Tuberculosis, PulmonaryNCT06526221
Evaluating Urine Isoniazid Testing to Detect Nonadherence to Tuberculosis Medications in India
A study testing Urine isoniazid testing (IsoScreen test) in people with Tuberculosis, Pulmonary and Medication Adherence, run by Tufts University at 2 sites in India.
Trial summary
Tuberculosis (TB) is the leading infectious cause of death globally. India has the largest TB epidemic, accounting for one-quarter of cases and one-third of TB deaths worldwide. Nonadherence to medications is a central challenge in TB care leading to increased death, disease recurrence, and drug resistance. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tuberculosis, Pulmonary, Medication Adherence
- What is being tested?
- Urine isoniazid testing (IsoScreen test)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 900 participants
- Where
- 2 sitesIndia
- Study dates
- 7 Apr 2026to 1 Apr 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- 18+ years of age,
- presumed or confirmed drug-susceptible pulmonary TB (with or without a previous TB history), and
- taking an isoniazid-containing TB regimen.
Who cannot join
- inability to provide informed consent, or
- drug-resistant TB diagnosis or switch to another non-isoniazid-containing regimen (Note that this second exclusion criteria may result in retrospective exclusion from the study).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
India2 sites
ICMR-National Institute for Research in Tuberculosis (ICMR-NIRT)
Chennai, Tamil Nadu
ICMR-National Institute for Research in Tuberculosis (ICMR-NIRT)
Thanjavur, Tamil Nadu
About this study
Official title: Evaluating Urine Isoniazid Testing for Tuberculosis Disease in India to Detect Medication Nonadherence and Improve Treatment Outcomes
Tuberculosis (TB) is the leading infectious cause of death globally. India has the largest TB epidemic, accounting for one-quarter of cases and one-third of TB deaths worldwide. Nonadherence to medications is a central challenge in TB care leading to increased death, disease recurrence, and drug resistance. Despite its importance, detecting nonadherence in routine care is challenging, as current measurement approaches are inaccurate, not person-centered, or ineffective at improving outcomes. Early and accurate detection of nonadherence may serve as an entry point for differentiated care, in which people with TB at risk for poor outcomes can be given intensified interventions. Urine isoniazid testing is a validated, low-cost, point-of-care, and direct adherence measure that may be predictive of TB outcomes and therefore serve as an ideal triage test to enable differentiated care. However, to integrate urine testing into routine care, research is needed to: (1) understand how the test performs at scheduled clinic visits, (2) gain a rich understanding of root causes of nonadherence to better leverage urine test results, and (3) identify barriers and facilitators to implementation. In this study, the investigators propose conducting a 900 participant prospective cohort study with translational research involving clinical, behavioral, and implementation science to facilitate integration of urine isoniazid testing into India's national TB program. The investigators' central hypothesis is that urine testing can be integrated into routine care to facilitate early and accurate identification of people with TB who are likely to suffer poor outcomes, including death and TB recurrence. In Aim 1, the investigators will assess the accuracy of urine test results assessed at scheduled clinic visits in comparison to those assessed at unannounced home visits. In Aim 2, the investigators will assess the relationship between nonadherence detected by urine testing and subsequent unfavorable TB outcomes of death, loss to follow-up, treatment failure, and post-treatment TB recurrence.. This study proposal aims to develop an innovative but pragmatic strategy for early identification of TB medication nonadherence that is feasible in low- and middle-income countries with a high TB burden.
Read the detailed description
Tuberculosis (TB) is the leading infectious cause of death globally. India has the largest TB epidemic, accounting for one-quarter of cases and one-third of global TB deaths. Nonadherence to TB medications is associated with increased death, TB recurrence, and drug resistance. Specifically, missing >10% of doses is associated with six times greater risk of poor TB outcomes.2 The association between nonadherence to TB medications and emergence of drug resistance is one of the most concerning from a public health perspective. For example, one study found that nonadherence to TB therapy was associated with independent elevated risk of acquiring drug resistance (adjusted odds ratio 19.7, 95%CI 1.7-234). Another study found that, among people being treated for multidrug-resistant (MDR) TB, each additional month in which a patient failed to take 80% of their prescribed medication doses was associated with elevated risk of developing extensively drug-resistant (XDR) TB (adjusted hazard ratio 1.2, 95% CI 1.01-1.4).
