NCT04484129

MDR-TB Close Contacts Tracing in China (TCCT Study)

Multidrug Resistant Tuberculosis Close Contacts Tracing in China

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: Huashan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

To investigate the incidence of etiologically confirmed or clinically diagnosed active tuberculosis in close contacts of MDR-TB patients.

Detailed description

This study is a prospective observational cohort study. MDR-TB patients from multi-centers in China were continuously evaluated one by one, their close contacts were screened for elibgility. All subjects were followed for the same length of time: 80 weeks after enrollment. The symptoms and signs of tuberculosis were followed up to monitor the occurrence of tuberculosis. The primary objective is to investigate the incidence of etiologically confirmed or clinically diagnosed active TUBERCULOSIS in close contacts of MDR-TB patients. The secondary objective is to assess latent TB infection rates in close contacts of MDR-TB patients; evaluate the high risk factors of TUBERCULOSIS in close contact population; assess the loss rate of close contacts within 80 weeks; assess the 80-week mortality rate among close contacts; isolate the mycobacterium tuberculosis from all patients with active tuberculosis and analyze drug resistance to evaluate the homology and drug-resistant transmission pattern of Mycobacterium tuberculosis.

Conditions

• Multidrug Resistant Tuberculosis

Timeline

• Start date: 2020-07-21
• Primary completion: 2022-12-31
• Completion: 2022-12-31
• First posted: 2020-07-23
• Last updated: 2020-07-23

Locations

8 sites across 1 country: China