Clinical Trial of Multi Drug-Resistant TB Treatment Ends Enrolment Early, Offering Hope for TB Patients

24.03.2021

A trial aiming to find a better treatment for multidrug-resistant tuberculosis (MDR-TB) has stopped enrolling patients early after its independent data safety and monitoring board indicated that the regimen being studied is superior to current care, and that more patient data was extremely unlikely to change the trial’s outcome. Swiss TPH’s Clinical Operations Unit is responsible for the monitoring of the trial.

The identification of a dramatically shortened, safe and effective patient friendly treatment could save the lives of hundreds-of-thousand of people with multidrug-resistant tuberculosis. (Photo: Swiss TPH)

Tuberculosis (TB) is a globally spread disease which is caused by the bacteria Mycobacterium tuberculosis. The current standard of care consists of a combination therapy of different antibiotics. However, multidrug-resistant tuberculosis (MDR-TB) strains emerge strongly, complicating efforts to control the global TB epidemic.

TB PRACTECAL is a phase II/III trial sponsored by Médecins Sans Frontières/Doctors Without Borders (MSF) to identify a new treatment regimen for adults with pulmonary multidrug-resistant and extensively drug-resistant tuberculosis. This is the first-ever multi-country, randomised, controlled clinical trial to report on the safety and efficacy of a six-month, all-oral regimen for drug-resistant TB.

In March 2021, the trial’s independent data safety and monitoring board recommended that randomisation of patients into TB-PRACTECAL be stopped, as more data was extremely unlikely to change the results of the trial. As a result, MSF has closed enrolment to new patients last week.

“This is fantastic news for our patients, as it can greatly improve their quality of life. We are very pleased to have supported MSF in finding a shorter, effective treatment regimen with minimal side effects for MDR-TB treatment,” said Elizabeth Reus, Head of the Clinical Operations Unit at Swiss TPH that monitored the clinical trial.

Transforming TB patient treatment

The clinical trial tested a six-month regimen of bedaquiline, pretomanid, linezolid and moxifloxacin, against the locally accepted standard of care. 242 patients were enrolled in seven trial sites across Belarus, South Africa and Uzbekistan. MSF is now preparing a dataset to share with the World Health Organization (WHO), and full results will be submitted to a peer-reviewed journal in the coming months.

Since the first patient was enrolled in the TB-PRACTECAL trial in 2017, new treatments for MDR-TB have become available, but lengthy regimens that patients struggle to complete are still the reality. The WHO’s current guidelines recommend treatment lasting nine to 20 months for patients with MDR-TB.

“The findings could transform the way we treat patients with drug-resistant forms of TB worldwide, who have been neglected for too long.” said Professor David Moore from the London School of Hygiene and Tropical Medicine and a member of the Trial Steering Committee.

More information on TB-PRACTECAL including primary outcome measures can be found here.

Partners in the trial

Médecins Sans Frontières (sponsor); London School of Hygiene and Tropical Medicine; Global Alliance for TB Drug Development; University College London; Drugs for Neglected Diseases initiative; Swiss Tropical & Public Health Institute; eResearch Technology, Inc.; Ministry of Health, Republic of Uzbekistan; Ministry of Health, Belarus; TB & HIV Investigative Network (THINK); University of Liverpool ; Clinical HIV Research Unit, Wits Health Consortium; Hackensack Meridian Health; University of California, San Francisco; University of Sussex.

 

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