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: www.pactr.org
Trial no.: PACTR201812819039144 Date of Approval: 21/12/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Evaluation of a nitric oxide generating dressing (EDX110) to improve management of Buruli ulcer disease (BURULINOX)
Official scientific title Evaluation of a nitric oxide generating dressing (EDX110) to improve management of Buruli ulcer disease (BURULINOX)
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 novel nitric oxide-generating wound dressing to rapidly kill Mu and enhance healing. Primary Objective • A comparison of healing, as measured by percentage area reduction, of EDX110 dressing with oral rifampicin and clarithromycin (EDX-RC) versus ‘Usual Care’ with routine Vaseline gauze dressing and oral rifampicin and clarithromycin (VG-RC). Secondary Objectives • A comparison of the number of complete healers • A comparison of rate of killing of M. ulcerans in EDX dressing and Vaseline gauze dressing groups. • A comparison of recurrence rate in EDX dressing and Vaseline gauze dressing groups . • Effect of treatment on the immune profiles of stimulated blood cells for biomarkers of healing • A comparison of the tolerability of the two dressings. STUDY DESIGN A prospective randomised open-blinded end-point (PROBE) study of either rifampicin 10mg/kg and clarithromycin 15mg/kg daily AND NOx-generating gel dressing (EDX) applied on alternate days to the wound (RC-EDX) or rifampicin 10mg/kg and clarithromycin 15mg/kg daily AND vaseline gauze dressings applied daily to the wound (RC) representing current standard of care. Primary endpoint: Comparison of the time to complete healing of lesions. Secondary End points: Comparison of the time to complete killing of M. ulcerans; comparison of proportion of patients expressing T cell markers associated with
Type of trial RCT
Acronym (If the trial has an acronym then please provide) BURULINOX
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 01/03/2019
Actual trial start date
Anticipated date of last follow up 01/04/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 220
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
Experimental Group EDX110 Alternate day topical application of one dressing Until the wound has healed plus 7 days, with a minimum duration of 3 weeks Topically applied wound dressing 110
Control Group Vaseline gauze dressing Daily application of one strip Until the wound has healed plus 7 days, with a minimum duration of 3 weeks Topical wound dressing 110 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
i. Male or female Buruli ulcer patients aged 5 years or older. ii. With a nodule, plaque or ulcer <15cm diameter, with or without associated oedema. iii. The lesion must have been tested positive for M. ulcerans by PCR for IS2404 iv. Able to give informed consent. v. Able and willing to follow the protocol requirements i. Female patients who are pregnant or breast-feeding. ii. Any other serious disease likely to compromise the outcome of the trial. iii. Participation in any interventional study during the 8 weeks preceding the intervention period of the study. iv. Known allergy to any component of EDX dressing 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) 79 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 10/10/2017 School of Medical Sciences and Komfo Anokye Teaching Hospital Committee on Human Research Publication and Ethics
Ethics Committee Address
Street address City Postal code Country
Room 7 Block J, SMS Kumasi 0000 Ghana
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Proportion of patients with complete healing in each treatment group At weeks 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48
Secondary Outcome Time to complete killing of M. ulcerans Week 8
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Agogo Presbyterian Hospital Agogo High Street Agogo Ghana
Tepa Government Hospital Box 95 Tepa Ghana
Dunkwa Goverment Hospital Box 49 Dunkwa Ghana
FUNDING SOURCES
Name of source Street address City Postal code Country
EDCTP 2509 AA The Hague Netherlands
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Kumasi Centre for Collaborative Research South End Asuogya Road KNUST Kumasi Ghana University
COLLABORATORS
Name Street address City Postal code Country
Dr Mark WansbroughJones Cranmer Terrace SW17 ORE London United Kingdom
Prof Ymkje Stienstra University Medical Center Groningen Hanzeplein 1, 9700RB Groningen Netherlands
Prof. Dr. Marc Jacobsen Moorenstr. 5, 40225 Duesseldorf Germany
Edixomed Ltd 63 Grosvenor Street London United Kingdom
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Richard Phillips rodamephillips@gmail.com +233209140451 South End Asuogya Road KNUST
City Postal code Country Position/Affiliation
Kumasi Ghana Associate Professor in Medicine KCCR KNUST
Role Name Email Phone Street address
Scientific Enquiries Michael Frimpong frimpong@kccr.de +233549187649 South End Asuogya Road KNUST
City Postal code Country Position/Affiliation
Kumasi Ghana Post Doctoral Scientist KCCR
Role Name Email Phone Street address
Public Enquiries Bernadette Agbavor agbavor@kccr.de +233207609035 South End Asuogya Road KNUST
City Postal code Country Position/Affiliation
Kumasi Ghana KCCR
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,Statistical Analysis Plan,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 inn 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
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Age group 20/12/2018 correction to include minimum age of 5 years Child: 6 Year-12 Year, Adolescent: 13 Year-18 Year, Adult: 19 Year-44 Year, Middle Aged: 45 Year(s)-64 Year(s), Aged: 65+ Year(s) Preschool Child: 2 Year-5 Year, Child: 6 Year-12 Year, Adolescent: 13 Year-18 Year, Adult: 19 Year-44 Year, Middle Aged: 45 Year(s)-64 Year(s), Aged: 65+ Year(s)
Section Name Field Name Date Reason Old Value Updated Value
Collaborators Collaborators List 20/12/2018 Editing Dr Mark WansbroughJones, Cranmer Terrace SW17 ORE, London, , United Kingdom
Section Name Field Name Date Reason Old Value Updated Value
Collaborators Collaborators List 20/12/2018 Editing Prof Ymkje Stienstra University Medical Center Groningen, Hanzeplein 1, 9700RB, Groningen, , Netherlands
Section Name Field Name Date Reason Old Value Updated Value
Collaborators Collaborators List 20/12/2018 Editing Prof. Dr. Marc Jacobsen, Moorenstr. 5, 40225 , Duesseldorf, , Germany
Section Name Field Name Date Reason Old Value Updated Value
Collaborators Collaborators List 20/12/2018 Editting Edixomed Ltd, 63 Grosvenor Street, London, , United Kingdom
Section Name Field Name Date Reason Old Value Updated Value
Reporting Plan to share IPD 21/12/2018 Web have agreed to share the IPD Undecided Yes
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD description 21/12/2018 IPD description has been provided 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.
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD-Sharing time frame 21/12/2018 The time for sharing IPD has been provided starting 6 months after publication
Section Name Field Name Date Reason Old Value Updated Value
Reporting Key access criteria 21/12/2018 Access criteria has been described 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 inn addition to details of the data use will also be provided Data access request will be reviewed and decisions will be provided promptly.
Section Name Field Name Date Reason Old Value Updated Value
Reporting Study protocol document 21/12/2018 Additional documents to be made available has been provided Study Protocol, Statistical Analysis Plan, Informed Consent Form