Despite its importance, detecting nonadherence in routine care is challenging, especially as TB programs in low- and middle-income countries (LMICs) have moved away from directly observed therapy. Our research shows indirect measures-e.g., cellphone-based technology, pill counts, and patient-reported measures-miss detecting >30% of people with TB who are nonadherent by urine isoniazid testing.
Urine isoniazid testing is a low-cost, validated, direct point-of-care adherence measure that is predictive of TB outcomes. In a 650-participant cohort study in India, one unannounced home visit was conducted for each participant during TB therapy to conduct urine testing. That study found: (1) nonadherence was common by urine testing, with 18% of participants having missed more than 1 dose, and (2) negative urine test results were associated with 3.9 increased odds of death and 3.8 increased odds of loss to follow-up from treatment.
While urine testing has benefits, further research is needed to evaluate its uses under TB programs setting First, urine testing may perform differently in clinic as compared to unannounced home visits, as people with TB may modify adherence behavior in anticipation of scheduled clinic visits. Research is needed to understand how well testing at clinic visits represents adherence and predicts TB outcomes. Second, research is needed to understand reasons for nonadherence (i.e., negative urine test results) to inform personalized interventions for differentiated care. Third, implementation science research is needed to evaluate the use of urine testing in routine care in a manner that could lead to sustained use and impact.
The investigators propose conducting translational research involving clinical, behavioural, and implementation science to evaluate the use of urine isoniazid testing in the TB program. The investigators' central hypothesis is that urine testing could be useful within the routine care to facilitate early and accurate identification of people with TB who are likely to suffer poor outcomes, including death and TB recurrence. If this hypothesis is correct, the urine assay could serve as a triage test for developing differentiated care strategies, in which people at risk for poor outcomes are identified early and given intensified care
The investigators have the following specific aims:
Aim 1. To assess the agreement between urine test results collected at prescheduled clinic in comparison to unannounced home visits.
Summary of this aim: The investigators will enroll a cohort of 900 people starting 6-month drug-susceptible TB therapy. For each participant, to enable comparison of clinic and home samples, the investigators will conduct 1 urine test at a scheduled clinic visit and 1 urine test at an unannounced home visit during each of the intensive (first 2 months), early continuation (second 2 months), and late continuation (last 2 months) treatment phases.
Aim 2. To assess the relationship between nonadherence by urine testing and subsequent TB outcomes.
Summary of this aim: The investigators will follow the Aim 1 cohort participants through the completion of TB treatment (which usually takes 6 months) and then for 12 months after treatment and assess the following unfavorable outcomes: death, treatment failure, loss to follow-up, and TB recurrence. The investigators will assess the association between nonadherence by urine testing (separately for clinic and home samples) and the composite of these unfavorable outcomes (primary outcome) and with each unfavorable outcome individually (secondary outcomes).
- Conditions
- Tuberculosis, Pulmonary, Medication Adherence
- Being tested
- Urine isoniazid testing (IsoScreen test)
- Medical subject headings
- Tuberculosis, Pulmonary, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urine isoniazid testing (IsoScreen test)Diagnostic test
Developed by Arkansas' Public Health Service in the 1970s, this test detects metabolites of isoniazid, a drug present in drug-susceptible TB regimens. IsoScreen (GFC Diagnostics, UK) is a commercial version of the Arkansas method with reagents enclosed in a plastic vial, into which 2mL of urine can be injected with a syringe. If the urine contains isoniazid, reagents turn purple/blue (suggesting a dose was taken in the last 24 hours or appropriate adherence) or green (suggesting a dose was taken 24-48 hours before or one missed dose). A yellow result (no color change) suggests medication has not been taken for >48 hours (two or more missed doses).
| Study group | Role | What they receive |
|---|---|---|
| Urine isoniazid testing (intervention arm) | Experimental | This is the only study group/arm in this study. Participants in this study arm will receive urine isoniazid testing using the IsoScreen test in the TB clinic at monthly clinical and medication refill visits at month 1, 2, 3, 4, and 5 (5 times total). The will also undergo urine isoniazid testing using the IsoScreen test at home visits after months 1, 3, and 5 of treatment (3 times total). Receives: Diagnostic Test: Urine isoniazid testing (IsoScreen test) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of participants experiencing a composite unfavorable tuberculosis treatment outcome
The primary outcome will comprise the composite of: (1) loss to follow-up during treatment, (2) treatment failure, (3) death during the on-treatment or post-treatment period, and (4) TB recurrence. This will be reported as the number and proportion of participants experiencing one of the unfavorable outcomes, among all participants enrolled in the cohort study.
