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

Fudan University

Status: Unknown

Conditions: Multidrug Resistant Tuberculosis

Study type: Observational

Funder types: Other

Identifiers

NCT04484129

KY2020-806

Details and patient eligibility

About

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

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

The index patient:

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.

Trial design

500 participants in 1 patient group

Close contacts of MDR-TB patients

Description:

Close contacts of MDR-TB who met the inclusion and exclusion criteria were enrolled. Routine follow-up is scheduled at week 8, 20, 32, and 80. During the visit, participants with suspected tuberculosis symptoms will have detailed clincial assessent, weight measurement, sputum smear, sputum culture and drug sensitivity examination, imaging examinations, etc. For patients diagnosed with TB, the trial ends. Proper treatment will be started. For all paricipants who are not diagnosed with tuebrculosis in previous follow-up, the last follow-up of this study is all "face-to-face" visits. Sputum smear, sputum culture and chest imaging screening will be performed when necessary to exclude the possibility of tuberculosis infection. In addition, If the participants has suspected TB symptoms or is diagnosed with TB in another hospital, the researchers can be contacted for follow-up at any time.