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

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

Detailed Description
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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.

Official Title
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Multidrug Resistant Tuberculosis Close Contacts Tracing in China

Conditions
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Multidrug Resistant Tuberculosis

Participation Criteria
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Eligibility Criteria
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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: Combined extrapulmonary tuberculosis; HIV antibody positive and AIDS patients; 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: The patient requests to withdraw from the visit; Misdiagnosis and error. The close contacts: Inclusion Criteria: Willing to participate in trial treatment and follow-up and can give informed consent; Willing to carry out HIV testing; More than 6 hours of cohabitation per week in the 2 weeks prior to diagnosis of the index case. Exclusion Criteria: Patients with active tuberculosis confirmed clinically or etiologically; Mental illness and severe neurosis; The researchers determined that there were any ineligible conditions. Termination/termination criteria: The patient requests to withdraw from the visit; Find a violation of inclusion or exclusion criteria during treatment.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Close contacts of MDR-TB patients<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Confirmed cases of active tuberculosis | 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. | 80 weeks after enter the group | 
| Clinical diagnosis of active tuberculosis | 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. | 80 weeks after enter the group | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multidrug Resistant Tuberculosis, latent tuberculosis, close contacts, transmission