Measured: This outcome will be assessed during the course of TB treatment (usually about 6 months) and for the 12 months after TB treatment completion.
Secondary outcomes (4)
The proportion of participants lost to follow-up during tuberculosis treatment
This outcome will be defined as treatment interruption or being unable to contact a participant for >4 weeks. This will be reported as the number and proportion of participants experiencing loss to follow-up, among all participants enrolled in the cohort study.
Measured: This outcome will be assessed during the course of TB treatment (usually about 6 months).
The proportion of participants experiencing treatment failure (i.e., failure of tuberculosis treatment)
A participant (person with TB) whose sputum smear or culture is positive at month 5 or later during treatment. This will be reported as the number and proportion of all participants experiencing treatment failure, among all participants enrolled in the cohort study.
Measured: This outcome will be assessed during the course of TB treatment (usually about 6 months).
The proportion of participants experiencing death
Mortality from any cause. This will be reported as the number and proportion of participants experiencing death, among all participants enrolled in the cohort study.
Measured: his outcome will be assessed during the course of TB treatment (usually about 6 months) and for the 12 months after TB treatment completion.
The proportion of participants experiencing tuberculosis recurrence
Among study participants who achieved tuberculosis treatment completion, this will be defined as a positive sputum culture or an empirical (clinical) diagnosis of TB by healthcare providers in India's National TB Elimination Programme during the 12 months after a participant completed tuberculosis treatment. This will be reported as the number and proportion of participants experiencing TB recurrence, among all participants enrolled in the cohort study who completed TB treatment.
Measured: This outcome will be assessed during the 12 months after completion of tuberculosis treamtent.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2024
- Study start7 Apr 2026
- Primary completion1 Apr 2029 (estimated)
- Study completion1 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tuberculosis, PulmonaryStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Based on NIH definitions, this is considered a clinical trial given that there is prospective assignment of an intervention (i.e., urine isoniazid testing) to evaluate medication adherence. As such, this could be considered a single group/arm study with prospective assignment of the intervention to all study participants.
- Masking
- None (open label)
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
- Collaborators
- Tuberculosis Research Centre, India, Massachusetts General Hospital, National Institute of Allergy and Infectious Diseases (NIAID)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06526221
- Sponsor's protocol ID
- STUDY00004944
- Status last verified
- Jun 2026
- First submitted
- 23 Jul 2024
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Tuberculosis (TB) adherence and outcomes quantitative dataset: This will comprise one quantitative dataset of de-identified individual study participant data from 900 people with TB on treatment, including all quantitative data for the Aim 1 and Aim 2 cohort study. These data will be captured and stored as a Microsoft Excel CSV (comma-separated delimited text) file that can be uploaded into most statistical programs for analysis. As this dataset will be de-identified, individual-level data will be shared publicly through the NIAID Clinical Trials Data Repository (AccessClinicalData@NIAID).
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Urine Isoniazid Testing for Tuberculosis Disease in India to Detect Medication Nonadherence and Improve Treatment Outcomes
- ClinicalTrials.gov ID
- NCT06526221
- Acronym / sponsor ID
- STUDY00004944
- Conditions
- Tuberculosis, Pulmonary, Medication Adherence
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Collaborators
- Tuberculosis Research Centre, India, Massachusetts General Hospital, National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 7 Apr 2026 (actual)
- Primary completion
- 1 Apr 2029 (estimated)
- Study completion
- 1 Apr 2030 (estimated)
- First posted
- 29 Jul 2024 (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.
