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

Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.300 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

300

Conditions

Latent Tuberculosis Infection (LTBI)

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

RSUP Persahabatan (Persahabatan General Hospital)

Jakarta, Jakarta Timur (East Jakarta), Indonesia

Outcomes

Primary Outcomes

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.

Time frame: 7 days after the skin test

Secondary Outcomes

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

1. Overall incidence of AEs; 2. Immediate AEs within 30 minutes after skin test injection; 3. Incidence of AEs related to the investigational product; 4. Incidence of AEs ≥ grade 3; 5. Incidence of AEs ≥ grade 3 related to the investigational product; 6. Incidence of AEs leading to withdrawal; 7. Incidence of AEs related to the investigational product leading to withdrawal; Incidence of all serious adverse events (SAEs) and incidence of SAEs related to the investigational product within 7 days after the skin test.

Time frame: within 7 days after the skin test

Incremental Cost Effectiveness Ratio

On the third visit, subjects will be asked to fill out an acceptability questionnaire. In additional to assess cost-effectiveness, investigator will use primary data obtained from health workers (doctors, nurses, and laboratory workers) as well as cost summary used in laboratories. Other data will be obtained from secondary data and model assumptions.

Time frame: Day 7 after skin test

Data from ClinicalTrials.gov

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