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NCT07587164Completed

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

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

Source: ClinicalTrials.gov · Last updated 3 Jun 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
300 (actual)
First submitted
8 May 2026
Start date
26 May 2025
Primary completion date
21 Aug 2025
Lead sponsor
Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
Diseases
Tuberculosis
NCT number
NCT07587164

What you commit to

  • Study type: Interventional
  • Participants enrolled: 300
  • From 26 May 2025 to the primary completion date, 21 Aug 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Received a TST within the last 6 months
  • Currently participating in a clinical trial for medication.

Other illness

  • 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
  • Presence of skin conditions that might interfere with the interpretation after C-TST administration, such as tattoo and abnormal skin condition.
  • Condition where researchers believe that there are any situations that may affect the evaluation of the trial.

Other

  • Pregnant or lactating women
  • Individuals with active TB or those presenting symptoms suggestive of TB.

Who the study is looking for

  • 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)

Age in the registry: 18 years to 65 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
RSUP Persahabatan (Persahabatan General Hospital)
Coordinator of this site? Confirm its status
JakartaIndonesiaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.