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| Name | Class |
|---|---|
| Shenzhen Third People's Hospital | OTHER |
| Beijing Kangterike Statistical Technology Co., Ltd. | UNKNOWN |
| Wuhan Pulmonary Hospital | OTHER |
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A total of 60 TB patients aged 65 years and below who are randomly assigned to the experimental group and the control group. The experimental group is injected with BCG-PPD test drug once, and the control group is injected with BCG-PPD control drug once.Subjects undergoing physical examination, vital signs, blood routine, urine routine, blood biochemistry, electrocardiogram, chest X-ray, tuberculosis culture, tuberculosis smear, HIV antibody test and blood pregnancy(only women of childbearing age) during the screening period.Vital signs were checked before skin test, the injection site is photographed at 0min after skin test, and vital signs are checked at 30min after skin test.Vital signs examination, injection site photography and reaction measurement are performed 48h and 72h after skin test.Physical examination, vital signs, routine blood test, routine urine test, biochemical test, electrocardiogram and blood pregnancy test are performed again 7 days after skin test to evaluate the safety of BCG-PPD.
Prior to the commencement of the study, the Investigator/his authorized officer will contact the subject and/or guardian to enroll the candidate subjects and invite them to participate in the study.Subjects who are eligible for screening receive the drug number in the order they arrive at the random number allocation room.They have to undergoing physical examination, vital signs, blood routine, urine routine, blood biochemistry, electrocardiogram, chest X-ray, tuberculosis culture, tuberculosis smear, HIV antibody test and blood pregnancy(only women of childbearing age) during the screening period. Inverstigator absorb and inject 0.1ml drug into the upper and middle 1/3 of the left forearm by Mondo's method. The reaction of the injection site was checked and photographed at 0min, 48h and 72h after the skin test. Meanwhile, the transverse and longitudinal diameers of skin induration and redness were measured at 48h and 72h after the skin test.Vital signs are checked at 30min after skin test.Vital signs examination, injection site photography and reaction measurement are performed 48h and 72h after skin test.Physical examination, vital signs, routine blood test, routine urine test, biochemical test, electrocardiogram and blood pregnancy test are performed again 7 days after skin test.All AE occurred within 7 days after skin test were recorded by a diary card. AE related to the test drug should be followed up to the end of the event.Skin test of subjects aged 18-45 years shall be conducted first. After safety assessment, skin test of subjects aged 46-65 years old, 6-17 years old and under 6 years old shall be conducted successively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | 30 tuberculosis patient were randomly assigned to the experimental group and the control group. The experimental group was injected with BCG-PPD drug once, while the control group was injected with BCG-PPD drug once |
|
| control group | Other | 30 tuberculosis patient were randomly assigned to the experimental group and the control group. The experimental group was injected with BCG-PPD drug once, while the control group was injected with BCG-PPD drug once |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BCG-PPD | Drug | BCG-PPD was used for skin test in 30 TB patients, and BCG-PPD was marketed in other 30 TB patients (as control) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the incidence of all adverse event and results of laboratory tests | Record and evaluate the incidence of all adverse event within 7 days after injectionï¼›Record and evaluate abnormal incidence of blood routine, urine routine, blood biochemical and electrocardiogram indicators 7 days after injection | 7 days after injection |
| Evaluate the effectiveness of the product by measuring the size of the skin response | The transverse and longitudinal diameters (millimetre) of skin induration and redness, as well as local double circles, blisters, necrosis, and lymphangitis, were recorded at 48h and 72h after injection | Between 48 and 72 hours after injection |
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Inclusion Criteria:
Inclusion criteria for tuberculosis patients:
Inclusion criteria for patients with extrapulmonary tuberculosis:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shuihua Lu, Bachelor | Shenzhen Third People's Hospital | Principal Investigator |
| Hai Huang, Bachelor | Wuhan Pulmonary Hospital | Principal Investigator |
| Guan Liu, Master | Wuhan Pulmonary Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Third People's Hospital Of Shenzhen | Shenzhen | Guangdong | China |
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| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| ID | Term |
|---|---|
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
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| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |