Clinical Research Directory
Browse clinical research sites, groups, and studies.
C-TST for Diagnosis of Latent Mycobacterium Tuberculosis Infection in Indonesia
Sponsor: Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
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.
Official title: Operational Research of Recombinant Mycobacterium Tuberculosis Fusion Protein Tuberculin Skin Test (C-TST) for Diagnosis of Latent Mycobacterium Tuberculosis Infection in Populations Aged 18 Years to 65 Years Old in Indonesia
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
300
Start Date
2025-05-26
Completion Date
2025-08-21
Last Updated
2026-06-03
Healthy Volunteers
Yes
Conditions
Interventions
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.
Locations (1)
RSUP Persahabatan (Persahabatan General Hospital)
Jakarta, Jakarta Timur (East Jakarta), Indonesia