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.: PACTR201211000437277 Date of Approval: 18/10/2012
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Evaluation of Effect of Stopping Mass Azithromycin Treatment after five years
Official scientific title Evaluation of Effect of Stopping Mass Azithromycin Treatment after five years: a cluster randomized trial
Brief summary describing the background and objectives of the trial The GET 2020 Alliance aims to eliminate blinding trachoma by the 2020. In districts where the prevalence of the trachoma indicator trachomatous inflammation-follicular (TF) is ¿ 10% in children ages 1-9 years, the entire population is treated yearly with azithromycin as part of the WHO-endorsed SAFE strategy for trachoma control. Where baseline prevalence of TF is very high, studies have shown that the prevalence of TF remains high even after multiple years of treatment; lab tests in these areas show that the prevalence of infection with Chlamydia trachomatis is very low, indicating that few people may be benefiting from subsequent treatment with azithromycin. This study aims to monitor TF and infection prevalence in districts that have received at least 5 annual rounds of treatment with azithromycin.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) ESMAT Trial
Disease(s) or condition(s) being studied Eye Diseases,Trachoma
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/11/2012
Actual trial start date
Anticipated date of last follow up 29/05/2015
Actual Last follow-up date
Anticipated target sample size (number of participants) 27
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
Emory University IRB #60625
60625 Emory University IRB
Emory University IRB #60625
Emory University IRB #60625
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 Districts were randomized to one of two study arms using block randomization with a block size of 2 Allocation of districts to arms will be undertaken by an independent epidemiologist using block randomization to ensure a blanced number of districts across the two trial arms a block size of two was used. Open-label(Masking Not Used)
Parallel: different groups receive different interventions at same time during study Randomised Districts were randomized to one of two study arms using block randomization with a block size of 2 Allocation of districts to arms will be undertaken by an independent epidemiologist using block randomization to ensure a blanced number of districts across the two trial arms a block size of two was used. Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group S, F & E arm Districts randomized to this arm will receive the Surgery, Facial Cleanliness/Health Education and Environmental Improvement components of the SAFE strategy but will not receive the Antibiotic component 14
Control Group Control Full SAFE trachoma strategy as per WHO guidelines 13 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All districts in West Amhara that have completed five or more annual rounds of MDA with azithromycin and have been surveyed for impact will be eligible for inclusion into the study. Districts where SAFE has been implemented for less than 5 years or where impact evaluations have showed prevalence of TF in children 1-9 years to be below 10% will not be included into the study. In the excluded districts, the SAFE strategy will be continued as per the WHO standards and national guidelines. 1 Year(s) 99 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 04/10/2012 Emory University IRB
Ethics Committee Address
Street address City Postal code Country
1599 Clifton Road, 5th Floor Atlanta 30322 United States of America
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Prevalence of TF (trachomatous inflammation-follicular) in children ages 1-9 years May 2013 May 2014 May 2015
Primary Outcome ¿ Prevalence of ocular Chlamydia infection in children aged 1-9 years May 2013 May 2014 May 2015
Primary Outcome ¿ Prevalence of TS in people aged 15 years and abov May 2013 May 2014 May 2015
Secondary Outcome ¿ Prevalence of TI in children aged 1-9 years May 2013 May 2014 May 2015
Secondary Outcome ¿ Prevalence of clean faces in children aged 1-9 years May 2013 May 2014 May 2015
Secondary Outcome ¿ Prevalence of TS in people aged below 15 years May 2013 May 2014 May 2015
Secondary Outcome ¿ Uptake of SAFE interventions at the individual and household level May 2013 May 2014 May 2015
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
The Carter Center Ethiopia PO Box 13373, Bole Sub-City, Kebele 05, H. No. 956 Addis Ababa Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
The Carter Center 453 Freedom Parkway Atlanta 30306 United States of America
The International Trachoma Initiative 325 Swanton Way Decatur 30030 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor The Carter Center 453 Freedom Parkway Atlanta 30306 United States of America Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
Amhara Regional Health Bureau Ethiopia
Dr Jeremiah Ngondi Dept Public Health and Primary Care, University of Cambridge, Institute of Publich Health, Robinson Way Cambridge CB2 0SR United Kingdom
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Paul Emerson pemerso@emory.edu +1 404-420-3842 1149 Ponce de Leon Avenue
City Postal code Country Position/Affiliation
Atlanta 30307 United States of America Director, Trachoma Control Program
Role Name Email Phone Street address
Public Enquiries Stephanie Palmer spalme5@emory.edu +1 404-420-3842 1149 Ponce de Leon Avenue
City Postal code Country Position/Affiliation
Atlanta 30307 United States of America Program Development Coordinator, Trachoma
Role Name Email Phone Street address
Scientific Enquiries Jeremiah Ngondi jn250@cam.ac.uk +44 11223-763-829 University of Cambridge
City Postal code Country Position/Affiliation
Cambridge United Kingdom
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information