Buruli ulcer study extended after positive results

The Barwon Health Infectious Diseases Unit is extending the world-first clinical trial to continue testing the effectiveness and safety of a new specific antibiotic called Telacebec in the treatment of Buruli Ulcer.

Buruli Ulcer is a skin disease caused by the bacterium, Mycobacterium ulcerans. The toxins made by the bacteria destroy skin cells, small blood vessels and the fat under the skin, which leads to ulceration and skin loss. The disease leads to significant physical and psychological illness that can be long-standing and come at considerable cost to the patient and community.

The number of people affected by Buruli ulcer in our community is increasing as the disease continues to spread within the suburbs of Geelong, the Bellarine Peninsula and the Surf Coast.

Researchers at Barwon Health, with the support of Royal Melbourne, are planning to extend the trial to another 80 patients from July 2025 after very promising preliminary results from the first 40 patients who we successfully enrolled last year.

This trial extension will be focusing on the Geelong, Bellarine Peninsula and Surf Coast regions and well as the Mornington Peninsula and inner north-western suburbs of Melbourne.

Director of Barwon Health’s Infectious Disease department, Professor Daniel O’Brien, said the initial trial showed very positive results for patients,

“We saw all 40 patients safely complete their antibiotic treatment without having to stop or interrupt treatment due to side-effects which is a much better outcome than the current treatments. There were also no serious side-effects reported.”

“Patients also found the antibiotic was easier to take, required less pills and was one month shorter than the usual antibiotics.”

“However, the most important outcome was that healing times were excellent with no patients requiring surgery for their treatment”, he said.

One person who can attest to the positive results of the first part of the trial is Highton woman Lisa Gowers.

Lisa first noticed her elbow was slightly swollen in June last year. After initially being treated for tendonitis and cellulitis, the skin eventually broke down forming an ulcer. By mid-July Lisa received the diagnosis of Buruli ulcer before seeing Professor O’Brien at Barwon Health’s Infectious Disease Clinic.

Lisa was one of the first intake of patients on the Telacebec trial and has had a very positive result with her ulcer fully healing with no side effects from the treatment,

“While I was ‘unlucky’ to contract a Buruli ulcer, I consider myself very lucky to have been a participant in the trial. I arrived at my first appointment at the Infectious Diseases Clinic highly stressed, desperate to find out how to stop the ulcer from growing but dreading what the treatment was going to entail. I left greatly relieved, with a treatment plan and the trial drugs that proved to be highly effective, with healing visible within weeks, while completely devoid of side effects. It certainly worked for me, and I highly recommend the trial to anyone unfortunate enough to contract a Buruli ulcer,” she said.

Through this clinical trial, which is supported by the World Health Organisation, the aim is for Buruli Ulcer treatment to be significantly shorter (reduced to 4 weeks), require only one antibiotic, be safer and more tolerable, have less drug interactions and result in significantly shorter healing times for BU lesions.

It is hoped through our study that the use of Telacebec monotherapy will become the world recognised standard of care for Buruli ulcer, and also lead to improvements in treatment for Tuberculosis and Leprosy.

If you are diagnosed with a Buruli ulcer and would like to consider being treated with this promising new antibiotic, please ask your doctor for a referral to the Infectious Diseases Service at Barwon Health or call Adrian Costa Clinical Trials Centre on 03 4215 2878 for more information.