Phase I Clinical Protocol for Pre-evaluation of the Safety of BCG-PPD in Tuberculosis Patients
Status:
Not yet recruiting
Trial end date:
2021-12-01
Target enrollment:
Participant gender:
Summary
A total of 80 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.