Tuberculosis (TB) is the leading infectious cause of death globally. India has the largest TB epidemic, accounting for one-quarter of cases and one-third of TB deaths worldwide. Nonadherence to medications is a central challenge in TB care leading to increased death, disease recurrence, and drug resistance. Despite its importance, detecting nonadherence in routine care is challenging, as current measurement approaches are inaccurate, not person-centered, or ineffective at improving outcomes. Early and accurate detection of nonadherence may serve as an entry point for differentiated care, in which people with TB at risk for poor outcomes can be given intensified interventions. Urine isoniazid testing is a validated, low-cost, point-of-care, and direct adherence measure that may be predictive of TB outcomes and therefore serve as an ideal triage test to enable differentiated care. However, to integrate urine testing into routine care, research is needed to: (1) understand how the test performs at scheduled clinic visits, (2) gain a rich understanding of root causes of nonadherence to better leverage urine test results, and (3) identify barriers and facilitators to implementation. In this study, the investigators propose conducting a 900 participant prospective cohort study with translational research involving clinical, behavioral, and implementation science to facilitate integration of urine isoniazid testing into India's national TB program. The investigators' central hypothesis is that urine testing can be integrated into routine care to facilitate early and accurate identification of people with TB who are likely to suffer poor outcomes, including death and TB recurrence. In Aim 1, the investigators will assess the accuracy of urine test results assessed at scheduled clinic visits in comparison to those assessed at unannounced home visits. In Aim 2, the investigators will assess the relationship between nonadherence detected by urine testing and subsequent unfavorable TB outcomes of death, loss to follow-up, treatment failure, and post-treatment TB recurrence.. This study proposal aims to develop an innovative but pragmatic strategy for early identification of TB medication nonadherence that is feasible in low- and middle-income countries with a high TB burden.
Detailed description
Tuberculosis (TB) is the leading infectious cause of death globally. India has the largest TB epidemic, accounting for one-quarter of cases and one-third of global TB deaths. Nonadherence to TB medications is associated with increased death, TB recurrence, and drug resistance. Specifically, missing >10% of doses is associated with six times greater risk of poor TB outcomes.2 The association between nonadherence to TB medications and emergence of drug resistance is one of the most concerning from a public health perspective. For example, one study found that nonadherence to TB therapy was associated with independent elevated risk of acquiring drug resistance (adjusted odds ratio 19.7, 95%CI 1.7-234). Another study found that, among people being treated for multidrug-resistant (MDR) TB, each additional month in which a patient failed to take 80% of their prescribed medication doses was associated with elevated risk of developing extensively drug-resistant (XDR) TB (adjusted hazard ratio 1.2, 95% CI 1.01-1.4).
Despite its importance, detecting nonadherence in routine care is challenging, especially as TB programs in low- and middle-income countries (LMICs) have moved away from directly observed therapy. Our research shows indirect measures-e.g., cellphone-based technology, pill counts, and patient-reported measures-miss detecting >30% of people with TB who are nonadherent by urine isoniazid testing.
Urine isoniazid testing is a low-cost, validated, direct point-of-care adherence measure that is predictive of TB outcomes. In a 650-participant cohort study in India, one unannounced home visit was conducted for each participant during TB therapy to conduct urine testing. That study found: (1) nonadherence was common by urine testing, with 18% of participants having missed more than 1 dose, and (2) negative urine test results were associated with 3.9 increased odds of death and 3.8 increased odds of loss to follow-up from treatment.
While urine testing has benefits, further research is needed to evaluate its uses under TB programs setting First, urine testing may perform differently in clinic as compared to unannounced home visits, as people with TB may modify adherence behavior in anticipation of scheduled clinic visits. Research is needed to understand how well testing at clinic visits represents adherence and predicts TB outcomes. Second, research is needed to understand reasons for nonadherence (i.e., negative urine test results) to inform personalized interventions for differentiated care. Third, implementation science research is needed to evaluate the use of urine testing in routine care in a manner that could lead to sustained use and impact.
The investigators propose conducting translational research involving clinical, behavioural, and implementation science to evaluate the use of urine isoniazid testing in the TB program. The investigators' central hypothesis is that urine testing could be useful within the routine care to facilitate early and accurate identification of people with TB who are likely to suffer poor outcomes, including death and TB recurrence. If this hypothesis is correct, the urine assay could serve as a triage test for developing differentiated care strategies, in which people at risk for poor outcomes are identified early and given intensified care
The investigators have the following specific aims:
Aim 1. To assess the agreement between urine test results collected at prescheduled clinic in comparison to unannounced home visits.
Summary of this aim: The investigators will enroll a cohort of 900 people starting 6-month drug-susceptible TB therapy. For each participant, to enable comparison of clinic and home samples, the investigators will conduct 1 urine test at a scheduled clinic visit and 1 urine test at an unannounced home visit during each of the intensive (first 2 months), early continuation (second 2 months), and late continuation (last 2 months) treatment phases.
Aim 2. To assess the relationship between nonadherence by urine testing and subsequent TB outcomes.
