Could a new skin test better detect TB in seniors?
NCT ID NCT05899179
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested a new skin test called EC to see if it can accurately diagnose tuberculosis (TB) infection in adults aged 65 and older. Researchers compared EC with a standard TB skin test (TB-PPD) and a blood test (T-SPOT) in 780 participants, including TB patients and healthy volunteers. The goal was to see how well EC detects infection and whether it causes any side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Recombinant Mycobacterium Tuberculosis Fusion Protein (EC) injection
- What this could lead to
- If successful, this could provide a more accurate skin test for detecting tuberculosis infection in older adults, improving diagnosis and treatment.
- What could go wrong
- This is a completed phase 3 trial, but results are not yet published. The test may not be significantly better than existing methods, and skin reactions can vary.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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780 people
The number who actually took part.
- Started
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Aug 2023
- Finished
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Sep 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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65 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 65 years old and above (≥ 65 years old), male or female, the subjects themselves voluntarily participate in this study, sign the informed consent form, and can understand and comply with the requirements of the trial protocol to participate in follow-up. * Normal underarm body temperature (\< 37.3 °C); * Tuberculosis patients: pulmonary tuberculosis patients and extrapulmonary tuberculosis patients diagnosed by researchers as confirmed cases of tuberculosis and clinically diagnosed cases. Refer to the "WS288-2017 Tuberculosis Diagnostic Criteria" to formulate the diagnostic criteria for pulmonary tuberculosis in this protocol, see Annex 1 for details; The diagnostic criteria for extrapulmonary tuberculosis were formulated with reference to the Technical Guidelines for Tuberculosis Prevention and Control in China (2021 edition of the Chinese Center for Disease Control and Prevention), as detailed in Annex 2. * Non-tuberculous community population with other lung diseases: there is a clear lung disease, but the study physician can exclude pulmonary tuberculosis based on the patient's clinical manifestations, chest imaging and laboratory tests. Diagnostic criteria for their main types of nontuberculous other lung diseases can be found in Annex 3; * Community healthy people without other lung diseases: those who have no history of tuberculosis, no suspicious symptoms of tuberculosis, no history of respiratory tract and recent respiratory symptoms, and no obvious abnormalities in both lungs on chest imaging (DR) examination; After consultation, there is no history of heart, liver, kidney, digestive tract, nervous system, or psychiatric abnormalities. Exclusion Criteria: * Combined with the following serious diseases, such as advanced tumors, acute exacerbation of chronic obstructive pulmonary disease, acute or progressive liver disease or kidney disease, decompensated stage of congestive heart failure, autoimmune diseases (except those who do not need to use immune agents in the stable period), primary immunodeficiency diseases, etc.; * Those suffering from acute infectious diseases (such as measles, pertussis, influenza, pneumonia, etc.), acute conjunctivitis, acute otitis media, extensive skin diseases and allergies; * Those with known or suspected (or high-risk occurrence possibility) immune impairment or abnormalities, such as those receiving immunosuppressants or immune booster therapy, receiving glucocorticoids, immunoglobulin preparations other than the gastrointestinal tract or blood products or plasma extracts within 1 month; * Those who have positive human immunodeficiency virus (HIV) antibody test results; * Those who are participating in other new drug clinical trials or have participated in any other new drug clinical trials within 3 months before this clinical trial; * Fasting blood glucose ≥ 10mmol/L after drug control; * Blood pressure range: systolic blood pressure ≥ 180 mmHg and (or) diastolic blood pressure ≥ 110 mmHg (those who take drugs are uncontrollable); * Any situation that the investigator believes is poor adherence or may affect the evaluation of the trial.
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Anhui Chest Hospital
Hefei, Anhui, China
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Changsha Central Hospital
Changsha, Hunan, China
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Guangzhou Municipal Hospital of Chest Medicine
Guangzhou, Guangdong, China
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LiuZhou People's Hospital
Liuzhou, Guangxi, China
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The First Affiliated Hospital of Bengbu Medical University
Bengbu, Anhui, China
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The Third People's Hospital Of Shenzhen
Shenzhen, Guangdong, China
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Wuhan Institute for Tuberculosis Control
Wuhan, China
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Wuxi NO.5 People's Hospital
Wuxi, Jiangsu, China
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