A5343: Bedaquiline Delamanid Study

A5343: A Trial of the Safety, Tolerability, and Pharmacokinetics of Bedaquiline and Delamanid, Alone and in Combination, among Participants Taking Multidrug Treatment for Drug-Resistant Pulmonary Tuberculosis

Treatment Category: Tuberculosis

Study Description
This study will compare three treatment arms for people who are diagnosed with multidrug-resistant tuberculosis (MDR-TB) or rifampin-monoresistant tuberculosis (RR-TB) in the lungs. MDR-TB is a form of tuberculosis (TB) that is resistant to two or more of the primary drugs used for the treatment of TB (isoniazid and rifampin). RR-TB is a form of TB that is resistant to rifampin. Participants will receive standard treatment for MDR-TB or RR-TB plus one or two new drugs for TB, called bedaquiline (BDQ) and delamanid (DLM).

Why is this study being done?
This study will look at how the two new drugs fight MDR-TB or RR-TB when used alone with other TB drugs or used together. It will look at how the TB drugs work inside the body and how safe and well tolerated these two drugs are in the individual treatment arms.

Who can join?

  • Age 18 or older
  • Have MDR-TB or RR-TB in the lungs and be on treatment for at least 7 days within the 10 days before entering into the study
  • For HIV-positive participants: CD4 count at or above 100 cells/mm3
  • Cannot have taken or be taking treatment for MDR-TB or RR-TB before joining the study, other than for the qualifying episode
  • Cannot have MDR-TB or RR-TB occurring outside the lungs
  • Cannot have heart problems or other serious illness
  • Willing to stay in hospital for at least 2 months (Potential for this requirement to be shortened at a later point in the trial, if this is deemed safe.)
  • Participants receiving the WHO short course regimen that contains clofazimine, cannot receive more than 21 cumulative days of clofazimine at any time prior to, or at the time of, study entry.

What do I need to do in the study?
Participants will be randomized (assigned by chance) to one of three treatment arms:

  • Arm 1: BDQ
  • Arm 2: DLM
  • Arm 3: Both BDQ and DLM

Participants will receive 24 weeks of study treatment by mouth, followed by 104 weeks of follow-up. Multiple times throughout the study, blood samples will be drawn and an electrocardiogram (ECG)—a test that measures the electrical activity in the heart—will be done to monitor the safety of the drugs.

What treatments or drugs are involved with this study?
BDQ and DLM will be provided for participants.

Study Status: