Cardiometabolic Risk Factors Associated With Multidrug-Resistant Tuberculosis: A Case-Control Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 183
- 试验地点
- 1
- 主要终点
- Multidrug-Resistant Tuberculosis (MDR-TB) status
研究概览
简要总结
Background: MDR-TB (Multidrug Resistant tuberculosis) remains a major public health concern, especially in high-burden countries like Nepal. While individual risk factors are known, the cumulative impact of cardiometabolic on MDR-TB is not well understood.
Methods and Findings: A health-facility-based, age- and sex-matched 1:2 case-control study will be conducted at DR-TB (Drug Resistant Tuberculosis) treatment centers in Gandaki Province, Nepal. MDR-TB patients (cases) and DS-TB patients (controls) will be enrolled. Cases will be defined as adults (≥18 years) with confirmed MDR-TB; controls will be adults with sputum-positive DS-TB (Drug Sensitive Tuberculosis). Data on sociodemographics, cardiometabolic risk factors (alcohol, tobacco, BMI, hypertension, diabetes), TB literacy, and treatment history will be collected using a structured, pretested questionnaire by trained medical officers. Data will be analyzed using SPSS v25. Binary logistic regression will be used to assess associations between risk factors and MDR-TB. Ethical approval will be obtained from the NHRC, and written informed consent will be obtained from all participants.
详细描述
Materials and Methods Study Design and Setting A health-facility-based, age- and sex-matched 1:2 case-control study will be conducted from September 2024 to February 2025 at DR-TB treatment centers in Gandaki Province, Nepal. These centers will include the Tuberculosis Treatment Center (Pokhara), Madhyabindu District Hospital (Nawalpur), and Dhawalagiri Hospital (Baglung). These centers are specialized facilities providing comprehensive TB care and treatment services, including for drug-resistant tuberculosis (DR-TB). They serve diverse populations from urban, semi-urban, and rural areas, ensuring a representative sample of the region's TB patients. The selection of these centers will allow for broad geographical representation and access to a large number of DR-TB patients.
Cases and Controls Selection The study will include patients undergoing treatment at DR-TB treatment centers in Gandaki Province. Cases will consist of patients diagnosed with MDR-TB, while controls will be patients with drug-susceptible TB (DS-TB) who are also receiving treatment at the same centers. To ensure comparability, each MDR-TB case will be matched with one or more DS-TB controls based on key demographic variables such as age and gender.
Cases A participant will be eligible to be included as a case if they are aged 18 years or older and diagnosed with MDR-TB (resistant to at least rifampicin and isoniazid) for the first time at the time of enrollment.
Controls A participant will be eligible to be included as a control if they are aged 18 years or older, diagnosed with sputum smear-positive DS-TB for the first time, and have received at least two weeks of anti-TB treatment.
Matching Criteria
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 years or older.
- •Diagnosed with multidrug-resistant TB (MDR-TB) (resistant to at least isoniazid and rifampicin), confirmed by drug susceptibility testing or GeneXpert or Drug Sensitive TB
- •Newly diagnosed with MDR-TB (i.e., not previously treated for MDR-TB) or DS-TB.
- •Able and willing to provide written informed consent.
排除标准
- •Patients with extrapulmonary TB only, without confirmed pulmonary involvement.
- •Patients with severe illness or comorbidities that preclude participation in an interview (e.g., unconscious, severely mentally ill).
- •Pregnant women (if cardiometabolic variables like BMI or BP may be physiologically altered).
- •Participants who refuse or are unable to provide informed consent.
- •Patients who have incomplete or missing data on key exposure or outcome variables.
结局指标
主要结局
Multidrug-Resistant Tuberculosis (MDR-TB) status
时间窗: At the time of study enrollment (cross-sectional capture of TB drug resistance status at diagnosis)
This outcome is assessed retrospectively based on confirmed laboratory diagnosis at the DR-TB treatment centers.
次要结局
未报告次要终点
研究者
Sishir Poudel
Doctor
B.P. Koirala Institute of Health Sciences