NCT07003581Completed
Cardiometabolic Risk Factors Associated With Multidrug-Resistant Tuberculosis
Cardiometabolic Risk Factors Associated With Multidrug-Resistant Tuberculosis: A Case-Control Study
Source: ClinicalTrials.gov · Last updated 26 Jun 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 183 (actual)
- First submitted
- 26 May 2025
- Start date
- 4 Sept 2024
- Primary completion date
- 31 Dec 2024
- Lead sponsor
- B.P. Koirala Institute of Health Sciences
- Diseases
- Tuberculosis
- NCT number
- NCT07003581
What you commit to
- Study type: Observational
- Participants enrolled: 183
- From 4 Sept 2024 to the primary completion date, 31 Dec 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patients with severe illness or comorbidities that preclude participation in an interview (e.g., unconscious, severely mentally ill).
Other
- Patients with extrapulmonary TB only, without confirmed pulmonary involvement.
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mustang Hospital Coordinator of this site? Confirm its status | Jomsom | Nepal | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.