Telacebec (T) Treatment in Adults With Buruli Ulcer (BU). (TREAT BU)
ConditionBuruli Ulcer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBarwon Health
About this trial
The goal of this interventional clinical trial is to demonstrate the complete BU lesion healing rate by 52 weeks after treatment initiation, without relapse and/or curative intent excision surgery, after 10-28 days of telacebec (T) treatment. Males and females age 18 and older will be included.
• Participants will attend visits every 2 weeks during treatment and thereafter every 2 weeks until week 24 Thereafter they will be followed by visits at weeks 30, 40, and 52. From week 10 to week 52, if the lesion has healed, follow-up visits may be remote.
Eligibility criteria
Qualifiers
Positive PCR or culture for confirmation of presence of mycobacterium ulcerans (MU).
Aged 18 years and older, except for those included in exclusion below.
Disqualifiers
Any non BU related condition where participation in the study, as judged by the Investigator, could compromise the well-being of the participant or prevent, limit or confound protocol specified treatment and assessments.
History or current ascites, jaundice, myasthenia gravis, clinically significant renal dysfunction [estimated glomerular filtration rate (eGFR) < 30 mls/min],
Compromised immune status (e.g. uncontrolled HIV-infection)
History of previous BU in the previous 12 months (except current infection)
Trial design
Treatments tested in this trial
- Telacebec
Treatment groups
200 Participants
are divided into 1 treatment groupSponsors and collaborators
Barwon Health
Lead sponsor
Global Alliance for TB Drug Development
Collaborator
Source ClinicalTrials.gov