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A Surveillance and Azithromycin Treatment for Newcomers and Travelers Evaluation: The ASANTE Trial
NCT01767506 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 52 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Johns Hopkins University, which has 1,517 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01767506 reports 1 study location spanning 1 distinct geographic area — top geographies include Maryland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01767506?
This trial is sponsored by Johns Hopkins University, which has 1,517 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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