Multidrug Resistant TuberculosisNCT04484129
MDR-TB Close Contacts Tracing in China (TCCT Study)
An observational study of Multidrug Resistant Tuberculosis, run by Huashan Hospital at 8 sites in China.
Trial summary
To investigate the incidence of etiologically confirmed or clinically diagnosed active tuberculosis in close contacts of MDR-TB patients. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Multidrug Resistant Tuberculosis
- How many people
- 500 participants
- Where
- 8 sitesChina
- Study dates
- 21 Jul 2020to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population enrolled in this study is close contact of patients with MDR-TB
Who may be able to join
- 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.
- 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.
Who cannot join
- 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.
Show all 13Show fewer
- The close contacts:
- 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.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
China8 sites
Guiyang Public Health Treatment Center
Guizhou, Guizhou
Cui Cai, 86+13885078936
Hangzhou Red Cross Hospital
Hangzhou, Zhejiang
Qingshan Cai, 86+13867429139, caiqs66@163.com
Jiangxi Public Health Center
Nanchang, Jiangxi
Xinya Yuan, 86+13870963101
Huashan Hospital of Fudan University
Shanghai, Shanghai Municipality, 200040
Wenhong Zhang, PhD,MD, +86 21 52889999 ext. 8123, zhangwenhong@fudan.edu.cn
Qiaoling Ruan
The Third People's Hospital of Shenzhen City
Shenzhen, Guangzhou
Guofang Deng, 86+13530027001, lalaliy@sina.com
Chest Hospitalof Xinjiang Uygur Autonomous Region of PRC
Ürümqi, Xinjiang
Wenlong Guan, 86+13899866660, 18999918582@189.cn
The Central Hospital of Wenzhou City
Wenzhou, Zhejiang
Xiangao Jiang, 86+13676788085
Henan Hospital of Infectious Diseases
Zhengzhou, Henan
Yu Chen, 86+15936200217
About this study
Official title: Multidrug Resistant Tuberculosis Close Contacts Tracing in China
To investigate the incidence of etiologically confirmed or clinically diagnosed active tuberculosis in close contacts of MDR-TB patients.
Read the 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.
- Conditions
- Multidrug Resistant Tuberculosis
- Keywords
- Multidrug Resistant Tuberculosis, latent tuberculosis, close contacts, transmission
- Medical subject headings
- Tuberculosis, Multidrug-Resistant, Latent Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 80 weeks after enter the group
Secondary outcomes (4)
Incidence of latent tuberculosis infection
Incidence of latent tuberculosis infection at enrollment
Measured: at enrollment
Risk factors associated with TB development
Risk factors associated with TB development among the close contact population
Measured: 80 weeks after enter the group
Compliance of follow-up
number of participants who complete the follow-up schedule
Measured: 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
Measured: 80 weeks after enter the group
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2020
- Study start21 Jul 2020 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multidrug Resistant TuberculosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wen-hong Zhang, Huashan Hospital
- Investigators
- Wenhong Zhang, PhD, Principal investigator, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04484129
- Sponsor's protocol ID
- KY2020-806
- Status last verified
- Jul 2020
- First submitted
- 20 Jul 2020
- Last updated
- 23 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multidrug Resistant Tuberculosis Close Contacts Tracing in China
- ClinicalTrials.gov ID
- NCT04484129
- Acronym / sponsor ID
- KY2020-806
- Conditions
- Multidrug Resistant Tuberculosis
- Keywords
- Multidrug Resistant Tuberculosis, latent tuberculosis, close contacts, transmission
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Study start
- 21 Jul 2020 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 23 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population enrolled in this study is close contact of patients with MDR-TB
Key inclusion criteria (4 listed)
- 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.
- 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.
Key exclusion criteria (13 listed)
- 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.
- The patient requests to withdraw from the visit;
- Misdiagnosis and error.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Confirmed cases of active tuberculosis
Time frame: 80 weeks after enter the group
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.
Clinical diagnosis of active tuberculosis
Time frame: 80 weeks after enter the group
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.
4 secondary outcomes
Incidence of latent tuberculosis infection
Time frame: at enrollment
Risk factors associated with TB development
Time frame: 80 weeks after enter the group
Compliance of follow-up
Time frame: 80 weeks after enter the group
Comparison the Mycobacteria tuberculosis strains between index patients and their contacts
Time frame: 80 weeks after enter the group
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wenhong Zhang, PhD principal investigator
Huashan Hospital
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multidrug Resistant Tuberculosis, run by Huashan Hospital at 8 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qiaoling Ruan, Dr. ((086)13661856002, ruan_qiao_ling@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Confirmed cases of active tuberculosis (time frame: 80 weeks after enter the group). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2020.