Ignite Creation Date:
2024-05-06 @ 7:05 PM
Last Modification Date:
2024-10-26 @ 3:00 PM
Study NCT ID:
NCT05899179
Status:
RECRUITING
Last Update Posted:
2024-06-25
First Post:
2023-04-11
Brief Title:
Clinical Study of Recombinant Mycobacterium Tuberculosis Fusion Protein for 65-year-olds and Above
Sponsor:
Anhui Zhifei Longcom Biologic Pharmacy Co Ltd
Organization:
Anhui Zhifei Longcom Biologic Pharmacy Co Ltd
Study Overview
Official Title:
A Multicenter Randomized Double-blind Controlled Phase Ⅲ Trial of Recombinant Mycobacterium Tuberculosis Fusion Protein EC for the Diagnosis of Mycobacterium Tuberculosis Infection in 65-year-olds and Above
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A multicenter randomized blind controlled trial design was used to select 240 tuberculosis TB patients 120 non-tuberculous community population with other lung diseases and 420 healthy community population without other lung diseases who met the inclusion criteria of this study Blood supply specific gamma-interferon T-SPOT detection was performed first Then EC and Purified Protein derivation of tuberculin TB-PPD skin tests were performed on both arms and the recorded results were observed The first 24 cases of TB patients the first 12 cases of non-tuberculous community population with other lung diseases and the first 42 cases of healthy community population without other lung diseases were included in the trial subgroup Physical examination blood routine urine routine liver and kidney function and electrocardiogram tests were required before and 7 days after skin test after study number assignment
Detailed Description:
A multicenter randomized blind controlled trial design was adopted in this study Subjects were enrolled in this clinical study after being qualified by physical examination vital signs detection body temperature blood pressure pulse and respiration chest imaging DRCT examination mycobacterium tuberculosis etiology examination HIV antibody detection fasting blood glucose detection etc
A total of 240 TB patients 120 non-tuberculous community people with other lung diseases and 420 healthy community people without other lung diseases were selected for inclusion in this study Blood samples were collected for specific gamma-interferon T-SPOT detection and then EC and TB-PPD in the same double arm skin test were used to observe and record the results
The first 24 cases of TB patients the first 12 cases of non-tuberculous community population with other lung diseases and the first 42 cases of healthy community population without other lung diseases were included in the trial subgroup Physical examination blood routine urine routine liver and kidney function and electrocardiogram tests were required before and 7 days after skin test after study number assignment
Vital signs body temperature blood pressure pulse and respiration were measured 30min and 24h after skin test and body temperature was measured 48h and 72h after skin test The skin reaction at the injection site was observed at 0min 24h 48h and 72h after skin test
A total of 240 TB patients 120 non-tuberculous community people with other lung diseases and 420 healthy community people without other lung diseases were selected for inclusion in this study Blood samples were collected for specific gamma-interferon T-SPOT detection and then EC and TB-PPD in the same double arm skin test were used to observe and record the results
The first 24 cases of TB patients the first 12 cases of non-tuberculous community population with other lung diseases and the first 42 cases of healthy community population without other lung diseases were included in the trial subgroup Physical examination blood routine urine routine liver and kidney function and electrocardiogram tests were required before and 7 days after skin test after study number assignment
Vital signs body temperature blood pressure pulse and respiration were measured 30min and 24h after skin test and body temperature was measured 48h and 72h after skin test The skin reaction at the injection site was observed at 0min 24h 48h and 72h after skin test
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None