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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.: PACTR201306000520103 Date registered: 2013/03/13
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
Purpose of the trial Treatment
Anticipated trial start date 2011-02-28
Actual trial start date 2011-05-25
Anticipated date of last follow up 2012-12-31
Actual date of last follow up 2012-12-31
Anticipated target sample size (number of participants) 420   
Actual target sample size (number of participants) 403   
Recruitment status Completed: recruitment & data analysis complete
Secondary Ids Issuing authority/Trial register Links to Secondary ID

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

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

ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Min age Max 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 15 Years 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 2011/02/11 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 2011/02/11 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
Primary Sponsor University Of Ghana School Of Public Health Noguchi Road Legon -Accra GAR Ghana University
Secondary Sponsor Greater Accra Regional Health Directorate Workers College Road Accra GAR Ghana Company

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 Fax
Principal Investigator Dr cynthia Kwakye cindykwakye@yahoo.com 233244121272
Street address City Postal code Country Position / Affiliation
29 martey tsuru street east airport-accra GAR Ghana Deputy Director of Health
Role Name Email Phone Fax
Public Enquiries Dr Patrick Nsiiri Agana agana.nsiire@gmail.com 233 244 292170
Street address City Postal code Country Position / Affiliation
Court 6, block b2, Guggisberg street korle bu -accra GAR Ghana National Yaws Elimination Program Manager
Role Name Email Phone Fax
Scientific Enquiries Prof fred binka fred.binka@gmail.com 233208131031
Street address City Postal code Country Position / Affiliation
UGSPH, Noguchi Road legon-accra GAR Ghana