PDF(Pubmed)
Abstract：
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: Pan African Clinical Trials Repository (registration number; PACTR202011867644311). Registered on 30 th November 2020.
Buruli ulcer (BU), caused by Mycobacterium ulcerans, manifests clinically as a wound or swelling. There are several approaches for managing this condition. One is the availability of two antibiotics, usually rifampicin in combination with clarithromycin, that can be used to treat the disease. Rifampicin is thought to be the most important of these two drugs. Scientists have found out that a higher dose of rifampicin is safe and may help improve healing outcome and shorten the duration of treatment. Individuals with BU wounds also go through wound dressing procedures at their hospitals and health centres. Commonly, wounds are dressed using Vaseline gauze and bandages. However, it has been observed that some affected individuals heal faster than others even with the antibiotic treatment. Some still have living organisms in their wounds many weeks after the antibiotic treatment. There is a new dressing material called DACC which is believed to permanently bind bacteria on the wound surface leading to their removal when the dressings are changed. This may be a good way to treat and prevent infection without the use of more drugs. This study 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. Furthermore, cost and health-related quality of life data will be collected and a cost-effectiveness analysis will be performed. 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: Pan African Clinical Trials Repository (registration number; PACTR202011867644311). Registered on 30 th November 2020.
Buruli ulcer (BU), caused by Mycobacterium ulcerans, manifests clinically as a wound or swelling. There are several approaches for managing this condition. One is the availability of two antibiotics, usually rifampicin in combination with clarithromycin, that can be used to treat the disease. Rifampicin is thought to be the most important of these two drugs. Scientists have found out that a higher dose of rifampicin is safe and may help improve healing outcome and shorten the duration of treatment. Individuals with BU wounds also go through wound dressing procedures at their hospitals and health centres. Commonly, wounds are dressed using Vaseline gauze and bandages. However, it has been observed that some affected individuals heal faster than others even with the antibiotic treatment. Some still have living organisms in their wounds many weeks after the antibiotic treatment. There is a new dressing material called DACC which is believed to permanently bind bacteria on the wound surface leading to their removal when the dressings are changed. This may be a good way to treat and prevent infection without the use of more drugs. This study 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. Furthermore, cost and health-related quality of life data will be collected and a cost-effectiveness analysis will be performed. 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.
摘要：
未经授权：布鲁里溃疡（BU）可导致溃疡和永久性残疾。2030年世界卫生组织（WHO）被忽视的热带病（NTD）路线图呼吁大规模扩大诊断和管理，以消除因疾病而导致的残疾。目前BU的治疗是每天口服利福平（10mg/kg剂量）和克拉霉素（15mg/kg剂量），持续八周，结合标准纱布伤口敷料。已显示二烷基氨基甲酰氯(DACC)涂覆的敷料不可逆地结合伤口表面上的细菌,导致当更换敷料时它们被去除。该试验旨在确定相对于标准剂量口服利福平联合DACC敷料，高剂量口服利福平方案联合DACC敷料是否可以提高伤口愈合率。
未经授权：这是个人，多中心3期随机对照试验，这将在加纳的三个临床地点进行。主要结果测量将是清除活分枝杆菌的平均时间。将收集成本和健康相关的生活质量数据，并进行成本效益分析。
UNASSIGNED：这项试验的结果可能导致BU治疗方式的改变。更短但更有效的治疗方案将导致改善的治疗结果和潜在的大量财政和经济储蓄。
未经授权：这是个人，
UNASSIGNED：这项试验的结果可能导致BU治疗方式的改变。
