Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202011867644311 Date of Approval: 30/11/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Evaluation of High Dose Rifampicin and Dialkylcarbamoyl chloride (DACC)-coated dressings to improve outcomes in Mycobacterium ulcerans disease
Official scientific title Evaluation of High Dose Rifampicin and Dialkylcarbamoyl chloride (DACC)-coated dressings to improve outcomes in Mycobacterium ulcerans disease
Brief summary describing the background and objectives of the trial BACKGROUND Buruli ulcer is a neglected infectious disease (NID) caused by Mycobacterium ulcerans (Mu). It occurs mainly in rural parts of West Africa including Ghana. Treatment with antibiotics, rifampicin with either streptomycin or clarithromycin, has transformed management of Buruli ulcer but it is given for 8 weeks and the rate of healing is highly variable even in patients with seemingly similar lesions. We propose using a high dose rifampicin to be taken for a shorter period and Dialkylcarbamoyl chloride (DACC)-coated wound dressings to improve on the rate of clearance of Mycobacterium ulcerans thereby improving on the management of Buruli ulcer disease. Primary Objective • Compare the time to clearance of viable Mycobacterium from wounds of patients treated with high-dose rifampicin and DACC dressings (HR-DACC) to those receiving standard dose rifampicin and DACC dressings (SR-DACC). Secondary Objectives • Assess impact of high-dose Rifampicin and DACC dressings on the rate of wound healing • Assess the rate of paradoxical reactions between dressing groups • Asses the recurrence rate in both groups • Evaluate the incremental costs and cost-effectiveness of high dose Rifampicin vs standard dose Rifampicin STUDY DESIGN: A prospective randomised open-blinded end-point (PROBE) study of High Dose (20mg/kg) Rifampicin+ standard dose clarithromycin (15mg/kg) administered daily for four weeks and Dialkylcarbamoyl chloride (DACC)-coated dressings to be changed every other day for eight weeks. This will be compared with Standard dose Rifampicin (10mg/kg) + standard dose clarithromycin (15mg/kg)administered daily and Dialkylcarbamoyl chloride (DACC)-coated dressings changed every other day for eight weeks.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) BuruliRIFDACC
Disease(s) or condition(s) being studied Skin and Connective Tissue Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/03/2021
Actual trial start date
Anticipated date of last follow up 27/11/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 112
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Standard dose Rifampicin Clarithromycin and DACC dressing Standard Dose oral Rifampicin (10mg/kg) + standard dose oral clarithromycin (15mg/kg) taken daily for 56 days DACC coated wound dressing to be applied topically on alternate days for 8 weeks Standard dose Oral Rifampicin (10mg/kg) + standard dose oral clarithromycin (15mg/kg) taken daily for 8 weeks (56 days) DACC coated wound dressing applied on alternate days for minimum 8 weeks or until lesion heals Rifampicin/ Clarithromycin - oral antibiotic capsule/ tablets DACC - Dressing- Topical wound dressing 56 Active-Treatment of Control Group
Experimental Group High Dose Rifampicin and DACC Dressing High Dose oral Rifampicin (20mg/kg) + Standard Dose oral Clarithromycin (15mg/kg) taken daily for 28 days DACC coated dressing- topical wound dressing applied on alternate days for 8 weeks- ( until wound heals) High Dose Rifampicin + Clarythromycin - taken daily for 28 days (4 weeks) DACC coated dressing- topical wound dressing applied on alternate days for 8 weeks- ( until wound heals) High Dose Rifampicin - Oral antibiotic capsules Clarythromycin - oral antibiotic tablets DACC coated dressing- topical wound dressing 56
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
i. Age between 5 and 80 years old ii. Have a nodule, plaque or ulcer, with or without associated oedema. iii. Lesion that has tested positive for M. ulcerans by Polymerase Chain Reaction (PCR) for IS2404 iv. Participant or parent/guardian able to give informed consent. v. Able and willing to follow the protocol requirements i. Current participation in any interventional study at the time of randomisation ii. Known allergy to any component of DACC dressing iii. Known contraindication to either Rifampicin or clarithromycin 80 and over: 80+ Year,Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Child: 6 Year-12 Year,Middle Aged: 45 Year(s)-64 Year(s),Preschool Child: 2 Year-5 Year 5 Year(s) 80 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 21/01/2021 Committee on Human Research and Publication Ethics
Ethics Committee Address
Street address City Postal code Country
RM7 Block J SMS, KNUST, Kumasi UPO, PMB Ghana
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Time to clearance of viable mycobacterium from wounds At weeks 2,4, 6, 8
Secondary Outcome • Time to healing of the BU wound between groups • Proportion of patients with paradoxical reaction in each treatment arm • Proportion of patients with recurrence of BU in each treatment arm by 12 months • Proportion of patients with clinical evidence of a secondary infection during their BU treatment • The incremental financial and economic costs per patient of the high dose Rifampicin vs standard dose Rifampicin (from household and provider perspectives) At weeks 2,4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ga west Municipal Hospital Hospital Road, Amasaman Accra Ghana
Pakro Health Center Pakro Nsawam Ghana
Wassa Akropong Government Hospital WX-0001-0488 Wassa Akropong Ghana
FUNDING SOURCES
Name of source Street address City Postal code Country
NIHR Research and Innovation for Global Health Transformation Whitefriars Lewins Mead, Bristol BS1 2NT London United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor London School of Hygiene and Tropical Medicine Keppel Street London WC1E 6JT London United Kingdom University
COLLABORATORS
Name Street address City Postal code Country
Steve Walker London School of Hygiene and Tropical Medicine, Keppel Street London WC1E 7HT London United Kingdom
Catherine Pitt London School of Hygiene and Tropical Medicine, Keppel Street London WC1E 7HT London United Kingdom
Ruth Canter London School of Hygiene and Tropical Medicine, Keppel Street London WC1E 7HT London United Kingdom
Elizabeth Allen London School of Hygiene and Tropical Medicine, Keppel Street London WC1E 7HT London United Kingdom
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Richard Phillips phillips@kccr.de +233209140451 KCCR, South-End Asougya road, KNUST
City Postal code Country Position/Affiliation
Kumasi UPO, PMB Ghana Professor of Medicine Scientific Director of KCCR
Role Name Email Phone Street address
Public Enquiries Yaw Amoako yamoako2002@gmail.com +233244858075 Department of Medicine,Komfo Anokye Teaching Hospital
City Postal code Country Position/Affiliation
Kumasi Ghana Study Clinician
Role Name Email Phone Street address
Scientific Enquiries Michael Marks michael.marks@lshtm.ac.uk +447984643424 Keppel Street London WC1E 6JT
City Postal code Country Position/Affiliation
London United Kingdom Co Investigator
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes IPD that underline results in a publication. Data request will be reviewed by the Principal investigator and decisions will be made available promptly within 3 months of request. There will be a data agreement to be signed. Informed Consent Form,Study Protocol Starting 6 months after publication IPD will be accessed by other researchers upon request and this will be controlled. Data will be made available via a secured data transfer method. Supporting study protocols in addition to details of the data use will also be provided. Data access request will be reviewed and decisions will be provided promptly.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information