Status:

NOT_YET_RECRUITING

Evaluating Urine Isoniazid Testing to Detect Nonadherence to Tuberculosis Medications in India

Lead Sponsor:

Tufts University

Collaborating Sponsors:

Tuberculosis Research Centre, India

Massachusetts General Hospital

Conditions:

Tuberculosis, Pulmonary

Medication Adherence

Eligibility:

All Genders

18+ years

Phase:

NA

Brief 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 medica...

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 medica...

Eligibility Criteria

Inclusion

  • 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.

Exclusion

  • 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).

Key Trial Info

Start Date :

April 1 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

September 30 2028

Estimated Enrollment :

900 Patients enrolled

Trial Details

Trial ID

NCT06526221

Start Date

April 1 2025

End Date

September 30 2028

Last Update

January 6 2025

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