Clinical trial NCT04484129: MDR-TB Close Contacts Tracing in China (TCCT Study)
Official title: Multidrug Resistant Tuberculosis Close Contacts Tracing in China
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Multidrug Resistant Tuberculosis
Keywords: Multidrug Resistant Tuberculosis
latent tuberculosis
close contacts
transmission
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
First posted: 2020-07-23
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population enrolled in this study is close contact of patients with MDR-TB

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.

Eligibility 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.

Primary outcomes:
measure: Confirmed cases of active tuberculosis
timeFrame: 80 weeks after enter the group
measure: Clinical diagnosis of active tuberculosis
timeFrame: 80 weeks after enter the group
Secondary outcomes:
measure: Incidence of latent tuberculosis infection
timeFrame: at enrollment
measure: Risk factors associated with TB development
timeFrame: 80 weeks after enter the group
measure: Compliance of follow-up
timeFrame: 80 weeks after enter the group
measure: Comparison the Mycobacteria tuberculosis strains between index patients and their contacts
timeFrame: 80 weeks after enter the group
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: The Third People's Hospital of Shenzhen City
state: Guangzhou
city: Guizhou
country: China
facility: Guiyang Public Health Treatment Center
state: Guizhou
city: Zhengzhou
country: China
facility: Henan Hospital of Infectious Diseases
state: Henan
city: Nanchang
country: China
facility: Jiangxi Public Health Center
state: Jiangxi
city: Shanghai
country: China
facility: Huashan Hospital of Fudan University
state: Shanghai
city: Ürümqi
country: China
facility: Chest Hospitalof Xinjiang Uygur Autonomous Region of PRC
state: Xinjiang
city: Hangzhou
country: China
facility: Hangzhou Red Cross Hospital
state: Zhejiang
city: Wenzhou
country: China
facility: The Central Hospital of Wenzhou City
state: Zhejiang
Study officials:
affiliation: Huashan Hospital
name: Wenhong Zhang, PhD
role: PRINCIPAL_INVESTIGATOR
References: