Tuberculosis (TB)NCT07003581
Cardiometabolic Risk Factors Associated With Multidrug-Resistant Tuberculosis
An observational study of Tuberculosis (TB), run by B.P. Koirala Institute of Health Sciences at 1 site in Nepal.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tuberculosis (TB)
- How many people
- 183 participants
- Where
- 1 siteNepal
- Study dates
- 4 Sep 2024to 30 Jan 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cardiometabolic Risk Factors Associated With Multidrug-Resistant Tuberculosis: A Case-Control Study
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.
Read the detailed description
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
A hierarchical procedure will be used to match controls with cases using the following variables, in order of importance:
Sex
Same age ± 5 years
Measurements
The primary exposure variables will include five key cardiometabolic risk factors:
Alcohol use - defined as current or past habitual consumption of alcoholic beverages.
Tobacco use - current or past smoking or smokeless tobacco consumption.
Body Mass Index (BMI) - calculated from measured height and weight and categorized according to WHO standards: underweight (<18.5 kg/m²), normal (18.5-24.9 kg/m²), overweight (25.0-29.9 kg/m²), and obese (≥30 kg/m²).
Hypertension - based on prior diagnosis, current use of antihypertensive medications, or blood pressure ≥140/90 mmHg.
Diabetes Mellitus (DM) - identified by self-reported diagnosis, anti-diabetic treatment, or fasting blood glucose ≥126 mg/dL.
Participants will be grouped into two categories based on the presence of these risk factors:
At least one cardiometabolic risk factor
No cardiometabolic risk factors
Additional Background Variables
Additional covariates will include:
Sociodemographic Characteristics: Age, sex, ethnicity, place of residence (rural/urban), occupation, educational attainment, marital status, type of settlement (temporary/permanent), and household size.
TB Literacy: Participants' knowledge regarding tuberculosis will be evaluated using a structured questionnaire covering TB transmission, prevention methods, and treatment practices.
Disease-Specific Factors: These will include history of contact with a known TB case, prior TB diagnosis, number of TB episodes, history of TB treatment interruption (including interruptions ≥1 week), medication history, treatment outcomes from previous episodes (e.g., cured, failed), and presence of coexisting conditions such as HIV/AIDS.
Sample Size Determination and Recruitment The sample size will be calculated using Epi-Info 7.2 statistical software. The parameters will include a prevalence of previously treated TB among controls of 10.4%, an odds ratio for MDR-TB among previously treated patients of 2.8, a 1:2 case-to-control ratio, 90% power, and 95% confidence level.
To adjust for potential non-response, the initially calculated sample size of 146 will be increased by 10%, resulting in a total of 162 participants: 54 cases and 108 controls. All cases and controls who fulfill the inclusion criteria will be consecutively enrolled until the required sample size is achieved.
Sample size formula:
N = ((Z<sub>1-α/2</sub> + Z<sub>1-β</sub>)² × (p₀q₀ + p₁q₁)) / (p₁ - p₀)²
p₀ = likely proportion of previous treatment history among controls
q₀ = 1 - p₀
p₁ = likely proportion among cases
q₁ = 1 - p₁
α = significance level
1 - β = power of the test
Data Collection Tools and Study Procedures Data will be collected face-to-face using a structured, bilingual (English and Nepali), and pre-tested survey questionnaire adapted from existing literature. Patient recruitment will occur over a 16-week period, from 1st September 2024 to 31st December 2024. After obtaining written informed consent, each participant will be interviewed using a standardized questionnaire in their preferred language (English or Nepali). To minimize recall bias, a Nepali calendar will be used for referencing dates. Data will be collected using the KoboCollect app. All interviews will be conducted by trained medical officers.
Data Analysis Initially, the raw data will be entered into Microsoft Excel, where it will undergo cleaning and consistency checks. Descriptive statistics will be presented as means and standard deviations for continuous variables and frequencies and percentages for categorical variables. Multivariate logistic regression will be used to identify independent associations between cardiometabolic risk factors and MDR-TB, controlling for relevant background variables. Adjusted odds ratios (AORs) with 95% confidence intervals (CIs) will be reported. A p-value of less than 0.05 will be considered statistically significant. All statistical analyses will be performed using SPSS version 25 (IBM, Armonk, NY).
Ethical Considerations Ethical approval will be obtained from the Nepal Health Research Council. Permission will also be obtained from hospital administrations to approach participants for data collection (Protocol Registration No: 441_2024). Before data collection, the nature and purpose of the study will be explained to participants verbally, and written informed consent will be obtained. Participants' anonymity and confidentiality will be ensured throughout the study.
- Conditions
- Tuberculosis (TB)
- Keywords
- Tuberculosis, Multidrug resistant
- Medical subject headings
- 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 |
|---|---|---|
| Case | MDR-TB patient | |
| Control | Drug sensitive TB patient |
What is being measured
The primary outcome is the main question the study is designed to answer.
Multidrug-Resistant Tuberculosis (MDR-TB) status
This outcome is assessed retrospectively based on confirmed laboratory diagnosis at the DR-TB treatment centers.
