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

• Conditions: Multidrug Resistant Tuberculosis

• Registration Number: NCT04484129
• Lead Sponsor: Huashan Hospital

Brief 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.

Study Timeline

• Status Verified: 2020-07
• Study First Submitted: 2020-07-20
• Study First Submitted QC: 2020-07-20
• Last Update Submitted: 2020-07-20
• Study Start: 2020-07-21
• Study First Posted: 2020-07-23
• Last Update Posted: 2020-07-23
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

1.18-70 years old; 2.Has smear-positive pulmonary tuberculosis with initial laboratory results with resistance to rifampicin confirmed by GeneXpert; 3.Have an identifiable address and stay in the area during the study period.

Exclusion Criteria

1. Combined extrapulmonary tuberculosis;
2. HIV antibody positive and AIDS patients;
3. Critically ill patients, and according to the judgment of the research physician, it is impossible to survive for more than 4 months.

Termination/termination criteria:

1. The patient requests to withdraw from the visit;
2. Misdiagnosis and error.

The close contacts:

Inclusion Criteria:

1. Willing to participate in trial treatment and follow-up and can give informed consent;
2. Willing to carry out HIV testing;
3. More than 6 hours of cohabitation per week in the 2 weeks prior to diagnosis of the index case.

Exclusion Criteria:

1. Patients with active tuberculosis confirmed clinically or etiologically;
2. Mental illness and severe neurosis;
3. The researchers determined that there were any ineligible conditions.

Termination/termination criteria:

1. The patient requests to withdraw from the visit;
2. Find a violation of inclusion or exclusion criteria during treatment.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Confirmed cases of active tuberculosis	80 weeks after enter the group	Mycobacterium tuberculosis was indicated to be positive by etiology, and the positive ones were confirmed by molecular identification. A false positive may be determined if the investigator determines that the etiological diagnosis is inconsistent with the patient's clinical condition, or that the patient's symptoms, signs, or influence of the medical diagnosis has not responded to treatment.
Clinical diagnosis of active tuberculosis	80 weeks after enter the group	History, signs, imaging studies (mainly chest CT), or other diagnostic methods suggest objective evidence (cough, fever, night sweats, wasting, hemoptysis) for the diagnosis of tuberculosis, rather than other diseases.

Secondary Outcome Measures

Name	Time	Method
Compliance of follow-up	80 weeks after enter the group	number of participants who complete the follow-up schedule
Comparison the Mycobacteria tuberculosis strains between index patients and their contacts	80 weeks after enter the group	All Mycobacteria tuberculosis strains from index patients ans close contacts will be analyzed to explore the transmission pattern
Incidence of latent tuberculosis infection	at enrollment	Incidence of latent tuberculosis infection at enrollment
Risk factors associated with TB development	80 weeks after enter the group	Risk factors associated with TB development among the close contact population

Trial Locations

Locations (8)

Huashan Hospital of Fudan University; 🇨🇳 Shanghai, Shanghai, China

The Central Hospital of Wenzhou City; 🇨🇳 Wenzhou, Zhejiang, China

Guiyang Public Health Treatment Center; 🇨🇳 Guizhou, Guizhou, China

Henan Hospital of Infectious Diseases; 🇨🇳 Zhengzhou, Henan, China

Jiangxi Public Health Center; 🇨🇳 Nanchang, Jiangxi, China

Chest Hospitalof Xinjiang Uygur Autonomous Region of PRC; 🇨🇳 Ürümqi, Xinjiang, China

The Third People's Hospital of Shenzhen City; 🇨🇳 Shenzhen, Guangzhou, China

Hangzhou Red Cross Hospital; 🇨🇳 Hangzhou, Zhejiang, China