MDR-TB Close Contacts Tracing in China (TCCT Study)
Multidrug Resistant Tuberculosis Close Contacts Tracing in China
1 other identifier
observational
500
1 country
8
Brief Summary
To investigate the incidence of etiologically confirmed or clinically diagnosed active tuberculosis in close contacts of MDR-TB patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2020
Typical duration for all trials
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 20, 2020
CompletedStudy Start
First participant enrolled
July 21, 2020
CompletedFirst Posted
Study publicly available on registry
July 23, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedJuly 23, 2020
July 1, 2020
2.4 years
July 20, 2020
July 20, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (4)
Incidence of latent tuberculosis infection
at enrollment
Risk factors associated with TB development
80 weeks after enter the group
Compliance of follow-up
80 weeks after enter the group
Comparison the Mycobacteria tuberculosis strains between index patients and their contacts
80 weeks after enter the group
Study Arms (1)
Close contacts of MDR-TB patients
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.
Eligibility Criteria
The study population enrolled in this study is close contact of patients with MDR-TB
You may qualify if:
- 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.
You may not qualify if:
- 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:
- 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.
- 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;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Huashan Hospitallead
Study Sites (8)
The Third People's Hospital of Shenzhen City
Shenzhen, Guangzhou, China
Guiyang Public Health Treatment Center
Guizhou, Guizhou, China
Henan Hospital of Infectious Diseases
Zhengzhou, Henan, China
Jiangxi Public Health Center
Nanchang, Jiangxi, China
Huashan Hospital of Fudan University
Shanghai, Shanghai Municipality, 200040, China
Chest Hospitalof Xinjiang Uygur Autonomous Region of PRC
Ürümqi, Xinjiang, China
Hangzhou Red Cross Hospital
Hangzhou, Zhejiang, China
The Central Hospital of Wenzhou City
Wenzhou, Zhejiang, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wenhong Zhang, PhD
Huashan Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Division of Infectious Diseases
Study Record Dates
First Submitted
July 20, 2020
First Posted
July 23, 2020
Study Start
July 21, 2020
Primary Completion
December 31, 2022
Study Completion
December 31, 2022
Last Updated
July 23, 2020
Record last verified: 2020-07