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NCT01767506 · ClinicalTrials.gov registry record · NA
A Surveillance and Azithromycin Treatment for Newcomers and Travelers Evaluation: The ASANTE Trial
A NA study of Trachoma, sponsored by Johns Hopkins University.
- Completed
- Registry status
- NA
- Development phase
- 52
- Enrollment target
- 1
- Study location
NCT01767506 is a NA study of Trachoma that has completed, run by Johns Hopkins University. The registered enrollment target is 52 participants, below the 80,552-participant average among 4 other Trachoma trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01767506, a NA study of Trachoma, has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- NA
- Development phase
- 52 participants
- Enrollment target
- 1
- Study location
Study Summary
Infection with C. Trachomatis has decreased substantially in trachoma endemic areas following repeated annual mass drug administration (MDA) with azithromycin, although not as rapidly as anticipated. The investigators propose to conduct a clinical trial in 52 communities in Kongwa, Tanzania that on average have trachoma infection at 3.5%. The investigators plan that all communities would have annual rounds of MDA if infection is greater than 1% or follicular trachoma (TF) is 5% or more, but half would be randomized to a surveillance and treatment program to identify and treat new families and families who travel after mass treatment. Communities will have MDA stopped if infection is 1% or less, or TF is less than 5%. MDA will be reinstated if infection re-emerges to 6% or more. The proportion of communities that are able to stop mass treatment will be compared in the group of communities randomized to mass treatment plus the newcomer/traveler treatment program compared to the communities randomized to mass treatment alone after 24 months. At the recommendation of the Data Safety and Monitoring Committee in March 2015, thirty eight (38) of the 52 communities identified as being at risk of trachoma re-emergence at 18 months will be surveyed at 30 months. At risk of trachoma re-infection communities have C. trachomatis infection rates less than or equal to 1% or TF \< 5% at the time of the 18 month survey. Surveillance of communities for families that meet the newcomer or traveler status will extend 6 months beyond the 24 month survey to 30 months in the intervention communities only. A survey of sentinel children in the intervention and control communities at 30 months will be conducted to assess the level of trachoma and infection in all 38 communities at risk of trachoma re-emergence.
Conditions Studied
Interventions
- OTHER Usual care
- OTHER Surveillance and treatment with azithromycin of newcomer and traveler families
Study Locations (1)
Maryland
- Johns Hopkins University - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2013-01 |
| Est. Completion | 2016-02 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01767506
The ClinicalTrials.gov registry entry for NCT01767506 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 52 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 80,552-participant average among 4 other Trachoma trials with a reported enrollment target (100% lower). The listed sponsor is Johns Hopkins University, which has 1,448 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Trachoma appearing as the primary indexed condition, and to 2 interventions - of which Usual care is the first listed.
NCT01767506 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT01767506 about?
NCT01767506 is a clinical study titled "A Surveillance and Azithromycin Treatment for Newcomers and Travelers Evaluation: The ASANTE Trial". Infection with C. Trachomatis has decreased substantially in trachoma endemic areas following repeated annual mass drug administration (MDA) with azithromycin, although not as rapidly as anticipated. The investigators propose to conduct a clinical trial in 52 communities in Kongwa, Tanzania that on ...
What is the current status of trial NCT01767506?
This trial is currently completed. It is a NA study. The enrollment target is 52 participants. The study started on 2013-01. Estimated completion is 2016-02.
What conditions does trial NCT01767506 study?
This clinical trial studies the following conditions: Trachoma.
What interventions are being tested in trial NCT01767506?
The interventions under investigation include: Usual care (OTHER), Surveillance and treatment with azithromycin of newcomer and traveler families (OTHER).
Who is sponsoring clinical trial NCT01767506?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01767506 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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