Cardiometabolic Risk Factors Associated With Multidrug-Resistant Tuberculosis

NCT07003581 | Completed DMC

• 1 other identifier: 441_2024
• Study Type: observational
• Target: 183
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Tuberculosis (TB)

Keywords

Tuberculosis; Multidrug resistant

Outcome Measures

Primary Outcomes (1)

• Multidrug-Resistant Tuberculosis (MDR-TB) status

  This outcome is assessed retrospectively based on confirmed laboratory diagnosis at the DR-TB treatment centers.

  At the time of study enrollment (cross-sectional capture of TB drug resistance status at diagnosis)

Study Arms (2)

Case

MDR-TB patient

Control

Drug sensitive TB patient

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will include patients undergoing treatment at drug-resistant tuberculosis (DR-TB) treatment centers in Gandaki Province. Cases will consist of patients diagnosed with MDR-TB while controls will be patients with drug-susceptible (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 drug-susceptible TB controls based on key demographic variables such as age and gender.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• B.P. Koirala Institute of Health Sciences: lead

Study Sites (1)

Mustang Hospital

Jomsom, 33100, Nepal

Location

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: May 26, 2025
• First Posted: June 4, 2025
• Study Start: September 4, 2024
• Primary Completion: December 31, 2024
• Study Completion: January 30, 2025
• Last Updated: June 26, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

NE (1)