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| ID | Type | Description | Link |
|---|---|---|---|
| 5UG1EY030833 | U.S. NIH Grant/Contract | View source |
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Study withdrawn (no participants enrolled) due to resources.
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| Name | Class |
|---|---|
| Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo | OTHER |
| National Eye Institute (NEI) | NIH |
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The investigators propose a randomized controlled trial of discontinuation versus continuation of annual mass azithromycin distribution in hypoendemic communities of Maniema, DRC. The investigators will randomize communities with up to 20% Trachomatous Inflammation - Follicular (TF) prevalence following at least 5 years of mass azithromycin distribution to discontinuation or continuation of 3 additional years of annual mass azithromycin distribution.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Azithromycin Continuation | Active Comparator | In study communities randomized to the Azithromycin Continuation arm, all individuals aged 1 month and older will receive a single mass distribution of azithromycin several weeks after the baseline and 36-month monitoring visits. Oral azithromycin, 20 mg/kg for children and 1 g for adults, will be offered to all households identified on the preceding census in the communities randomized to continuing treatment. Study drug will be distributed by health extension workers and organized by PNSO. Individuals with a known macrolide allergy will be offered a two-week course of daily ophthalmic tetracycline ointment (two tubes). |
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| Azithromycin Discontinuation | No Intervention | In study communities randomized to the Azithromycin Discontinuation arm, individuals will receive no treatment. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Azithromycin | Drug | In study communities randomized to the Azithromycin Continuation arm, all individuals aged 1 month and older will receive a single mass distribution of azithromycin several weeks after the baseline and 36-month monitoring visits. In study communities randomized to Azithromycin Discontinuation, participants will receive no treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Ocular chlamydia measured in a population-based sample of 0-9 year-old children | 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. Clinical photographs of the conjunctiva will be assessed by masked graders according to the grading scale described by the WHO Simplified Grading System. The system includes five signs, each of which can be present or absent: Trachomatous inflammation - follicular Trachomatous inflammation-intense Trachomatous scarring Trachomatous trichiasis Corneal opacity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Catherine Oldenburg, ScD, MPH | University of California, San Francisco | Principal Investigator |
| Thomas Lietman, MD | University of California, San Francisco | Principal Investigator |
| Elodie Lebas, RN | University of California, San Francisco | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | Kindu | Maniema Province | Democratic Republic of the Congo |
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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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Double (Investigator, Outcomes Assessor)
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| 36 months |
| 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 |