An interventional study of Cy-Tb test and IGRA test in TB Infection, sponsored by PT Bio Farma. Not yet recruiting at 1 site in Indonesia. Open to participants aged 1 Year to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by PT Bio Farma · Not applicable, Interventional, and Diagnostic
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.
Tuberculosis (TB), a preventable and treatable disease, continues to be a significant global health problem. In 2022, it was the second leading cause of death from a single infectious agent, claiming more lives than HIV/AIDS. With over 10 million people contracting TB annually, urgent action is necessary to achieve the UN and WHO's goal of eliminating TB by 2030.
The reported global number of people newly diagnosed with TB was 7.5 million in 2022. This is the highest number since WHO began global TB monitoring in 1995, above the pre-COVID baseline (and previous historical peak) of 7.1 million in 2019, and up from 5.8 million in 2020 and 6.4 million in 2021. The number in 2022 probably includes a sizeable backlog of people who developed TB in previous years, but whose diagnosis and treatment was delayed by COVID-related disruptions that affected access to and provision of health services. India, Indonesia, and Phillipines, which collectively accounted for a large share (more than 60%) of the g lobal reductions in the number of people newly diagnosed with TB in 2020 and 2021, all recovered to above 2019 levels in 2022. According to the Global TB Report published by WHO in 2023, Indonesia is in second place after India with 1,060,000 cases and 134,000 deaths. There are around 15 people who die from TB every hour in Indonesia.
TB screening, also referred to as active TB case finding, aims to facilitate the early detection of TB disease, allowing for timely diagnosis and initiation of appropriate treatment. This approach minimizes delays in care, improves treatment outcomes, reduces long-term health consequences, and alleviates the social and economic burden experienced by patients and their families. In addition, early identification and treatment of individuals with active TB reduce the duration of infectiousness, thereby limiting transmission within households, workplaces, schools, and other community settings. Consequently, TB screening contributes to reducing the incidence of TB infection as well as the overall incidence and prevalence of TB disease.
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.
This study is conducted by the Department of Child Health, Faculty of Medicine, Universitas Indonesia/Cipto Mangunkusumo General Hospital, Jakarta, and the Department of Pulmonology and Respiratory Medicine, Faculty of Medicine, Universitas Indonesia/Persahabatan General Hospital, Jakarta, with support from PT Bio Farma as the study sponsor.
PT Bio Farma is the lead sponsor of 47 studies on the registry; 7 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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The human immunodeficiency virus, which weakens the immune system.
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A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
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Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Diagnostic Test: Cy-Tb test · Diagnostic Test: IGRA test
Participants will undergo a small Cy-Tb injection into the skin of the arm. Participants and their parents/guardians will receive a card to record any local symptoms, such as redness or itching, following the injection.
A small amount of blood will be collected from the participant's arm for IGRA testing.
Positive coincidence rate of Cy-Tb in comparison to IGRA test in identifying TB infection
The induration should be measured 48-72 hours after the injection. Measure the diameter of the induration transversely to the long axis of the forearm with a caliper. Normally the induration and erythema will decrease after 4 days and disappear within 28 days after the injection. An induration of ≥ 5 mm in Cy-Tb is considered as a positive result, which indicates infection with Mycobacterium tuberculosis. The induration can be seen as a raised area with clearly defined margin at and around the injection site. Although erythema can accompany the induration, only the induration should be measured. The main trial objectives were to compare the positive coincidence rate of Cy-Tb to IGRA test in identifying TB infection.
Time frame: 48-72 hours
Negative coincidence rate of Cy-Tb in comparison to IGRA test in identifying TB infection
The proportion of participants with a positive Cy-Tb test result (induration ≥5 mm) compared with the IGRA test result in identifying Mycobacterium tuberculosis infection. The Cy-Tb induration will be measured transversely to the long axis of the forearm using a caliper. Only induration will be measured, excluding erythema.
Time frame: 48-72 hours
Adverse events within 28 days after Cy-Tb test
The number and proportion of participants experiencing adverse events following Cy-Tb administration within 28 days after injection. Adverse events will be monitored and recorded throughout the 28-day follow-up period, including the occurrence, severity, duration, and relationship to Cy-Tb administration, where applicable.
Time frame: 28 days
Incremental Cost-Effectiveness Ratio
The incremental cost-effectiveness ratio (ICER) will be calculated by comparing the difference in costs between Cy-Tb and IGRA with the difference in their effectiveness in identifying Mycobacterium tuberculosis infection. The ICER represents the additional cost required to achieve one additional unit of effectiveness when using Cy-Tb compared with IGRA.
Time frame: 28 days
Agreement rate between Cy-Tb and IGRA test in identifying TB infection
The proportion of participants with concordant results between the Cy-Tb test and IGRA test in identifying Mycobacterium tuberculosis infection. Agreement will be assessed by comparing the positive and negative results of both tests. The agreement rate will be calculated as the number of participants with concordant test results divided by the total number of participants tested with both methods, expressed as a percentage.
Time frame: 1 month
Incidence of adverse events
The incidence and proportion of participants experiencing adverse events following Cy-Tb administration. Adverse events will be recorded, including their type, frequency, severity, duration, and relationship to Cy-Tb administration, where applicable.
Time frame: 28 days
Immediate adverse events within 30 minutes after Cy-Tb test
The number and proportion of participants experiencing immediate adverse events within 30 minutes after Cy-Tb intradermal injection. Participants will be monitored for any immediate adverse events, including local or systemic reactions, during the 30-minute observation period.
Time frame: 30 minutes
Serious adverse events within 28 days after Cy-Tb test
The number and proportion of participants experiencing serious adverse events (SAEs) within 28 days after Cy-Tb administration. Serious adverse events will be assessed based on their seriousness, including events resulting in death, life-threatening conditions, hospitalization or prolongation of existing hospitalization, persistent or significant disability, or congenital anomalies. The relationship between the serious adverse events and Cy-Tb administration will also be assessed.
Time frame: 28 days
Acceptability of Cy-Tb test in identifying TB infection in TB close contacts and households
The acceptability of the Cy-Tb test among tuberculosis (TB) close contacts and household contacts will be assessed based on participants' willingness to undergo the test, completion of the test procedure, and willingness to undergo the test again if needed. Acceptability will be evaluated using participant responses collected during the study.
Time frame: 28 days
Plan to share: No
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Start is estimated for Oct 2026; primary completion for Jan 2027, 3 months later.
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