A Surveillance and Azithromycin Treatment for Newcomers and Travelers Evaluation: The ASANTE Trial

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Brief Title

A Surveillance and Azithromycin Treatment for Newcomers and Travelers Evaluation: The ASANTE Trial

Official Title

A Surveillance and Azithromycin Treatment for Newcomers and Travelers Evaluation: The ASANTE Trial

Brief 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.
    



Study Type

Interventional


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

Condition

Trachoma

Intervention

Surveillance and treatment with azithromycin of newcomer and traveler families

Study Arms / Comparison Groups

 Intervention
Description:  Communities will receive usual care, including annual mass drug administration with azithromycin if trachoma infection level is greater than 1% or TF is 5% or more. 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. In addition, surveillance and treatment with azithromycin of newcomer and traveler families within 2 weeks of arrival to or return to the community.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

52

Start Date

January 2013

Completion Date

February 2016

Primary Completion Date

December 2015

Eligibility 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
      

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Sheila K West, PhD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01767506

Organization ID

NA_00076305

Secondary IDs

U10EY022584

Responsible Party

Sponsor

Study Sponsor

Johns Hopkins University

Collaborators

 National Eye Institute (NEI)

Study Sponsor

Sheila K West, PhD, Principal Investigator, Johns Hopkins University


Verification Date

October 2017