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Trial registered on ANZCTR


Registration number
ACTRN12606000360516
Ethics application status
Approved
Date submitted
16/08/2006
Date registered
18/08/2006
Date last updated
18/08/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
Impact of Annual Targeted Azithromycin Treatment on Infectious Trachoma and Susceptibility to Reinfection
Scientific title
Impact of Annual Targeted Azithromycin Treatment on Infectious Trachoma and Susceptibility to Reinfection
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Trachoma 1329 0
Condition category
Condition code
Eye 1417 1417 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
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 [1] 1310 0
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

Outcomes
Primary outcome [1] 1938 0
Active trachoma and Chlamydia trachomatis infection of the external eye.
Timepoint [1] 1938 0
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 [1] 3399 0
New infection, continuing infection and reinfection.
Timepoint [1] 3399 0
At 6, 12, 18, 24, and 36 months.

Eligibility
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
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
All children under six months of age.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation was not concealed
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?



Intervention assignment
Other
Other design features
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.
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/11/2000
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
3186
Accrual to date
Final
Recruitment outside Australia
Country [1] 388 0
United States of America
State/province [1] 388 0

Funding & Sponsors
Funding source category [1] 1549 0
Government body
Name [1] 1549 0
National Institute of Health
Country [1] 1549 0
United States of America
Primary sponsor type
Charities/Societies/Foundations
Name
International Trachoma Initiative
Address
Country
United States of America
Secondary sponsor category [1] 1362 0
Government body
Name [1] 1362 0
National Institute of Health
Address [1] 1362 0
Country [1] 1362 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2978 0
he Institutional Review Board of Children's Hospital and Research Center at Oakland
Ethics committee address [1] 2978 0
Ethics committee country [1] 2978 0
New Zealand
Date submitted for ethics approval [1] 2978 0
Approval date [1] 2978 0
Ethics approval number [1] 2978 0
2002-18
Ethics committee name [2] 2979 0
the Vietnamese Ministry of Health, National Institute of Ophthalmology
Ethics committee address [2] 2979 0
Ethics committee country [2] 2979 0
Viet Nam
Date submitted for ethics approval [2] 2979 0
Approval date [2] 2979 0
Ethics approval number [2] 2979 0
2002-18

Summary
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
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27917 0
Address 27917 0
Country 27917 0
Phone 27917 0
Fax 27917 0
Email 27917 0
Contact person for public queries
Name 10499 0
Deborah Dean
Address 10499 0
5700 MLK Jr. Way
Oakland,CA
94609
Country 10499 0
United States of America
Phone 10499 0
+1 510 4507655
Fax 10499 0
+1 510 4507910
Email 10499 0
[email protected]
Contact person for scientific queries
Name 1427 0
Deborah Dean
Address 1427 0
5700 MLK Jr. Way
Oakland,CA
94609
Country 1427 0
United States of America
Phone 1427 0
+1 510 4507655
Fax 1427 0
+1 510 4507910
Email 1427 0
[email protected]

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