None listed
Conditions
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.
Interventions
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/k
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.
Sponsors
International Trachoma Initiative
Study design
Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
6 Months to 15 Years
Healthy volunteers
No
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.
Exclusion criteria
All children under six months of age.
Outcome results
None listed