A Surveillance and Azithromycin Treatment for Newcomers and Travelers Evaluation: The ASANTE Trial
Information source: Johns Hopkins University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Trachoma
Intervention: Surveillance and treatment with azithromycin of newcomer and traveler families (Other)
Phase: Phase 4
Status: Recruiting
Sponsored by: Johns Hopkins University Official(s) and/or principal investigator(s): Sheila K West, PhD, Principal Investigator, Affiliation: Johns Hopkins University
Overall contact: Sheila K West, PhD, Phone: 410-955-2606, Email: shwest@jhmi.edu
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.
Clinical Details
Official title: A Surveillance and Azithromycin Treatment for Newcomers and Travelers Evaluation: The ASANTE Trial
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: The proportion of communities with C. trachomatis infection prevalence of 1% or below
Secondary outcome: The proportion of communities with clinical trachoma prevalence of 5% or belowThe trajectory of change in prevalence of infection with C. trachomatis and clinical trachoma The community prevalence of new infections of C. trachomatis and clinical trachoma identified The presence of active trachoma in children The presence of trachomatous scarring in women
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
Census and Mass Drug Administration (MDA): All persons residing in the 52 study
communities will be eligible for both the census and the annual mass azithromycin
administrations.
Intervention: In the 26 intervention communities, active surveillance for new families and
returning travelers will be undertaken, and those meeting the criteria below will be
eligible for family treatment with azithromycin if:
Families are "newcomers" and
- They have children under 10 years of age
- They have moved into a new house in the community or into an existing household
- They plan to reside for at least 1 month in the study community and
- They have moved from a community that has not had an MDA in the last year
Families are classified as having traveled and
- They have children under 10 years of age
- They participated in a previous census in the same community
- They left the community for at least 8 weeks (2 months) for an area that has not
received MDA in the past year and at least one child has returned and
- They have returned to reside in the community for at least 2 months
Sentinel Children: In all 52 communities, samples of 135 children will be selected from
the community census lists every six months for survey and examination.
These children:
- must be between 1 year and 9. 9 years of age,
- must be a resident in the community and not a short-term (less than 2 months)
visitor,
- must not have an ocular condition that would preclude grading trachoma or taking an
ocular specimen,
- must be willing to have a swab taken as part of being a sentinel child (this is
critical, as each swab result counts towards the criteria for stopping MDA), and
- must have an identifiable guardian capable of providing consent to participate.
Adult Women: In all 52 communities, samples of 100 women will be selected from the
baseline community census list.
These women:
- must be aged 15 years and over
- must be a resident in the community and not a short term (less than 2 months) visitor
- must not have an ocular condition that precludes grading of scarring on upper
conjunctiva
- must be able to provide informed consent.
Exclusion Criteria:
- none
Locations and Contacts
Sheila K West, PhD, Phone: 410-955-2606, Email: shwest@jhmi.edu
Johns Hopkins University, Baltimore, Maryland 21205, United States; Recruiting Sheila K West, PhD, Phone: 410-955-2606, Email: shwest@jhmi.edu Sheila K West, PhD, Principal Investigator
Additional Information
Starting date: January 2013
Last updated: February 10, 2015
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