Cy-Tb for Detecting Mycobacterium Tuberculosis Infection in Indonesian Population
TB Infection
What this study involves
The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.
- Study type
- Interventional
- Phase
- Not applicable
- Age range
- 1 years - 65 years
- Sex eligible
- All sexes
- Healthy volunteers
- Accepted
- Participants
- 350 Estimated
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
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.
Read the full description
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.
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
Inclusion Criteria:
- 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 Criteria:
- Concomitantly enrolled or scheduled to be enrolled in another study;
- Subjects with HIV and other immunocompromised diseases;
- Pregnancy test positive. Adult female subjects in lactation or positive in pregnancy test in time of the screening period or the study;
- Individuals aged more than equal 15 years who on anti-TB treatment/TPT during enrollment;
- 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;
- 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));
- 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;
- Receive any tuberculin skin test within three months;
- 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;
- 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.
Treatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Not applicable
- Masking
- No masking
Cy-Tb and IGRA Group
Not reported in this registry record.
Diagnostic Test: Cy-Tb test · Diagnostic Test: IGRA test
Cy-Tb test DIAGNOSTIC_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.
IGRA test DIAGNOSTIC_TEST
A small amount of blood will be collected from the participant's arm for IGRA testing.
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
Positive coincidence rate of Cy-Tb in comparison to IGRA test in identifying TB infection
Time frame: 48-72 hours
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.
Secondary measures
Negative coincidence rate of Cy-Tb in comparison to IGRA test in identifying TB infection
Time frame: 48-72 hours
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.
Adverse events within 28 days after Cy-Tb test
Time frame: 28 days
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.
Incremental Cost-Effectiveness Ratio
Time frame: 28 days
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.
Agreement rate between Cy-Tb and IGRA test in identifying TB infection
Time frame: 1 month
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.
Incidence of adverse events
Time frame: 28 days
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.
Immediate adverse events within 30 minutes after Cy-Tb test
Time frame: 30 minutes
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.
Serious adverse events within 28 days after Cy-Tb test
Time frame: 28 days
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.
Other measures
Acceptability of Cy-Tb test in identifying TB infection in TB close contacts and households
Time frame: 28 days
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.
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (1)
The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.
1 locations
Persahabatan HospitalJakarta Pusat, Jakarta Special Capital Region, IndonesiaStatus unknown
Study team and timeline
- Lead sponsor
- PT Bio Farma
- Study start
- Oct 12, 2026 Estimated
- Primary completion
- Jan 31, 2027 Estimated
- Study completion
- Jan 31, 2027 Estimated
- First posted
- Nov 10, 2026 Actual
- Last updated
- Nov 10, 2026 Actual
Official study contacts
Official study title
Cy-Tb for Detecting Mycobacterium Tuberculosis Infection in Indonesian Population
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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026