Buruli-RifDACC: Evaluation of the efficacy and cost-effectiveness of high-dose versus standard-dose rifampicin on outcomes in Mycobacterium ulcerans disease, a protocol for a randomised controlled trial in Ghana [version 1; peer review: 2 approved]
Background: Buruli ulcer (BU) can lead to disfiguring ulcers and permanent disability. The 2030 World Health Organization (WHO) road map for Neglected Tropical Diseases (NTDs) calls for major scaling up in diagnosis and management to eliminate disability due to the disease. Current treatment for BU...
| Main Authors: | , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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F1000 Research Ltd
2022-11-01
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| Series: | NIHR Open Research |
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| Online Access: | https://openresearch.nihr.ac.uk/articles/2-59/v1 |
| _version_ | 1827967930689650688 |
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| author | Abigail Agbanyo Yaw Ampem Amoako Lucy Owusu Jacob Novignon Adwoa Asante-Poku Joseph Tuffour Iris Mosweu Yohannes Hailemichael Charles Opondo Ruth Canter Catherine Pitt Elizabeth Allen Stephen L. Walker Dorothy Yeboah-Manu Richard Odame Phillips Michael Marks |
| author_facet | Abigail Agbanyo Yaw Ampem Amoako Lucy Owusu Jacob Novignon Adwoa Asante-Poku Joseph Tuffour Iris Mosweu Yohannes Hailemichael Charles Opondo Ruth Canter Catherine Pitt Elizabeth Allen Stephen L. Walker Dorothy Yeboah-Manu Richard Odame Phillips Michael Marks |
| author_sort | Abigail Agbanyo |
| collection | DOAJ |
| description | Background: Buruli ulcer (BU) can lead to disfiguring ulcers and permanent disability. The 2030 World Health Organization (WHO) road map for Neglected Tropical Diseases (NTDs) calls for major scaling up in diagnosis and management to eliminate disability due to the disease. Current treatment for BU is with daily oral rifampicin (10mg/kg dose) and clarithromycin (15mg/kg dose) for eight weeks, combined with standard gauze wound dressings. Dialkylcarbamoyl chloride (DACC)-coated dressings have been shown to irreversibly bind bacteria on wound surfaces resulting in their removal when dressings are changed. This trial aims to determine whether combining a high-dose oral rifampicin regimen with DACC dressings can improve the rate of wound healing relative to standard-dose oral rifampicin combined with DACC dressings. Methods: This is an individual, multi-centre Phase 3 randomised controlled trial, which will be conducted in three clinical sites in Ghana. The primary outcome measure will be the mean time to clearance of viable mycobacteria. Cost and health-related quality of life data will be collected, and a cost-effectiveness analysis will be performed. Discussion: The findings from this trial could lead to a change in how BU is treated. A shorter but more efficacious regimen would lead to improved treatment outcomes and potentially substantial financial and economic savings. Trial registration Pan African Clinical Trials Repository (registration number; PACTR202011867644311). Registered on 30th November 2020. |
| first_indexed | 2024-04-09T18:13:25Z |
| format | Article |
| id | doaj.art-592936ee4283408db2a8f0373a61956c |
| institution | Directory Open Access Journal |
| issn | 2633-4402 |
| language | English |
| last_indexed | 2024-04-09T18:13:25Z |
| publishDate | 2022-11-01 |
| publisher | F1000 Research Ltd |
| record_format | Article |
| series | NIHR Open Research |
| spelling | doaj.art-592936ee4283408db2a8f0373a61956c2023-04-13T11:02:16ZengF1000 Research LtdNIHR Open Research2633-44022022-11-01214458Buruli-RifDACC: Evaluation of the efficacy and cost-effectiveness of high-dose versus standard-dose rifampicin on outcomes in Mycobacterium ulcerans disease, a protocol for a randomised controlled trial in Ghana [version 1; peer review: 2 approved]Abigail Agbanyo0https://orcid.org/0000-0003-3186-4242Yaw Ampem Amoako1https://orcid.org/0000-0002-4642-789XLucy Owusu2https://orcid.org/0000-0002-7241-4187Jacob Novignon3https://orcid.org/0000-0002-4718-9328Adwoa Asante-Poku4https://orcid.org/0000-0001-8929-193XJoseph Tuffour5Iris Mosweu6Yohannes Hailemichael7https://orcid.org/0000-0002-4831-6077Charles Opondo8https://orcid.org/0000-0001-8155-4117Ruth Canter9Catherine Pitt10Elizabeth Allen11Stephen L. Walker12https://orcid.org/0000-0002-2034-8376Dorothy Yeboah-Manu13https://orcid.org/0000-0002-1663-6287Richard Odame Phillips14Michael Marks15https://orcid.org/0000-0002-7585-4743Kumasi Centre for Collaborative Research, Kumasi, GhanaKumasi Centre for Collaborative Research, Kumasi, GhanaKumasi Centre for Collaborative Research, Kumasi, GhanaKumasi Centre for Collaborative Research, Kumasi, GhanaNoguchi Memorial Institute for Medical Research, University