A5300B/I2003B/PHOENIX, Protecting Households On Exposure to Newly Diagnosed Index Multidrug-Resistant Tuberculosis Patients

Study Location:

India

Topic:

Household ContactsTuberculosis

Clinicaltrials.gov Link:

https://clinicaltrials.gov/ct2/show/NCT03568383?term=A5300B%2FI2003B%2FPHOENIX&rank=1

IRB#:

IRB00191637

Coordinator:

Nishi Suryavanshi, PhD

Enrollment:

Open

Trial Period:

Ongoing

This study will 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.

If at least one HHC within a household (HH) is found to be eligible, the HH will be randomized to one of the following:

Arm A: DLM daily for adults, adolescents, and children, given for 26 weeks.

Arm B: INH daily for adults, adolescents, and children, given for 26 weeks AND pyridoxine (vitamin B6) daily for adults, adolescents, and children, given for 26 weeks.

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

All participants will be in the study for 96 weeks. At study entry, index cases will undergo a medical history review and sputum collection. HHCs will have study visits at study entry and at Weeks 2, 4, 8, 12, 16, 20, 26, 36, 48, 60, 72, 84, and 96. Visits may include physical examinations; blood, urine, and sputum collection; electrocardiograms (ECGs); and questionnaires and assessments. Forty HHCs under the age of 5 taking DLM will undergo an intensive PK visit at Week 8.

Men and women age greater than or equal to 18 year

Start date: 8/19/2019

Categories

Location
Topic

Clinical Trials

A5322: Long-Term Follow-up of Older HIV-infected Adults in...

The A5322 protocol is a long-term observational study, with a planned series of analyses of data to be collected from an...

Read More

P1070, Dose-Finding and Pharmacogenetic Study of Efavirenz...

Efavirenz (EFV) is an anti-HIV medicine that is commonly used to treat HIV infection in adults and children older than 3 years...

Read More

NWCS 414, Evaluation of a Serum Biosignature for Identifying...

We will address our hypothesis using a case-control study design. We plan to leverage the existing biorepository of...

Read More

A5225: Phase I/II Dose-Finding Study of High-Dose...

A5225/HiFLAC is a Phase I/II dose escalation and validation study of the safety, tolerability, and therapeutic effect of an...

Read More

P1077BF: Breastfeeding Version of the PROMISE Study...

1077BF is a randomized strategy trial, which is part of the PROMISE studies (1077BF, 1077FF, P1084s, and 1077HS). The Promoting...

Read More