Pathogenesis and Management of M. Ulcerans Disease, Buruli Ulcer

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02153034
• Date of registration: 28/05/2014
• Prospective Registration: No
• Primary sponsor: Kwame Nkrumah University of Science and Technology
• Public title: Pathogenesis and Management of M. Ulcerans Disease, Buruli Ulcer Buruli_Path
• Scientific title: A Study of the Pathogenesis and Management of M. Ulcerans Disease, Buruli Ulcer
• Date of first enrolment: May 2013
• Target sample size: 400
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT02153034
• Study type: Observational
• Phase: N/A

Countries of recruitment

Ghana

Contacts

• Name: Richard O Phillips, FWACP,FGCP
• Affiliation: Kwame Nkrumah University of Science and Technology

Key inclusion & exclusion criteria

Inclusion Criteria:

- All patients 5 years old or more diagnosed as having Buruli ulcer.

- Age-matched household contacts of patients that present with Buruli ulcer and healthy
volunteers living in Buruli ulcer non-endemic communities

Exclusion Criteria:

- Patients aged less than 5 years and those

- Unwilling to give informed consent



Age minimum: 5 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Mycobacterium Ulcerans Disease

Buruli Ulcer

Primary Outcome(s)

Measurement of serum/plasma proteins in diseased and healthy subjects [Time Frame: Assessed for diseased participants at baseline, 8, 12, 16 weeks and only at baseline for healthy subjects]

Secondary Outcome(s)

Viable M. ulcerans and bacterial load measurement in tissue of diseased subjects [Time Frame: Assessed at baseline, 4, 8, 12, 16 only if lesions are not healed]

Secondary ID(s)

MR/J01477X/1

Source(s) of Monetary Support

Please refer to primary and secondary sponsors