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

Anhui Zhifei Longcom

Status: Completed

Conditions: Latent Tuberculosis Infection (LTBI)

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07587164

CTST-INA-001

Details and patient eligibility

About

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.

Full description

The study is designed as an operational research. After informed consent and screening by evaluation of medical history followed by thorough physical examination and vital signs test (body temperature, blood pressure, pulse rate, and respiration rate) and urine pregnancy test for women of childbearing potential, blood collection will be done in 300 eligible subjects for IGRA test, followed by C-TST skin test. Measure the body temperature of all subjects 30 min after the skin test. Test results will be observed with skin reaction at the injection site 48~72 h after the skin test. Test results along with presence of adverse events until 7 days follow-up will be recorded. If there are discrepancies in the test result, a T-SPOT test will be conducted after the skin test.

Enrollment: 300 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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300 participants in 1 patient group

Diagnostic Testing Arm

Experimental group

Description:

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.

Treatment:

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