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ANZCTR Newsletter Issue 5, Dec 2009 National and multinational prospective trial registers - The Lancet commentary En route to international clinical trial transparency - The Lancet commentary Declaration of Helsinki now has trial registration requirement (paragraph 19) The 2007 National Health and Medical Research Council (NHMRC) revised National Statement on Ethical Conduct in Human Research includes clause regarding trial registration (page 36, section 3.3.12) The 2007 NHMRC Australian Code for the Responsible Conduct of Research includes a clause regarding trial registration (section 4.10). This Code applies to all NHMRC funded trials The National Ethics Application Form (NEAF) now includes a question regarding details of trial registration (Question 9.1.8.4) ICMJE expands scope of registration ANZCTR is one of the first Primary Registers in the WHO Register Network (Search Portal)
ANZCTR User Survey ANZCTR Statistics International Committee of Medical Journal Editors (ICMJE): June 2007 editorial International Committee of Medical Journal Editors (ICMJE): May 2005 editorial WHO International Clinical Trials Registry Platform (ICTRP) The World Health Organization announces new standards for registration of all human medical research WHO trial registration data set NHMRC Clinical Trials Centre National Health and Medical Research Council (NHMRC) information about the ANZCTR Frequently Asked Questions about the ANZCTR About the ANZCTR How to register a trial How to update a trial

Trial Details
indicate updates made to monitored data item(s) since trial registration. These data item(s) are monitored to ensure they comply with the WHO / journal editors standards.
 
Request Number: 081543
ACTR Number: ACTRN12606000360516
Trial Status: Registered
Date Submitted: 16/08/2006
Date Registered: 18/08/2006

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Public title: Impact of Annual Targeted Azithromycin Treatment on Infectious Trachoma and Susceptibility to Reinfection
ANZCTR registration title: Impact of Annual Targeted Azithromycin Treatment on Infectious Trachoma and Susceptibility to Reinfection
Secondary ID: 
UTN:
Trial acronym:

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Health condition(s) or problem(s) studied:
Trachoma 
Condition category: Condition code:
Eye Diseases / disorders of the eye 

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Description of intervention(s) / exposure: Intervention:household targeted once a year single dose azithromycin treatment. 2. Intervention group(s): SAFE and SA-only communes that received targeted azithromycin treatment at baseline and 12 months. 3. Duration of the intervention: A single oral dose azithromycin (20 mg/kg to children, 1 g for adults, pregnant females received erythromycin) was given to all index cases and their household members at baseline and 12 months in the SAFE and SA-only communes. A single oral dose of 20 mg/kg of azithromycin was administered to children while adults received 1 g. Pregnant females received oral erythromycin ( 250mg PO qid for 4 weeks). These two oral antibiotics were given only at baseline and 12-months. 1% Topical tetracycline (0.5-inch ribbon of tetracycline ophthalmic ointment in both eyes bid for 6 weeks) was given to all individuals with active trachoma (TF, TI or both) in all communes at each time point (at baseline and at 6, 12, 18, 24 and 36 months follow up time points) except for index cases and their household members who were treated with azithromycin. Index cases were school children aged 5-15 years who had active trachoma defined as TF, TI or both TF and TI.
Intervention code:Treatment: drugs 
Comparator / control treatment: 1. Control group: The S-only (the S stands for Surgery) commune was the control group where cases with trichiasis (TT) were identified and informed of the availability of surgery to correct TT. Targeted azithromycin treatment was not applied in this commune. However, topical tetracycline applied ocularly was given to individuals who had active trachoma [defined as trachomatous follicles (TF), inflammatory trachoma (TI) or both] and also to individuals with active trachoma in the SAFE and SA-only (the S stands for surgery and the A stands for antibiotics) communes if an individual with active trachoma was not in a household with an index case. Index cases were defined as school children aged 5-15 years who had active trachoma (defined as TF, TI or both TF and TI) and were treated with azithromicyn along with their household members. SAFE refers to the World Health Organization SAFE program that includes Surgery for trichiasis; Antibiotics for Chlamydia trachomatis infection; Facial cleanliness; and Environmental improvement.
Control group: Active

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Primary outcome:Active trachoma and Chlamydia trachomatis infection of the external eye. 
Timepoint:Time points of the study were at baseline and at 6, 12, 18, 24 and 36 months; baseline and 12 months were the time points where index cases and their household members in the SAFE and SA-only communes received azithromycin. Thus, the follow up is 2 years beyond the second treatment with azithromycin. 
Secondary outcome:New infection, continuing infection and reinfection. 
Timepoint:At 6, 12, 18, 24, and 36 months. 

