EDCTP Alumni Network

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All Profiles
Call Senior Fellowship (SF)
Programme EDCTP2
Start Date 2018-04-01
End Date 2023-03-31
Project Code TMA2016SF1509
Status Active

Title

Evaluation of a nitric oxide generating dressing (EDX) to improve management of Buruli ulcer disease

Objectives

PRIMARY OBJECTIVES • A comparison of rate of healing of ulcers between EDX110 with oral rifampicin and clarithromycin (“EDX-RC”) and Vaseline gauze dressings with oral rifampicin and clarithromycin (“VG-RC”). SECONDARY OBJECTIVES • To compare the tolerability of the two dressings • To evaluate the relationship between treatment, the immune profile and healing in each treatment arm • To compare the rate of bacterial killing of M. ulcerans in each treatment arm EXPLORATORY OBJECTIVES • To evaluate the quality and cosmetic appearance of healing • To document healing in lesions that have not ulcerated within 2 weeks of start of treatment. • To document recurrence rate and paradoxical reactions in the two treatment arms.

Host Organisation

Institution Country
Kwame Nkrumah University of Science and Technology (KNUST) Ghana

Participants

Name Institution Country
220 Kumasi Center for Collaborative Research into Tropical Medicine Ghana

Study Design

A prospective randomised open-blinded end-point (PROBE) study of EDX dressing, compared to current standard of care. The design will comply with site-specific protocols for routine best practice ulcer care using vaseline gauze dressings. The comparator will consist of EDX110 applied to the wound, combined with standard antibiotic treatment. In both groups, dressing treatment will continue until the wound has healed plus up to 7 days. The duration of antibiotic treatment will be 8 weeks.

Sites

Agogo Presbyterian Hospital (APH) in the Asante- Akim district
Tepa government hospital, in the Ahafo Ano North district
Dunkwa government hospital in the Upper Denkyira district in the central region.

Phd Study

Title University Start Date End Date
Immunopathogenesis of M. ulcerans University of London 2002-03-01 2005-06-01

Students Supervised

Type Name Title University Start Date End Date
PhD Jonathan Kofi Adjei Mphil Kwame Nkrumah University of Science and Technology 2019 2023
PhD Bernadette Agbavor Mphil Kwame Nkrumah University of Science and Technology 2019 2023
PhD Nancy Ackam Mphil Kwame Nkrumah University of Science and Technology 2019 2023
PhD Isaac Acheampong Mphil Kwame Nkrumah University of Science and Technology 2021 2025
Mphil Wilfred Aniagyei Bsc Kwame Nkrumah University of Science and Technology 2019 2021
Mphil Venus N. B. Frimpong Bsc Kwame Nkrumah University of Science and Technology 2019 2021
Mphil Difery Minadzi Bsc Kwame Nkrumah University of Science and Technology 2019 2021
Mphil Monika M. Vivekanandan Bsc Kwame Nkrumah University of Science and Technology 2019 2021
Mphil Rejoice A. Arthur Bsc Kwame Nkrumah University of Science and Technology 2019 2021

Results & Outcomes

In this thesis, I have studied the immune response in peripheral blood and at the site of disease of Ghanaian patients with Buruli ulcer caused by M. ulcerans infection. A modified polymerase chain reaction for M. ulcerans in punch biopsies was optimized and evaluated alongside Ziehl Neelsen staining for acid fast bacilli, culture and histology for selection of patients with Buruli ulcer. PCR was 98% sensitive whereas microscopy, culture and histology were 42%, 49% and 82% sensitive respectively. Studies of cytokine production in whole blood after stimulation with M. ulcerans and M. tuberculosis antigens showed that the IL-10 response started early and declined after healing whereas the IFN-g response developed later and was maintained after healing. There was cross reactivity between M. ulcerans and M. tuberculosis antigens but M. ulcerans sonicate was more specific. Studies of the local immune response using real time PCR to measure cytokine mRNA showed that Th1 and Th2 cytokines were expressed concurrently and there was no significant difference between ulcers and nodules but the median IFN-g mRNA expression for ulcers was higher than that in nodules reflecting what was found in the systemic response. Interleukin-8, associated with an acute neutrophilic response, was co-expressed with IL-1b, TNF-a, IL-12p35 and IL-12p40 whereas IFN-g, TNF-a, IL-12p35, IL-12p40, IL-1a, IL-8 and IL-15 expression was found in lesions containing granulomas.

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