MDR TB Clinical Trials

Partnering with The Union and Vital Strategies to Include SHOEBOX Audiometry in Multi-drug Resistant Tuberculosis Clinical Trials

Audiometry, Hearing Health, Ototoxicity Monitoring

I’m on a short plane ride home reflecting on my last few days spent with The International Union Against Tuberculosis and Lung Disease (The Union) and its affiliate Vital Strategies. Together they have been working on a Phase III Clinical Trial to test simpler and shorter treatment regimes for patients suffering from multidrug-resistant tuberculosis (MDR-TB).

Tuberculosis (TB) is a disease caused by bacteria that affects the lungs. In 2014 just over 9.6 million people were newly diagnosed with TB, and there were 1.5 million TB-related deaths worldwide. It is highly infectious and those suffering from a compromised immune system are at a significantly increased risk of becoming symptomatic.

TB is curable and preventable but the bacteria that causes the disease can develop resistance to the drugs used to treat it. This happens for a number of reasons including the incorrect use of the drugs, or through ineffective formulations. In some countries, it is becoming increasingly difficult to treat multidrug-resistant TB. Also in 2014, there were an estimated 480,000 new cases of MDR-TB and it is estimated that this disease killed 190,000 people worldwide that same year.

STREAM is the clinical study being conducted by The Union and Vital Strategies in numerous countries including Mongolia, Ethiopia, and South Africa. They are working to evaluate simpler and shorter treatment regimes for patients with MDR-TB. That’s the good news. The bad news is that some of the other regimes are highly ototoxic meaning that there is a strong possibility of hearing loss as a side effect of being treated for the disease.

That’s why I was in New York meeting with this group. We are so proud to be part of this very important trial. Phase II STREAM sites have begun using SHOEBOX Audiometry – a clinically validated iPad audiometer that performs diagnostic threshold hearing testing – to test patients’ hearing levels. We are working to help equip all of the eligible Phase II sites with SHOEBOX audiometers to monitor this very important side effect. Patients have their hearing testing once admitted into this phase of the trial, and every month thereafter. If a significant deterioration in hearing levels is detected, a change in treatment is often prescribed.

The vast majority of these study patients will not have ever had a hearing test, and although they have other very serious health concerns, it is important to manage impairments that can be prevented. Often in low-resource countries, having hearing loss can be the factor that prevents an individual from finding and/or maintaining employment. This can be devastating not only for that individual but also for the family members that also rely on their income to live. The ability to communicate is one that is often taken for granted and only when it is compromised do we gain an understanding of how crucial it is to our livelihood.

Notably, the Union and its esteemed partners have been so pleased with the capabilities of SHOEBOX Audiometry that they have been recommending it to other groups currently running MDR-TB clinical trials. I speak for the entire Ottawa-based team when I say that we are thrilled at this development and hope to help make a significant impact in the important detection of hearing loss and its prevention worldwide.