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| ID | Type | Description | Link |
|---|---|---|---|
| 5UG1EY030833 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Programme National de Santé Oculaire (PNSO) | UNKNOWN |
| 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 Maradi, Niger. 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). |
|
| 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. |
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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 |
| Tom 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 |
|---|---|---|---|---|---|---|
| Programme National de Santé Oculaire (PNSO) | Niamey | Niger |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33407263 | Derived | Amza A, Kadri B, Nassirou B, Arzika AM, Austin A, Nyatigo F, Lebas E, Arnold BF, Lietman TM, Oldenburg CE. Azithromycin Reduction to Reach Elimination of Trachoma (ARRET): study protocol for a cluster randomized trial of stopping mass azithromycin distribution for trachoma. BMC Ophthalmol. 2021 Jan 6;21(1):15. doi: 10.1186/s12886-020-01776-4. |
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Communities (grappes) were randomized as the unit of allocation. Monitoring surveys for outcome assessment enrolled children residing in study communities; adults were not enrolled as study participants for outcome assessment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Azithromycin Continuation | 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). Azithromycin: 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. |
| FG001 | Azithromycin Discontinuation | In study communities randomized to the Azithromycin Discontinuation arm, individuals will receive no treatment. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline Survey |
| |||||||||||||
| 36 Months Survey |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Azithromycin Continuation | 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). Azithromycin: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Ocular Chlamydia Measured in a Population-based Sample of 0-9 Year-old Children | Assessed by PCR | This is a cluster-randomized trial wit cross-sectional data collection at baseline and endline. Participant Flow reflects counts of clusters and enrolled children, not the analytic dataset. The number analyzed includes all eligible individuals captured in the cross-sectional villages, which may exceed the number 'Started' in Participant Flow. | Posted | Count of Participants | Participants | 36 months |
|
28 days
Individuals have been given azithromycin will be told to immediately communicate side-effects to local health extension workers, who will relay the message to representatives of PNSO, which will ensure that appropriate medical care will be provided, and that the frequency and severity of adverse events can be assessed. Although azithromycin was distributed to all community members, adverse event data were systematically collected only for enrolled children participating in monitoring surveys.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Azithromycin Continuation | 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). Azithromycin: 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Thomas Lietman | UCSF FI Proctor Foundation | (415) 476-1442 | tom.lietman@ucsf.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 25, 2021 | Dec 8, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 20, 2020 | Dec 8, 2025 | SAP_001.pdf |
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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 |
| NOT COMPLETED |
|
| BG001 | Azithromycin Discontinuation | In study communities randomized to the Azithromycin Discontinuation arm, individuals will receive no treatment. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | year |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Azithromycin Discontinuation | In study communities randomized to the Azithromycin Discontinuation arm, individuals will receive no treatment. |
|
|
| Secondary | Infectious Load of Chlamydia Among 0-9 Year-old Children Infected With Ocular Chlamydia | Assessed by PCR | This is a cluster-randomized trial wit cross-sectional data collection at baseline and endline. Participant Flow reflects counts of clusters and enrolled children, not the analytic dataset. The number analyzed includes all eligible individuals captured in the cross-sectional villages, which may exceed the number 'Started' in Participant Flow. | Posted | Mean | Standard Deviation | copies/mL | 36 months |
|
|
|
| Secondary | 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. | This is a cluster-randomized trial wit cross-sectional data collection at baseline and endline. Participant Flow reflects counts of clusters and enrolled children, not the analytic dataset. The number analyzed includes all eligible individuals captured in the cross-sectional villages, which may exceed the number 'Started' in Participant Flow. | Posted | Count of Participants | Participants | 36 months |
|
|
|
| 0 |
| 1,999 |
| 0 |
| 1,999 |
| 0 |
| 1,999 |
| EG001 | Azithromycin Discontinuation | In study communities randomized to the Azithromycin Discontinuation arm, individuals will receive no treatment. | 0 | 1,981 | 0 | 1,981 | 0 | 1,981 |
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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 |