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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
Page 1
Public title:
Impact of Annual Targeted Azithromycin Treatment on Infectious Trachoma and Susceptibility to Reinfection
Update:
Reason:
ANZCTR registration title:
Impact of Annual Targeted Azithromycin Treatment on Infectious Trachoma and Susceptibility to Reinfection
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Secondary ID:
UTN:
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Trial acronym:
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Page 2
Health condition(s) or problem(s) studied:
Trachoma
Condition category:
Condition code:
Eye
Diseases / disorders of the eye
Page 3
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.
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Reason:
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.
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Control group:
Active
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Page 4
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.
Page 5
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.
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Minimum Age:
6
Months
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Maximum Age:
15
Years
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Gender:
Both males and females
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Healthy volunteers?
No
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Key exclusion criteria:
All children under six months of age.
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Page 6
Study type:
Interventional
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Purpose of the study:
Treatment
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Allocation to intervention:
Randomised controlled trial
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Describe the procedure for enrolling a subject and allocating the treatment (allocation concealment procedures):
Allocation was not concealed
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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
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Masking / blinding:
Blinded (masking used)
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Who is/are masked/blinded:
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Assignment:
Other
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Reason:
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.
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Type of endpoint(s):
Efficacy
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Page 7
Phase
Phase 4
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Anticipated or actual date of first participant enrolement:
1/11/2000
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Target sample size:
3186
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Recruitment status:
Completed
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Page 8
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
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Reason:
Name:
International Trachoma Initiative
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Address:
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Country:
United States of America
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Secondary sponsor:
Government funding body e.g. Department of Health
Name:
National Institute of Health
Address:
Country:
United States of America
Other collaborator:
Page 9
Has the study received approval from at least one ethics committee?
Yes
Update:
Reason:
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.
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Trial website:
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Page 10
Contact person for public queries
Name:
Deborah Dean
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Address:
5700 MLK Jr. Way Oakland,CA 94609
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Country:
United States of America
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Tel:
+1 510 4507655
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Fax:
+1 510 4507910
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Email:
ddean@chori.org
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Contact person for scientific queries
Name:
Deborah Dean
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Address:
5700 MLK Jr. Way Oakland,CA 94609
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Country:
United States of America
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Tel:
+1 510 4507655
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Fax:
+1 510 4507910
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Email:
ddean@chori.org
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