an operational research in household/close contacts of confirmed TB patients to evaluate the effectiveness of C-TST compared to IGRA test in identifying latent TB cases using parameters of effectiveness and safety.

Conditions

  • Latent Tuberculosis Infection (LTBI)

Interventions

DRUG

Recombinant Mycobacterium Tuberculosis Fusion Protein Tuberculin Skin Test (C-TST)

The study was a prospective, open-label, non-randomized study. All subjects underwent IGRA testing (QFT), followed by C-TST administration. T-SPOT.TB tests were performed only in cases of any discrepancies in the results between C-TST and QFT and were used as part of a composite reference standard. Subjects then underwent blood collection (6 mL venous blood) using lithium-heparin tube for IGRA Quantiferon® testing, followed by administration of 0.1 mL 5 U C-TST intradermally on the palm side of the forearm using Mantoux method on Day 1. Blood collection and administration of C-TST were performed by an authorized site nurse from each site.

Sponsors & Collaborators

  • Indonesian Respiratory Research and Training Foundation

    collaborator OTHER

  • Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-05-26
Primary Completion
2025-08-21
Completion
2025-08-21

Countries

  • Indonesia

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07587164 on ClinicalTrials.gov