Trachoma
Conditions
Keywords
Azithromycin, Mass Drug Administration, Antibiotic Resistance
Brief summary
The investigators propose a cluster-randomized clinical trial to determine whether an intensive, targeted azithromycin distribution strategy is effective for elimination of trachoma at the kebele level compared to the World Health Organization (WHO) recommendation of annual azithromycin distribution.
Detailed description
The investigators propose to randomize at the kebele level, which consist of approximately 15 villages, 4,000 residents, and are served by a single primary school. Eighty kebeles will be randomized to one of four arms: 1) annual mass azithromycin distribution per WHO guidelines (Annual); 2) annual mass azithromycin distribution plus quarterly targeted treatment of all children aged 0-9 years (Core Group-Age); 3) annual mass azithromycin distribution plus quarterly targeted treatment of all children aged 0-9 years with a positive chlamydial PCR test (Core Group-PCR); or 4) annual mass azithromycin distribution plus quarterly targeted treatment of all children aged 0-9 years positive for conjunctival inflammation as assessed from annual photography (Core Group-TI). The primary outcome for the trial will be the ocular chlamydia prevalence at 12, 24, and 36 months. Secondary outcomes will include bacterial load of ocular chlamydia via quantitative PCR, the prevalence of clinically active trachoma assessed at 12, 24, and 36 months, and serology via dried blood spot at baseline and 36 months.
Interventions
Mass Drug Administration
Sponsors
Study design
Eligibility
Inclusion criteria
* All individuals in all communities will be eligible for annual mass azithromycin distribution per WHO guidelines.
Exclusion criteria
* Those who do not consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ocular chlamydia measured in a population based age-stratified sample of the entire community | 36 months | Assessed by PCR |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Infectious load of chlamydia among 0-9 year-old children infected with ocular chlamydia | 36 months | Assessed by PCR |
| Conjunctival inflammation | 36 months | Assessed from conjunctival photography |
Countries
Ethiopia, United States