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

NCT07587164 | Completed

• 1 other identifier: CTST-INA-001
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

Tuberculosis; Latent tuberculosis infection; CTST; IGRA; Diagnostic concordance

Outcome Measures

Primary Outcomes (1)

• Acceptance rate between C-TST and IGRA test in identifying latent TB infection in household and close contact populations.

  The primary outcome is the concordance between C-TST and QuantiFERON-TB (QFT) results. All subjects underwent QFT testing followed by 0.1 mL 5 U C-TST administered intradermally on the forearm using the Mantoux method. In cases of discrepant results between C-TST and QFT, T-SPOT.TB testing was performed as part of a composite reference standard. Concordance will be calculated based on agreement rates between the tests.

  7 days after the skin test

Secondary Outcomes (2)

• Safety endpoints: Incidence of all AEs within 7 days after skin test injection.

  within 7 days after the skin test

• Incremental Cost Effectiveness Ratio

  Day 7 after skin test

Study Arms (1)

Diagnostic Testing Arm

EXPERIMENTAL

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.

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

Interventions

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

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.

Diagnostic Testing Arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Participants must self-identify as the gender corresponding to their biological sex at birth.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years - 65 years old
• Being a close contact or household contact of a TB patient
• Subject and/or legally acceptable representatives of the subject are willing to participate in the research by providing informed consent.
• On the day of enrollment, the axillary body temperature was normal (\<37.3 °C)

You may not qualify if:

• Pregnant or lactating women
• Individuals with active TB or those presenting symptoms suggestive of TB.
• Patients with acute infectious diseases (such as measles, whooping cough, influenza, pneumonia, etc), acute conjunctivitis, acute otitis media, extensive skin diseases, and allergic constitution.
• Have a history of TB disease
• Received a TST within the last 6 months
• Presence of skin conditions that might interfere with the interpretation after C-TST administration, such as tattoo and abnormal skin condition.
• Currently participating in a clinical trial for medication.
• Condition where researchers believe that there are any situations that may affect the evaluation of the trial.

Sponsors & Collaborators

• Respiratory Programmatic Implementation and Research Institute (RPRI): collaborator
• Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.: lead

Study Sites (1)

RSUP Persahabatan (Persahabatan General Hospital)

Jakarta, Jakarta Timur (East Jakarta), 13220, Indonesia

Location

MeSH Terms

Conditions

Latent Tuberculosis; Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Latent Infection

Study Design

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

Study Record Dates

• First Submitted: May 8, 2026
• First Posted: May 14, 2026
• Study Start: May 26, 2025
• Primary Completion: August 21, 2025
• Study Completion: August 21, 2025
• Last Updated: June 3, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)