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.: PACTR201306000520103 Date of Registration: 13/03/2013
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Single dose oral Azithromycin versus injection Benzathine benzylpenicillin in the treatment of yaws- A randomized noninferiority trial in some endemi
Official scientific title Single dose oral Azithromycin versus injection Benzathine benzylpenicillin in the treatment of yaws- A randomized noninferiority trial in some endemic communities in Ghana
Brief summary describing the background and objectives of the trial The standard drug of treatment for yaws is injection Benzathine penicillin but logistical constraints, pain and infection associated with injection poses a problem of acceptability and accessibility of the drug. For the WHO target of eradication to be achieved, there is the need to explore the use of an alternate drug for treatment which will be easier to administer and is more accessible and equally effective as the standard treatment. The main objective of this study is to determine whether oral Azithromycin a macrolide antibiotic with a promising cure results against several disorders including treponema infections can be as effective as injection Benzathine penicillin in the treatment of yaws.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Musculoskeletal Diseases,Skin and Connective Tissue Diseases,Yaws
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 28/02/2011
Actual trial start date 25/05/2011
Anticipated date of last follow up 31/12/2012
Actual Last follow-up date 31/12/2012
Anticipated target sample size (number of participants) 420
Actual target sample size (number of participants) 403
Recruitment status Completed
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation was done using a computer generated sequence to assign cases to either oral Azithromycin or Injection Benzathine benzylpenicillin treatment Kept in sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Oral Azithromycin 30mg/kg once oral 201
Control Group Injection Benzathine Benzylpenicillin 0.6mU-1mU once injection 202 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
¿ The subject aged 1-15 years ¿ The guardian/child has signed/thumb printed written informed consent The subject has clinical diagnosis of primary/secondary yaws The subject has laboratory confirmation of yaws i.e., reactive TPHA and RPR test of at least 1:4 The subject/guardian is willing to make participant available for follow up. ¿ The subject does not have reactive serologic test for yaws The subject has late yaws The subject has known suspected allergy to Penicillin and/or macrolide antibiotics The subject has been on a broad spectrum antibiotic in preceding 30 days The subject is judged by investigator to be unlikely to participate in the study follow 1 Year(s) 15 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 11/02/2011 Ghana Health Service Ethical Review Board
Ethics Committee Address
Street address City Postal code Country
Adabraka Polyclinic, Castle Road Adabraka-Accra GAR Ghana
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 11/02/2011 Ghana Health Service Ethical Review Board
Ethics Committee Address
Street address City Postal code Country
Adabraka Polyclinic, Castle Road Adabraka-Accra GAR Ghana
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Cure at 6 months 6months
Secondary Outcome Clincal cure 3weeks
Secondary Outcome serological cure sixmonths
Secondary Outcome serological cure 3 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ga West municipal health administration Hospital rd. Amasaman-Accra GAR Ghana
FUNDING SOURCES
Name of source Street address City Postal code Country
University of Ghana School of Public Health Noguchi Road Legon-Accra GAR Ghana
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Greater Accra Regional Health Directorate Workers College Road Accra GAR Ghana Commercial Sector/Industry
Primary Sponsor University Of Ghana School Of Public Health Noguchi Road Legon -Accra GAR Ghana University
COLLABORATORS
Name Street address City Postal code Country
World Health Orga 29, Volta Street, Airport Residential Area Accra GAR Ghana
World Health Organisation 29, Volta Street, Airport Residential Area Accra GAR Ghana
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator cynthia Kwakye cindykwakye@yahoo.com 233244121272 29 martey tsuru street
City Postal code Country Position/Affiliation
east airport-accra GAR Ghana Deputy Director of Health
Role Name Email Phone Street address
Public Enquiries Patrick Nsiiri Agana agana.nsiire@gmail.com 233 244 292170 Court 6, block b2, Guggisberg street
City Postal code Country Position/Affiliation
korle bu -accra GAR Ghana National Yaws Elimination Program Manager
Role Name Email Phone Street address
Scientific Enquiries fred binka fred.binka@gmail.com 233208131031 UGSPH, Noguchi Road
City Postal code Country Position/Affiliation
legon-accra GAR Ghana
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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