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

Multidrug Resistant Tuberculosis Clinical Trial

Official title:

Multidrug Resistant Tuberculosis Close Contacts Tracing in China

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04484129
• Other study ID #: KY2020-806
• Status: Not yet recruiting
• Start date: July 21, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: July 2020
• Source: Huashan Hospital
• Contact: Qiaoling Ruan, Dr.
• Phone: (086)13661856002
• Email: ruan_qiao_ling[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Multidrug Resistant Tuberculosis
• Tuberculosis
• Tuberculosis, Multidrug-Resistant

Locations

Country	Name	City	State
China	Guiyang Public Health Treatment Center	Guizhou	Guizhou
China	Hangzhou Red Cross Hospital	Hangzhou	Zhejiang
China	Jiangxi Public Health Center	Nanchang	Jiangxi
China	Huashan Hospital of Fudan University	Shanghai	Shanghai
China	The Third People's Hospital of Shenzhen City	Shenzhen	Guangzhou
China	Chest Hospitalof Xinjiang Uygur Autonomous Region of PRC	Ürümqi	Xinjiang
China	The Central Hospital of Wenzhou City	Wenzhou	Zhejiang
China	Henan Hospital of Infectious Diseases	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Huashan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Incidence of latent tuberculosis infection	Incidence of latent tuberculosis infection at enrollment	at enrollment
Secondary	Risk factors associated with TB development	Risk factors associated with TB development among the close contact population	80 weeks after enter the group
Secondary	Compliance of follow-up	number of participants who complete the follow-up schedule	80 weeks after enter the group
Secondary	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