Latent Tuberculosis Infection (LTBI)C-TSTNCT07587164

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

A study testing Recombinant Mycobacterium Tuberculosis Fusion Protein Tuberculin Skin Test (C-TST) in people with Latent Tuberculosis Infection (LTBI), run by Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. at 1 site in Indonesia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Latent Tuberculosis Infection (LTBI)
What is being tested?: Recombinant Mycobacterium Tuberculosis Fusion Protein Tuberculin Skin Test (C-TST)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 300 participants
Where: 1 siteIndonesia
Study dates: 26 May 2025to 21 Aug 2025
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Indonesia1 site

RSUP Persahabatan (Persahabatan General Hospital)
Jakarta, Jakarta Timur (East Jakarta), 13220

Other trials in Indonesia

About this study

Official title: Operational Research of Recombinant Mycobacterium Tuberculosis Fusion Protein Tuberculin Skin Test (C-TST) for Diagnosis of Latent Mycobacterium Tuberculosis Infection in Populations Aged 18 Years to 65 Years Old in Indonesia

Read the detailed 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.

Conditions: Latent Tuberculosis Infection (LTBI)
Being tested: Recombinant Mycobacterium Tuberculosis Fusion Protein Tuberculin Skin Test (C-TST)
Keywords: Tuberculosis, Latent tuberculosis infection, CTST, IGRA, Diagnostic concordance
Medical subject headings: Latent Tuberculosis, Tuberculosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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.

Study groups in NCT07587164
Study group	Role	What they receive
Diagnostic Testing Arm	Experimental	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. Receives: Drug: Recombinant Mycobacterium Tuberculosis Fusion Protein Tuberculin Skin Test (C-TST)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 7 days after the skin test

Secondary outcomes (2)

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.
Measured: 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.
Measured: Day 7 after skin test

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 May 202521 Aug 2025

First posted14 May 2026
Study start26 May 2025
Primary completion21 Aug 2025
Study completion21 Aug 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Latent Tuberculosis Infection (LTBI)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 300 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07587164
Sponsor's protocol ID: CTST-INA-001
Acronym: C-TST
Status last verified: May 2026
First submitted: 8 May 2026
Last updated: 3 Jun 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Latent Tuberculosis Infection (LTBI) trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Operational Research of Recombinant Mycobacterium Tuberculosis Fusion Protein Tuberculin Skin Test (C-TST) for Diagnosis of Latent Mycobacterium Tuberculosis Infection in Populations Aged 18 Years to 65 Years Old in Indonesia
ClinicalTrials.gov ID: NCT07587164
Acronym / sponsor ID: C-TST / CTST-INA-001
Conditions: Latent Tuberculosis Infection (LTBI)
Keywords: Tuberculosis, Latent tuberculosis infection, CTST, IGRA, Diagnostic concordance
Study type: Interventional
Recruitment status: Completed
Enrolment: 300 participants (actual)
Lead sponsor: Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.Industry (pharma, biotech, devices)
Collaborators: Respiratory Programmatic Implementation and Research Institute (RPRI)
Study start: 26 May 2025 (actual)
Primary completion: 21 Aug 2025 (actual)
Study completion: 21 Aug 2025 (actual)
First posted: 14 May 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Diagnostic Testing Arm	Experimental	Drug: Recombinant Mycobacterium Tuberculosis Fusion Protein Tuberculin Skin Test (C-TST)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.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (8 listed)

Pregnant or lactating women
Individuals with active TB or those presenting symptoms suggestive of TB.
Patients with acute infectious diseases (such as measles, whooping cough, influenza, pneumonia, etc), acute conjunctivitis, acute otitis media, extensive skin diseases, and allergic constitution.
Have a history of TB disease
Received a TST within the last 6 months

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Recombinant Mycobacterium Tuberculosis Fusion Protein Tuberculin Skin Test (C-TST)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.	Drug	Diagnostic Testing Arm

Primary outcome

Acceptance rate between C-TST and IGRA test in identifying latent TB infection in household and close contact populations.
Time frame: 7 days after the skin test
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.

2 secondary outcomes

Safety endpoints: Incidence of all AEs within 7 days after skin test injection.
Time frame: within 7 days after the skin test
Incremental Cost Effectiveness Ratio
Time frame: Day 7 after skin test

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
Individual participant dataSharing planned: No

Related trials for Latent Tuberculosis Infection (LTBI)

RecruitingPhase 1/2
A Study of Daily Rifapentine Combined With Isoniazid (1HP) for Tuberculosis Prevention in Children Less Than 13 Years of Age With and Without HIV
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RecruitingPhase 2/3
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RecruitingPhase 2
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Recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Acceptance rate between C-TST and IGRA test in identifying latent TB infection in household and close contact populations. (time frame: 7 days after the skin test). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07587164.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.