NCT02623556

Clinical Study of Recombinant Mycobacterium Tuberculosis ESAT6-CFP10 Allergen

For Tuberculosis (TB) Clinical Auxiliary Diagnosis of Recombinant Mycobacterium Tuberculosis Allergen ESAT6 - CFP10 Dose of Certain Phase III Clinical Research

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,090 (estimated)
• Sponsor: Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Tuberculosis

Interventions

Type	Name	Description
BIOLOGICAL	ESAT6-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.
BIOLOGICAL	ESAT6-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.

Timeline

• Start date: 2015-12-01
• Primary completion: 2018-03-01
• Completion: 2018-03-01
• First posted: 2015-12-07
• Last updated: 2018-04-12

Locations

2 sites across 1 country: China