A5300B: MDR TB Households

A5300B/I2003B/PHOENIx: Protecting Households On Exposure to Newly Diagnosed Index Multidrug-Resistant Tuberculosis Patients (PHOENIx MDR-TB)

Treatment Category: Tuberculosis

Study Description

This is a trial of delamanid (DLM) versus isoniazid (INH) for preventing confirmed or probable active tuberculosis (TB) among high-risk household contacts (HHCs) of adults with multidrug-resistant tuberculosis (MDR-TB). Multidrug-resistant tuberculosis is a form of tuberculosis (TB) that is resistant to two or more of the primary drugs used for the treatment of TB. High-risk HHCs are those with HIV or non-HIV immunosuppression, latent TB infection, and young children below the age of 5 years.

Study Status

Why is this study being done?

This study will compare how safe and effective DLM is versus INH for preventing latent, confirmed, or probable active TB among HIV-infected and other HHCs of MDR-TB patients at high risk of developing TB.

Who can join?
Index Case:  

  • Adult (18 years and older) with MDR-TB in the lungs
  • Started MDR-TB treatment within the past 90 days
  • Has one or more household contacts
  • Gives site staff permission to call and visit the HHCs

Household Contact (HHC):

  • Currently lives or lived with or shares housekeeping duties in the same home as the Index Case
  • Reports exposure to the Index Case within 90 days prior to the Index Case starting MDR-TB treatment, or
  • Spent more than 4 hours indoors with the Index Case during the week before he or she started MDR-TB treatment.
  • Is in one of the following high-risk groups:Children less than 5 years of age
  • Adults, adolescents, and children ≥5 years of age who have a positive TB skin test or blood test, but do not have HIV and are not immunosuppressed.
  • Adults, adolescents, and children ≥5 years of age who have HIV or are non-HIV immunosuppressed

What do I need to do in the study?
After the Index Case is enrolled, the site staff will ask the participant for permission to visit his or her household. If the participant agrees, a household visit will be completed, and all HHCs will be screened for eligibility. Only HHCs of Index Cases who are at high risk of developing TB will be enrolled into the study.

Households will be randomly assigned (assigned by chance) to one of two groups:

  • Group A: Delamanid (DLM) daily
  • Group B: Isoniazid (INH) (with vitamin B6) daily

All high-risk HHCs in the same household will receive the same randomized regimen.

Participants will receive 26 weeks of study treatment by mouth, and will be followed on the study for 96 weeks.  

What treatments or drugs are involved with this study?
Delamanid (DLM) or isoniazid (INH) and pyridoxine (vitamin B6) will be provided for participants.

Study Status: