Telacebec (T) Treatment in Adults With Buruli Ulcer (BU). (TREAT BU)

Recruiting Phase 2 Interventional Study
Buruli Ulcer
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
200 (estimated)
Sponsor
Barwon Health · Government
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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 wee…
Trial Locations
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Eligibility Criteria
Major Inclusion Criteria: * Clinical diagnosis of BU WHO categories, single or multiples: Category I- a single lesion \< 5 cm Category II - a single lesion with cross-sectional diameter ≤ 10 cm Category III - where multiple and all lesions are ≤ 10 cm cross-sectional diameter * Positive PCR or cu…
Contacts

Bree Sarah

+61 (03) 4215 3035

BREE.SARAH@barwonhealth.org.au

CONTACT

Kate Ellis

+61 (03) 4215 2878

KATHRYN.ELLIS@barwonhealth.org.au

CONTACT