Kebele Elimination of Trachoma for Ocular Health

Study Overview
=================
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.

Official Title
-----------------
Kebele Elimination of Trachoma for Ocular Health

Conditions
-----------------
Trachoma

Intervention / Treatment
-----------------
* Drug: Azithromycin


Participation Criteria
=================
Eligibility Criteria
-----------------
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.
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: WHO-recommended<br>Annual mass azithromycin distribution of all residents | Drug: Azithromycin<br>* Mass Drug Administration<br>* Other names: Zithromax;|
| Experimental: Age-based core group<br>Annual mass azithromycin treatment of everyone plus quarterly treatment of children | Drug: Azithromycin<br>* Mass Drug Administration<br>* Other names: Zithromax;|
| Experimental: PCR infection-based core group<br>Annual mass azithromycin treatment plus quarterly treatment of a PCR-based cohort that would be a subset of the age-based core group. | Drug: Azithromycin<br>* Mass Drug Administration<br>* Other names: Zithromax;|
| Experimental: TI-based core group<br>Annual mass azithromycin treatment plus quarterly treatment of a conjunctival photography-based cohort that would be a subset of the age-based core group | Drug: Azithromycin<br>* Mass Drug Administration<br>* Other names: Zithromax;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular chlamydia measured in a population based age-stratified sample of the entire community | Assessed by PCR | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infectious load of chlamydia among 0-9 year-old children infected with ocular chlamydia | Assessed by PCR | 36 months | 
| Conjunctival inflammation | Assessed from conjunctival photography | 36 months | 
| Seropositivity to C. trachomatis antibodies CT694 and Pgp3 | Assessed via ELISA on elute from dried blood spots | 36 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Azithromycin, Mass Drug Administration, Antibiotic Resistance