Cy-Tb for Detecting Mycobacterium Tuberculosis Infection in Indonesian Population

Trial details

Who runs it

PT Bio Farma

Trial code

NCT07929285

Record updated

2026. november 10.

Original description

TB is caused by the bacillus Mycobacterium tuberculosis, which is spread when people who are sick with TB expel bacteria into the air (e.g. by droplet or coughing). About a quarter of the global population is estimated to have been infected with TB. Following infection, the risk of developing TB disease is highest in the first 2 years (approximately 5%), after which it is much lower. Some people will clear the infection. Of the total number of people who develop TB disease each year, about 90% are adults, with more cases among men than women. The disease typically affects the lungs (pulmonary TB) but can affect other sites as well. Passive detection of TB through healthcare facility attendance alone is inadequate to identify all individuals with TB disease. Ongoing case-detection gaps, particularly in vulnerable groups, along with diagnostic delays and continued community transmission, emphasize the need for more active TB case-finding strategies. Systematic screening for TB disease among populations at high risk is a core element of the first pillar of the WHO End TB Strategy, aiming to promote the early identification and diagnosis of all individuals with TB.Read full original descriptionShow less

TB is caused by the bacillus Mycobacterium tuberculosis, which is spread when people who are sick with TB expel bacteria into the air (e.g. by droplet or coughing). About a quarter of the global population is estimated to have been infected with TB. Following infection, the risk of developing TB disease is highest in the first 2 years (approximately 5%), after which it is much lower. Some people will clear the infection. Of the total number of people who develop TB disease each year, about 90% are adults, with more cases among men than women. The disease typically affects the lungs (pulmonary TB) but can affect other sites as well. Passive detection of TB through healthcare facility attendance alone is inadequate to identify all individuals with TB disease. Ongoing case-detection gaps, particularly in vulnerable groups, along with diagnostic delays and continued community transmission, emphasize the need for more active TB case-finding strategies. Systematic screening for TB disease among populations at high risk is a core element of the first pillar of the WHO End TB Strategy, aiming to promote the early identification and diagnosis of all individuals with TB.

This study aims to compare the Cy-Tb test with the IGRA (blood test) to detect TB infection in individuals who are close contacts and household contacts of patients with TB. The study also aims to evaluate the safety of the Cy-Tb test, the costs and benefits of its use, and participants' opinions regarding the Cy-Tb test compared with the IGRA.

Inclusion: Age 1-65 years old being closed contact and household with person diagnosed with pulmonary TB; Subject/Parents/legal guardian(s) have been informed properly regarding the study and signed the informed consent/assent form; Subject/Parents/legal guardian(s) will commit to comply with the instructions of the investigator and the schedule of the study.

Exclusion: History of confirmed or suspected immunosuppressive or immunodeficient state or in the previous 4 weeks received a treatment likely to alter the immune response (intravenous immunoglobulins, blood-derived products, or long-term corticosteroid therapy (> 2 weeks)); Subjects with HIV and other immunocompromised diseases; Have history of TB disease; Patients with acute infectious disease (such as measles, whooping cough, influenza, pneumonia, etc), acute conjunctivitis, acute otitis media, extensive skin disease, and allergic constitution; Patients with serious chronic diseases (serious cardiovascular diseases, uncontrolled hypertension and diabetes, liver and kidney diseases, malignant tumors, etc.) which according to the investigator might interfere with the assessment of the trial objectives; Current skin conditions that could interfere with the measurement of induration after the Cy-TB; History of uncontrolled coagulopathy or blood disorders contraindicating for phlebotomy; Allergic constitution (allergic to various drugs or foods); history of severe systemic reaction caused by allergy to drugs, biological products or any other reason; history of allergy to any of the following substances: any component of the preparation, human serum albumin, vaccines, serums, immunoglobulins, antibodies, sedative/hypnotic agents, yeast products or alcohol; Individuals aged more than equal 15 years who on anti-TB treatment/TPT during enrollment; Concomitantly enrolled or scheduled to be enrolled in another study; Pregnancy test positive. Adult female subjects in lactation or positive in pregnancy test in time of the screening period or the study; Receive any tuberculin skin test within three months; Subjects plan to move from the study area before the end of study period; Subjects with any other factor ineligible for the study, as deemed by the Investigator.

ClinicalTrials.gov NCT07929285