Phase I Clinical Protocol for Pre-evaluation of the Safety of BCG-PPD in Tuberculosis Patients

NCT ID: NCT04538911

Last Updated: 2024-12-11

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-02
• Study Completion Date: 2025-12-31

Brief Summary

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.

Detailed Description

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.

Conditions

Tuberculosis

Keywords

diagnosis of tuberculosis; epidemiological investigation of tuberculosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: QUADRUPLE

Study Groups

Experimental group

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

Group Type: EXPERIMENTAL

BCG-PPD

Intervention Type: DRUG

BCG-PPD was used for skin test in 30 TB patients, and BCG-PPD was marketed in other 30 TB patients (as control)

control group

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

Group Type: OTHER

BCG-PPD

Intervention Type: DRUG

BCG-PPD was used for skin test in 30 TB patients, and BCG-PPD was marketed in other 30 TB patients (as control)

Interventions

BCG-PPD

BCG-PPD was used for skin test in 30 TB patients, and BCG-PPD was marketed in other 30 TB patients (as control)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Subjects aged 15 ~ 65 years (including 15 and 65 years old) who are clinically diagnosed or diagnosed with tuberculosis.

2. Subjects under the age of 15 (excluding those under the age of 15) who are clinically diagnosed or diagnosed with tuberculosis.

3. I (and/or my guardian) agree to participate in the study and sign the informed consent.

4. I (and/or guardian) can comply with the requirements of the clinical trial protocol to participate in the follow-up.

1. The patient was diagnosed with extrapulmonary tuberculosis by epidemiology, clinical manifestations, imaging examination, etiology examination, pathology examination and other auxiliary examinations, and the tuberculosis focus involved other parts of the lung.Combined with the characteristics of this clinical study and field implementation, the inclusion of patients with extrapulmonary tuberculosis should meet the "chemotherapy intensification period not completed".

2. I (and/or my guardian) agree to participate in the study and sign the informed consent.

3. I (and/or guardian) can comply with the requirements of the clinical trial protocol to participate in the follow-up.

Exclusion Criteria

1. Suffering from acute infectious diseases (such as measles, pertussis, influenza, pneumonia, etc.), acute ophthalmic membranitis, acute otitis media, extensive skin diseases and allergic constitution(A history of allergy to two or more drugs or foods, or a known allergy and scar constitution to this drug component).

2. People have any serious disease, such as: tumor, progressive atherosclerosis or diabetes with complications, chronic obstructive pulmonary disease requiring oxygen therapy, acute or progressive liver or kidney disease, congestive heart failure, etc.

3. Convulsion, epilepsy, history of mental illness and/or family history of mental illness.

4. Patients with known or suspected (or high-risk) immune function impairment or abnormality,For example, patients receiving immunosuppressive or immunobooster therapy, patients receiving glucocorticoids, immunoglobulin preparations or blood products or plasma extracts outside the gastrointestinal tract within 3 months, human immunodeficiency virus infection or related diseases.

5. The test results of human immunodeficiency virus (HIV) antibody are positive.

6. Before enrollment, the interval between inoculation of live attenuated vaccine is less than 28 days, and the interval between inoculation of other vaccines is less than 14 days.

7. In the acute stage of disease or acute onset of chronic disease (3 days before skin test).

8. People are participating in or has participated in any other clinical investigator within 3 months prior to this clinical study.

9. Pregnant or lactating women, or planning to become pregnant during the study period.

10. A clear history of hypertension.

11. Suspected or confirmed drug abuse or alcohol abuse.

12. persons with upper limb disabilities.

13. Infants (under one year of age) whose birth weight is less than 2.5kg, or premature or refractory infants.

14. Infants (under 1 year of age) suffering from neonatal respiratory distress syndrome, pathological jaundice, congenital malformations, developmental disorders and congenital diseases.

15. The investigator believes that there are any conditions such as poor compliance that may affect the evaluation of the trial.

• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shenzhen Third People's Hospital

OTHER

Sponsor Role: collaborator

Beijing Kangterike Statistical Technology Co., Ltd.

UNKNOWN

Sponsor Role: collaborator

Wuhan Pulmonary Hospital

OTHER

Sponsor Role: collaborator

Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shuihua Lu, Bachelor

Role: PRINCIPAL_INVESTIGATOR

Shenzhen Third People's Hospital

Hai Huang, Bachelor

Role: PRINCIPAL_INVESTIGATOR

Wuhan Pulmonary Hospital

Guan Liu, Master

Role: PRINCIPAL_INVESTIGATOR

Wuhan Pulmonary Hospital

Locations

The Third People's Hospital Of Shenzhen

Shenzhen, Guangdong, China

Countries

China

Other Identifiers

LKM-2020-PPD02

Identifier Type: -

Identifier Source: org_study_id