Protecting Households On Exposure to Newly Diagnosed Index Multidrug-Resistant Tuberculosis Patients

Summary

The purpose of this study is to compare the efficacy and safety of 26 weeks of delamanid (DLM) versus 26 weeks of isoniazid (INH) for preventing confirmed or probable active tuberculosis (TB) during 96 weeks of follow-up among high-risk household contacts (HHCs) of adults with multidrug-resistant tuberculosis (MDR-TB) (index cases). High-risk HHCs are those with HIV or non-HIV immunosuppression, latent TB infection, and young children below the age of 5 years.

Conditions

• Tuberculosis, MDR

Interventions

DRUG

Delamanid (DLM)

Adults and children ≥30 kg: delamanid 200 mg orally once daily. Children ≥2.5 kg to \<30 kg: weight-band dosing orally once daily as per the study protocol. As children gain weight, their DLM dose should be adjusted, typically every month or as the visit schedule permits.

DRUG

Isoniazid (INH)

Adults and children ≥24 kg: INH 300 mg orally once daily. Children ≥2.5 kg to \<24 kg: INH weight-band dosing orally once daily as per the study protocol. As children gain weight, their INH dose should be adjusted.

DIETARY_SUPPLEMENT

Pyridoxine (vitamin B6)

All HHCs in Arm B must receive pyridoxine (vitamin B6) with each dose of INH based on the current local dosing guidelines. For children up to 3 years of age and nursing women, pyridoxine will be given as per local standard of care. Pyridoxine is not supplied through the study.

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  collaborator NIH

• Otsuka Pharmaceutical Development & Commercialization, Inc.

  collaborator INDUSTRY

• National Institute of Allergy and Infectious Diseases (NIAID)

  lead NIH

Principal Investigators

• Gavin Churchyard, MBBCh MMed FRCP FCP(SA) PhD · Aurum Institute

• Amita Gupta, MD, MHS · Johns Hopkins Medical Institutions, Center for Clinical Global Health Education

• Anneke Hesseling, MD, PhD · University of Stellenbosch

• Susan Swindells, MBBS · University of Nebraska

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-06-03

Primary Completion

2027-01-11

Completion

2027-01-11

FDA Drug

Yes

Countries

• Botswana
• Brazil
• Haiti
• India
• Kenya
• Peru
• Philippines
• South Africa
• Tanzania
• Thailand
• Uganda
• Vietnam
• Zimbabwe

Study Locations