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Key inclusion criteria: 1) all individuals in the SAFE, SA-only, and S-only communes were included in the study unless they were 6 months of age or younger; 2) For single dose oral azithromycin treatment at baseline and 12 months, school children aged 5-15 years who had active trachoma (defined as index case) and all members of their households regardless of active trachoma status were included for treatment in the SAFE and SA-only communes; 3) all other individuals in the SAFE, SA-only and S-only communes not in a household with an index case were included and were eligible for treatment with topical tetracycline if they had active trachoma.
Minimum Age: 6 Months
Maximum Age: 15 Years
Gender: Both males and females
Healthy volunteers? No
Key exclusion criteria: All children under six months of age.

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Study type: Interventional
Purpose of the study: Treatment
Allocation to intervention: Randomised controlled trial
Describe the procedure for enrolling a subject and allocating the treatment (allocation concealment procedures): Allocation was not concealed
Describe the methods used to generate the sequence in which subjects will be randomised (sequence generation): Simple randomization by using procedures such as coin-tossing and dice-rolling
Masking / blinding: Blinded (masking used)
Who is/are masked/blinded: The people administering the treatment/s
 The people assessing the outcomes
 The people analysing the results/data
Assignment: Other
Other design features (specify): The other assignment was topical tetracycline treatment of individuals who had active trachoma. Inclusion criteria for topical tetracycline treatment: 1) Living in S-only commune and having active trachoma at any time point of the study; 2) if living in SAFE and SA-only commune, individuals with active trachoma who were not living in a household with an index case.Exclusion criteria: Children under six months of age. Individuals in the SAFE, SA-only and S-only communes did not know their active disease status or their infection status;Ophthalmologists who graded villagers for trachoma were blinded as to the subjects’s infection status;The lab technician who tested cases for infection by PCR (Amplicor) was blinded as to the villagers’ active disease and treatment status;Data analyst was blinded as to the villagers’ treatment status, active disease and infection status and to the commune type.
Type of endpoint(s): Efficacy

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Phase Phase 4
Anticipated or actual start date: 1/11/2000
Target sample size: 3186
Recruitment status: Completed

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Funding source:Government funding body e.g. Australian Research Council 
Name:National Institute of Health 
Address: 
Country:United States of America 
Primary sponsor: Charities/Societies/Foundations
Name: International Trachoma Initiative
Address:
Country: United States of America
Secondary sponsor:Government funding body e.g. Department of Health 
Name:National Institute of Health 
Address: 
Country:United States of America 
Other collaborator: 

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Has the study received approval from at least one ethics committee? Yes
Ethics Committee name 1:he Institutional Review Board of Children's Hospital and Research Center at Oakland 
Address: 
Country:New Zealand 
Date of approval: 
HREC Number:2002-18 
Ethics Committee name 2:the Vietnamese Ministry of Health, National Institute of Ophthalmology 
Address: 
Country:Viet Nam 
Date of approval: 
HREC Number:2002-18 
Countries of recruitment:Outside Australia 
United States of America 
Brief summary: The World Health Organization developed the SAFE strategy [Surgery for trichiasis; Antibiotics for Chlamydia trachomatis infection; Facial cleanliness; and Environmental improvement] to eliminate blinding trachoma globally by the year 2020.
Objective of the study was to evaluate the impact of two annual targeted azithromycin treatments on active trachoma and Chlamydia trachomatis infection rates over three years in Vietnam. Three communes were randomly selected for a longitudinal study in Vietnam. Individuals were graded for trachoma followed by conjunctival sampling to detect chlamydiae by commercial polymerase chain reaction (PCR). Grading and chlamydial detection were repeated every six months for three years.
Azithromycin was given to school-age children from 5 to 15 years of age with active trachoma and their household members in SAFE and SA-only communes at baseline and 12 months and were compared with an S-only control commune that did not receive azithromcyin. Topical tetracycline was given to all patients with active trachoma (TF, TI or TF/TI) in all communes at each time point. Main outcomes were prevalence and incidence of active trachoma and C. trachomatis infection in all communes at baseline, 6, 12, 18, 24, and 36 months.
Trial website:
Presentations / publication list:

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Contact person for public queries
Name: Deborah Dean
Address: 5700 MLK Jr. Way Oakland,CA 94609
Country: United States of America
Tel: +1 510 4507655
Fax: +1 510 4507910
Email: ddean@chori.org

Contact person for scientific queries
Name: Deborah Dean
Address: 5700 MLK Jr. Way Oakland,CA 94609
Country: United States of America
Tel: +1 510 4507655
Fax: +1 510 4507910
Email: ddean@chori.org

Contact person responsible for updating information
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