of Ghana, Accra, GhanaNoguchi Memorial Institute for Medical Research, University of Ghana, Accra, GhanaLondon School of Hygiene and Tropical Medicine, London, UKArmauer Hansen Research Institute, Addis Ababa, EthiopiaLondon School of Hygiene and Tropical Medicine, London, UKLondon School of Hygiene and Tropical Medicine, London, UKLondon School of Hygiene and Tropical Medicine, London, UKLondon School of Hygiene and Tropical Medicine, London, UKLondon School of Hygiene and Tropical Medicine, London, UKNoguchi Memorial Institute for Medical Research, University of Ghana, Accra, GhanaKumasi Centre for Collaborative Research, Kumasi, GhanaLondon School of Hygiene and Tropical Medicine, London, UKBackground: Buruli ulcer (BU) can lead to disfiguring ulcers and permanent disability. The 2030 World Health Organization (WHO) road map for Neglected Tropical Diseases (NTDs) calls for major scaling up in diagnosis and management to eliminate disability due to the disease. Current treatment for BU is with daily oral rifampicin (10mg/kg dose) and clarithromycin (15mg/kg dose) for eight weeks, combined with standard gauze wound dressings. Dialkylcarbamoyl chloride (DACC)-coated dressings have been shown to irreversibly bind bacteria on wound surfaces resulting in their removal when dressings are changed. This trial aims to determine whether combining a high-dose oral rifampicin regimen with DACC dressings can improve the rate of wound healing relative to standard-dose oral rifampicin combined with DACC dressings. Methods: This is an individual, multi-centre Phase 3 randomised controlled trial, which will be conducted in three clinical sites in Ghana. The primary outcome measure will be the mean time to clearance of viable mycobacteria. Cost and health-related quality of life data will be collected, and a cost-effectiveness analysis will be performed. Discussion: The findings from this trial could lead to a change in how BU is treated. A shorter but more efficacious regimen would lead to improved treatment outcomes and potentially substantial financial and economic savings. Trial registration Pan African Clinical Trials Repository (registration number; PACTR202011867644311). Registered on 30th November 2020.https://openresearch.nihr.ac.uk/articles/2-59/v1Buruli ulcer Randomised Controlled Trial High Dose Rifampicin DACC cost-effectiveness eng |
| spellingShingle | Abigail Agbanyo Yaw Ampem Amoako Lucy Owusu Jacob Novignon Adwoa Asante-Poku Joseph Tuffour Iris Mosweu Yohannes Hailemichael Charles Opondo Ruth Canter Catherine Pitt Elizabeth Allen Stephen L. Walker Dorothy Yeboah-Manu Richard Odame Phillips Michael Marks Buruli-RifDACC: Evaluation of the efficacy and cost-effectiveness of high-dose versus standard-dose rifampicin on outcomes in Mycobacterium ulcerans disease, a protocol for a randomised controlled trial in Ghana [version 1; peer review: 2 approved] NIHR Open Research Buruli ulcer Randomised Controlled Trial High Dose Rifampicin DACC cost-effectiveness eng |
| title | Buruli-RifDACC: Evaluation of the efficacy and cost-effectiveness of high-dose versus standard-dose rifampicin on outcomes in Mycobacterium ulcerans disease, a protocol for a randomised controlled trial in Ghana [version 1; peer review: 2 approved] |
| title_full | Buruli-RifDACC: Evaluation of the efficacy and cost-effectiveness of high-dose versus standard-dose rifampicin on outcomes in Mycobacterium ulcerans disease, a protocol for a randomised controlled trial in Ghana [version 1; peer review: 2 approved] |
| title_fullStr | Buruli-RifDACC: Evaluation of the efficacy and cost-effectiveness of high-dose versus standard-dose rifampicin on outcomes in Mycobacterium ulcerans disease, a protocol for a randomised controlled trial in Ghana [version 1; peer review: 2 approved] |
| title_full_unstemmed | Buruli-RifDACC: Evaluation of the efficacy and cost-effectiveness of high-dose versus standard-dose rifampicin on outcomes in Mycobacterium ulcerans disease, a protocol for a randomised controlled trial in Ghana [version 1; peer review: 2 approved] |
| title_short | Buruli-RifDACC: Evaluation of the efficacy and cost-effectiveness of high-dose versus standard-dose rifampicin on outcomes in Mycobacterium ulcerans disease, a protocol for a randomised controlled trial in Ghana [version 1; peer review: 2 approved] |
| title_sort | buruli rifdacc evaluation of the efficacy and cost effectiveness of high dose versus standard dose rifampicin on outcomes in mycobacterium ulcerans disease a protocol for a randomised controlled trial in ghana version 1 peer review 2 approved |
| topic | Buruli ulcer Randomised Controlled Trial High Dose Rifampicin DACC cost-effectiveness eng |
| url | https://openresearch.nihr.ac.uk/articles/2-59/v1 |
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