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| ID | Type | Description | Link |
|---|---|---|---|
| K23EY019881 | U.S. NIH Grant/Contract | View source |
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Nepal Ministry of Health implemented public drug treatment prior to the proposed start date
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| Name | Class |
|---|---|
| National Eye Institute (NEI) | NIH |
The main purpose of this study is to determine if ocular Chlamydia trachomatis infection can be eliminated in communities in Nepal following mass antibiotic distributions with azithromycin. The investigators will study both clinical trachoma and ocular C. trachomatis infection. The overall objective is to determine if the current World Health Organization (WHO) treatment strategy results in elimination of trachoma and infection.
2. The investigators hypothesize that infection with C. trachomatis will be undetectable in all members within a community following mass treatment as determined by the most highly sensitive nucleic acid amplification testing available (mRNA-based APTIMA and DNA-based AMPLICOR PCR).ve nucleic acid amplification testing available (mRNA-based APTIMA and DNA-based AMPLICOR PCR).
Here we evaluate whether ocular chlamydia infection and clinical trachoma are eliminated from 24 communities in western Nepal following a mass antibiotic distribution program. It is unknown if repeated treatments should continue or can be stopped thereby minimizing side effects and the high cost of medicine distribution. The investigators plan to randomize individuals to two groups to study the effects of a mass antibiotic distribution program: 1) treatment of antibiotics and 2) delayed treatment of antibiotics (after 4-6 months).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Antibiotic | Experimental | Azithromycin, suspension (liquid), 1 gram, one-time dose |
|
| Observation | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Azithromycin | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Trachoma (clinical and C. trachomatis) | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Anthropometry (height for weight) | 12 months | |
| Malaria | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bruce D Gaynor, MD | UCSF F. I. Proctor Foundation (California, USA) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Geta Eye Hospital | Geṭā | Kailali | 10900 | Nepal |
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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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| 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 |