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| ID | Type | Description | Link |
|---|---|---|---|
| 1UG1EY028088 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Eye Institute (NEI) | NIH |
| Eyu-Ethiopia | UNKNOWN |
| Bahir Dar University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| WHO-recommended | Active Comparator | Annual mass azithromycin distribution of all residents |
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| Age-based core group | Experimental | Annual mass azithromycin treatment of everyone plus quarterly treatment of children |
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| PCR infection-based core group | Experimental | Annual mass azithromycin treatment plus quarterly treatment of a PCR-based cohort that would be a subset of the age-based core group. |
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| TI-based core group | Experimental | Annual mass azithromycin treatment plus quarterly treatment of a conjunctival photography-based cohort that would be a subset of the age-based core group |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Azithromycin | Drug | Mass Drug Administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ocular chlamydia measured in a population based age-stratified sample of the entire community | Assessed by PCR | 36 months |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tom M Lietman, MD | University of California, San Francisco | Principal Investigator |
| Hadley Burroughs, MSPH | University of California, San Francisco | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSF Proctor Foundation | San Francisco | California | 94143 | United States | ||
| Eyu-Ethiopia |
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| ID | Term |
|---|---|
| D014141 | Trachoma |
| ID | Term |
|---|---|
| D003234 | Conjunctivitis, Bacterial |
| D015818 | Eye Infections, Bacterial |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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| ID | Term |
|---|---|
| D017963 | Azithromycin |
| ID | Term |
|---|---|
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 |
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|
| 36 months |
| Bahir Dar |
| Ethiopia |
| D007239 | Infections |
| D002690 | Chlamydia Infections |
| D002694 | Chlamydiaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D015817 | Eye Infections |
| D003231 | Conjunctivitis |
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |
| D003316 | Corneal Diseases |
| Organic Chemicals |