Measured: At the time of study enrollment (cross-sectional capture of TB drug resistance status at diagnosis)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2025
- Study start4 Sep 2024
- Primary completion31 Dec 2024
- Study completion30 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tuberculosis (TB)Studies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 183 participants (actual)
Sponsor and investigators
- Lead sponsor
- B.P. Koirala Institute of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sishir Poudel, B.P. Koirala Institute of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07003581
- Sponsor's protocol ID
- 441_2024
- Status last verified
- Jun 2025
- First submitted
- 26 May 2025
- Last updated
- 26 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual Participant Data (IPD) will not be shared due to the sensitive and confidential nature of tuberculosis-related information. Tuberculosis remains a highly stigmatized condition in many communities, including in Nepal, and sharing participant-level data could potentially compromise patient privacy and confidentiality, even if de-identified
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiometabolic Risk Factors Associated With Multidrug-Resistant Tuberculosis: A Case-Control Study
- ClinicalTrials.gov ID
- NCT07003581
- Acronym / sponsor ID
- 441_2024
- Conditions
- Tuberculosis (TB)
- Keywords
- Tuberculosis, Multidrug resistant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 183 participants (actual)
- Lead sponsor
- B.P. Koirala Institute of Health SciencesUniversity, hospital or other
- Study start
- 4 Sep 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 30 Jan 2025 (actual)
- First posted
- 4 Jun 2025 (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.
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.
Detailed description
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
A hierarchical procedure will be used to match controls with cases using the following variables, in order of importance:
Sex
Same age ± 5 years
Measurements
The primary exposure variables will include five key cardiometabolic risk factors:
Alcohol use - defined as current or past habitual consumption of alcoholic beverages.
Tobacco use - current or past smoking or smokeless tobacco consumption.
Body Mass Index (BMI) - calculated from measured height and weight and categorized according to WHO standards: underweight (<18.5 kg/m²), normal (18.5-24.9 kg/m²), overweight (25.0-29.9 kg/m²), and obese (≥30 kg/m²).
Hypertension - based on prior diagnosis, current use of antihypertensive medications, or blood pressure ≥140/90 mmHg.
Diabetes Mellitus (DM) - identified by self-reported diagnosis, anti-diabetic treatment, or fasting blood glucose ≥126 mg/dL.
Participants will be grouped into two categories based on the presence of these risk factors:
At least one cardiometabolic risk factor
No cardiometabolic risk factors
Additional Background Variables
Additional covariates will include:
Sociodemographic Characteristics: Age, sex, ethnicity, place of residence (rural/urban), occupation, educational attainment, marital status, type of settlement (temporary/permanent), and household size.
TB Literacy: Participants' knowledge regarding tuberculosis will be evaluated using a structured questionnaire covering TB transmission, prevention methods, and treatment practices.
Disease-Specific Factors: These will include history of contact with a known TB case, prior TB diagnosis, number of TB episodes, history of TB treatment interruption (including interruptions ≥1 week), medication history, treatment outcomes from previous episodes (e.g., cured, failed), and presence of coexisting conditions such as HIV/AIDS.
Sample Size Determination and Recruitment The sample size will be calculated using Epi-Info 7.2 statistical software. The parameters will include a prevalence of previously treated TB among controls of 10.4%, an odds ratio for MDR-TB among previously treated patients of 2.8, a 1:2 case-to-control ratio, 90% power, and 95% confidence level.
To adjust for potential non-response, the initially calculated sample size of 146 will be increased by 10%, resulting in a total of 162 participants: 54 cases and 108 controls. All cases and controls who fulfill the inclusion criteria will be consecutively enrolled until the required sample size is achieved.
Sample size formula:
N = ((Z<sub>1-α/2</sub> + Z<sub>1-β</sub>)² × (p₀q₀ + p₁q₁)) / (p₁ - p₀)²
p₀ = likely proportion of previous treatment history among controls
q₀ = 1 - p₀
p₁ = likely proportion among cases
q₁ = 1 - p₁
α = significance level
1 - β = power of the test
Data Collection Tools and Study Procedures Data will be collected face-to-face using a structured, bilingual (English and Nepali), and pre-tested survey questionnaire adapted from existing literature. Patient recruitment will occur over a 16-week period, from 1st September 2024 to 31st December 2024. After obtaining written informed consent, each participant will be interviewed using a standardized questionnaire in their preferred language (English or Nepali). To minimize recall bias, a Nepali calendar will be used for referencing dates. Data will be collected using the KoboCollect app. All interviews will be conducted by trained medical officers.
Data Analysis Initially, the raw data will be entered into Microsoft Excel, where it will undergo cleaning and consistency checks. Descriptive statistics will be presented as means and standard deviations for continuous variables and frequencies and percentages for categorical variables. Multivariate logistic regression will be used to identify independent associations between cardiometabolic risk factors and MDR-TB, controlling for relevant background variables. Adjusted odds ratios (AORs) with 95% confidence intervals (CIs) will be reported. A p-value of less than 0.05 will be considered statistically significant. All statistical analyses will be performed using SPSS version 25 (IBM, Armonk, NY).
Ethical Considerations Ethical approval will be obtained from the Nepal Health Research Council. Permission will also be obtained from hospital administrations to approach participants for data collection (Protocol Registration No: 441_2024). Before data collection, the nature and purpose of the study will be explained to participants verbally, and written informed consent will be obtained. Participants' anonymity and confidentiality will be ensured throughout the study.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case | – | –MDR-TB patient |
| Control | – | –Drug sensitive TB patient |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
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
Multidrug-Resistant Tuberculosis (MDR-TB) status
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2025.
- Individual participant dataSharing planned: No. Individual Participant Data (IPD) will not be shared due to the sensitive and confidential nature of tuberculosis-related information. Tuberculosis remains a highly stigmatized condition in many communities, including in Nepal, and sharing participant-level data could potentially compromise patient privacy and confidentiality, even if de-identified
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tuberculosis (TB), run by B.P. Koirala Institute of Health Sciences at 1 site in Nepal.
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 5 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: finished, as of the sponsor's last update on 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nepal. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Multidrug-Resistant Tuberculosis (MDR-TB) status (time frame: At the time of study enrollment (cross-sectional capture of TB drug resistance status at diagnosis)). 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 26 Jun 2025.