Summary of this aim: The investigators will follow the Aim 1 cohort participants through the completion of TB treatment (which usually takes 6 months) and then for 12 months after treatment and assess the following unfavorable outcomes: death, treatment failure, loss to follow-up, and TB recurrence. The investigators will assess the association between nonadherence by urine testing (separately for clinic and home samples) and the composite of these unfavorable outcomes (primary outcome) and with each unfavorable outcome individually (secondary outcomes).
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Based on NIH definitions, this is considered a clinical trial given that there is prospective assignment of an intervention (i.e., urine isoniazid testing) to evaluate medication adherence. As such, this could be considered a single group/arm study with prospective assignment of the intervention to all study participants.
| Arm | Type | Receives |
|---|---|---|
| Urine isoniazid testing (intervention arm) | Experimental | Diagnostic Test: Urine isoniazid testing (IsoScreen test)This is the only study group/arm in this study. Participants in this study arm will receive urine isoniazid testing using the IsoScreen test in the TB clinic at monthly clinical and medication refill visits at month 1, 2, 3, 4, and 5 (5 times total). The will also undergo urine isoniazid testing using the IsoScreen test at home visits after months 1, 3, and 5 of treatment (3 times total). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18+ years of age,
- presumed or confirmed drug-susceptible pulmonary TB (with or without a previous TB history), and
- taking an isoniazid-containing TB regimen.
Key exclusion criteria (2 listed)
- inability to provide informed consent, or
- drug-resistant TB diagnosis or switch to another non-isoniazid-containing regimen (Note that this second exclusion criteria may result in retrospective exclusion from the study).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Urine isoniazid testing (IsoScreen test)Developed by Arkansas' Public Health Service in the 1970s, this test detects metabolites of isoniazid, a drug present in drug-susceptible TB regimens. IsoScreen (GFC Diagnostics, UK) is a commercial version of the Arkansas method with reagents enclosed in a plastic vial, into which 2mL of urine can be injected with a syringe. If the urine contains isoniazid, reagents turn purple/blue (suggesting a dose was taken in the last 24 hours or appropriate adherence) or green (suggesting a dose was taken 24-48 hours before or one missed dose). A yellow result (no color change) suggests medication has not been taken for >48 hours (two or more missed doses). | Diagnostic test | Urine isoniazid testing (intervention arm) |
Primary outcome
The proportion of participants experiencing a composite unfavorable tuberculosis treatment outcome
Time frame: This outcome will be assessed during the course of TB treatment (usually about 6 months) and for the 12 months after TB treatment completion.
The primary outcome will comprise the composite of: (1) loss to follow-up during treatment, (2) treatment failure, (3) death during the on-treatment or post-treatment period, and (4) TB recurrence. This will be reported as the number and proportion of participants experiencing one of the unfavorable outcomes, among all participants enrolled in the cohort study.
4 secondary outcomes
The proportion of participants lost to follow-up during tuberculosis treatment
Time frame: This outcome will be assessed during the course of TB treatment (usually about 6 months).
The proportion of participants experiencing treatment failure (i.e., failure of tuberculosis treatment)
Time frame: This outcome will be assessed during the course of TB treatment (usually about 6 months).
The proportion of participants experiencing death
Time frame: his outcome will be assessed during the course of TB treatment (usually about 6 months) and for the 12 months after TB treatment completion.
The proportion of participants experiencing tuberculosis recurrence
Time frame: This outcome will be assessed during the 12 months after completion of tuberculosis treamtent.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Individual participant dataSharing planned: Yes. Tuberculosis (TB) adherence and outcomes quantitative dataset: This will comprise one quantitative dataset of de-identified individual study participant data from 900 people with TB on treatment, including all quantitative data for the Aim 1 and Aim 2 cohort study. These data will be captured and stored as a Microsoft Excel CSV (comma-separated delimited text) file that can be uploaded into most statistical programs for analysis. As this dataset will be de-identified, individual-level data will be shared publicly through the NIAID Clinical Trials Data Repository (AccessClinicalData@NIAID).
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Urine isoniazid testing (IsoScreen test) in people with Tuberculosis, Pulmonary and Medication Adherence, run by Tufts University at 2 sites in India.
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 3 inclusion and 2 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: enrolling by invitation, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in India. 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?
This study is still under way. Results are not available in the source record yet.
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?
The proportion of participants experiencing a composite unfavorable tuberculosis treatment outcome (time frame: This outcome will be assessed during the course of TB treatment (usually about 6 months) and for the 12 months after TB treatment completion.). 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 4 Jun 2026.