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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 below

The 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

Page last updated: August 23, 2015

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