Tuberculosis
Conditions
Keywords
diagnosis of tuberculosis, ESAT6-CFP10, skin test, diagnostic test
Brief summary
720 cases TB (Tuberculosis patients) participants、360 cases non-TB participants with lung disease and suspected TB patients who all meet the standard are divided into different groups through a randomized and blind method. Every subject inject intradermally ESAT6-CFP10 and TB-PPD (tuberculin purified protein derivative) in different arms of the same person by blind method. Specific gama-interferon (γ-IFN) detection is needed before the injection.Measure the induration and (or) redness of longitudinal diameter size and transverse diameter vernier caliper by vernier caliper after injection 24h, 48h and 72h. At the same time, we observe all kind of adverse events.
Detailed description
Firstly, 720 cases TB (Tuberculosis) participants who meet the standard respectively are divided into different groups through a randomized and blind method. 1. ESAT6-CFP10(10ug/ml) in left arm 2. ESAT6-CFP10(10ug/ml) in right arm. Inject intradermally ESAT6-CFP10 and TB-PPD in different arms of the same participant. For each of participant, the person in this clinical research, the study uniform is that every subject injects firstly left arm, observe no obvious adverse reaction, then another drug inject in right arm. Measure the induration and (or) redness of longitudinal diameter size and transverse diameter vernier caliper by vernier caliper after injection 24h, 48h and 72h. At the same time, we observe the vital signs (breathing, heart rate, blood pressure and temperature), local reactions (rash, pain, itching and skin mucous membrane) and a variety of adverse events. Secondly, 360 cases non-TB participants with lung disease and suspected TB participants are divided into two different groups and the procedure are as the same as 720 cases TB. Thirdly,suspected TB participants are put under TB (Tuberculosis patients) or non-TB participants with lung disease by diagnosis when out group. Finally, we calculate the sensitivity (positive coincidence rate) by TB (Tuberculosis patients), the specificity (negative coincidence rate) by non-TB participants with lung disease, and verify the safety and effectiveness of ESAT6-CFP10(10ug/ml) for the clinical auxiliary diagnosis of tuberculosis.
Interventions
BIOLOGICALESAT6-CFP10 (10ug/ml) in left arm and TB-PPD in right arm
All subjects including TB subjects and non-TB subjects with lung disease inject ESAT6-CFP10 (10ug/ml) in left arm and TB-PPD in right arm respectively. Two drug must use at the same participant and in different arms.
BIOLOGICALESAT6-CFP10 (10ug/ml) in right arm and TB-PPD in left arm
All subjects including TB subjects and non-TB subjects with lung disease inject ESAT6-CFP10 (10ug/ml) in right arm and TB-PPD in left arm respectively. Two drug must use at the same participant and in different arms.
Sponsors
Shanghai Public Health Clinical Center
Tianjin Haihe Hospital
Air Force Military Medical University, China
Proswell Medical Corporation
Wuhan Institute for Tuberculosis Control
Beijing Chest Hospital
Wuxi Hospital for Infectious Diseases
First Affiliated Hospital of Chongqing Medical University
Fuzhou Pulmonary Hospital of Fujian
Zhenjiang Third People's Hospital
Anhui Provincial Hospital
Shenzhen Third People's Hospital
Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
of TB (tuberculosis:include pulmonary tuberculosis and extra pulmonary tuberculosis) subjects: * judge the pulmonary tuberculosis patient according to Health industry standard of the People's Republic of China WS288-2008:Diagnostic Criteria for pulmonary tuberculosis; * 18 to 65 years old ,no gender limited; * Consent and signed informed consent forms (ICF); * Comply with follow-up. Inclusion Criteria of extra pulmonary tuberculosis subjects: * Diagnosed extra pulmonary tuberculosis by epidemiology, imaging, clinical symptoms, pathological examination and so on; * Lesions outside the lungs; * be in unfinished reinforced phase by chemotherapy;
Exclusion criteria
of TB (tuberculosis) subjects: * Accompanied by the following severe illness:advanced cancer, diabetes, copd in acute episodes, acute/progressive liver disease or kidney disease, congestive heart failure, ect; * Taking part in other clinical or within three months involved in any other clinical; * Severe allergic constitution:allergic to two or more drugs; * in pregnancy or lactation; * in a mental illness; * Any conditions affect the trial evaluation by investigator's judgement. Inclusion Criteria of non-TB participants with lung disease: * A clear lung disease but can exclude pulmonary tuberculosis by clinical symptoms, imaging, laboratory examination. * 18 to 65 years old, no gender limited; * Consent and signed informed consent forms (ICF); * Comply with follow-up.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Immune response of left arm (random injected ESAT6-CFP10 or PPD) from the size of induration or redness in TB patients | within 72h after injection | We measure the size of induration or redness at 24h, 48h, 72h after administered intradermally left arm (random injected ESAT6-CFP10 or PPD) |
| Immune response of right arm (random injected ESAT6-CFP10 or PPD) from the size of induration or redness in TB patients | within 72h after injection | We measure the size of induration or redness at 24h, 48h, 72h after administered intradermally right arm (random injected ESAT6-CFP10 or PPD) |
| Immune response of left arm (random injected ESAT6-CFP10 or PPD) from the size of induration or redness in non-TB subjects with lung disease | within 72h after injection | We measure the size of induration or redness at 24h, 48h, 72h after administered intradermally left arm (random injected ESAT6-CFP10 or PPD) |
| Immune response of right arm (random injected ESAT6-CFP10 or PPD) from the size of induration or redness in non-TB subjects with lung disease | within 72h after injection | We measure the size of induration or redness at 24h, 48h, 72h after administered intradermally right arm (random injected ESAT6-CFP10 or PPD) |
Secondary
| Measure | Time frame |
|---|---|
| Number of participants with Adverse Events | within 72h after injection two drug each participant |
Countries
China
Outcome results
None listed