Multidrug Resistant Tuberculosis
Conditions
Keywords
Multidrug Resistant Tuberculosis, latent tuberculosis, close contacts, transmission
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.
Interventions
None listed
Sponsors
Huashan Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Confirmed cases of active tuberculosis | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of latent tuberculosis infection | at enrollment | Incidence of latent tuberculosis infection at enrollment |
| Risk factors associated with TB development | 80 weeks after enter the group | Risk factors associated with TB development among the close contact population |
| Compliance of follow-up | 80 weeks after enter the group | number of participants who complete the follow-up schedule |
| Comparison the Mycobacteria tuberculosis strains between index patients and their contacts | 80 weeks after enter the group | All Mycobacteria tuberculosis strains from index patients ans close contacts will be analyzed to explore the transmission pattern |
Countries
China
Contacts
Primary ContactQiaoling Ruan, Dr.
Outcome results
None listed