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

This study is currently recruiting participants.
Verified February 2014 by Johns Hopkins University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Sheila K West, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01767506
First received: January 9, 2013
Last updated: February 25, 2014
Last verified: February 2014

January 9, 2013
February 25, 2014
January 2013
December 2015   (final data collection date for primary outcome measure)
The proportion of communities with C. trachomatis infection prevalence of 1% or below [ Time Frame: 24 months ] [ Designated as safety issue: No ]
The proportion of communities with C. trachomatis infection prevalence at 1% or below in children ages 1 to 9 years at the 24-month survey, comparing the intervention arm to the usual practice arm
Same as current
Complete list of historical versions of study NCT01767506 on ClinicalTrials.gov Archive Site
  • The proportion of communities with clinical trachoma prevalence of 5% or below [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    The proportion of communities with clinical trachoma prevalence of 5% or below in children ages 1 to 9 years at the 24-month survey, comparing the intervention arm to the usual practice arm
  • The trajectory of change in prevalence of infection with C. trachomatis and clinical trachoma [ Time Frame: Baseline to 24 months ] [ Designated as safety issue: No ]
    Model the change in prevalence of C. trachomatis infection and clinical trachoma in communities in the usual practice arm with continued rounds of (and stopping of) mass drug administration (MDA) over the 24-month trial
  • The community prevalence of new infections of C. trachomatis and clinical trachoma identified [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Model the risk of re-emergent infection and trachoma in the communities which have stopped MDA at the outset and over the course of the 24-month trial
  • The presence of active trachoma in children [ Time Frame: Baseline only ] [ Designated as safety issue: No ]
    Model the risk of active trachoma in children related to exposure to indoor cooking fires
  • The presence of trachomatous scarring in women [ Time Frame: Baseline only ] [ Designated as safety issue: No ]
    Model the risk of trachomatous scarring in adult women related to exposure to indoor cooking fires
Same as current
Not Provided
Not Provided
 
A Surveillance and Azithromycin Treatment for Newcomers and Travelers Evaluation: The ASANTE Trial
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 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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Trachoma
Other: Surveillance and treatment with azithromycin of newcomer and traveler families
The intervention is a surveillance for newcomers and travelers in communities, and provision of azithromycin to them at the time of arrival, in advance of scheduled mass drug administration
Other Name: Zithromax
  • Experimental: Intervention
    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.
    Intervention: Other: Surveillance and treatment with azithromycin of newcomer and traveler families
  • Active Comparator: Usual Care
    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.
    Intervention: Other: Surveillance and treatment with azithromycin of newcomer and traveler families
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
52
December 2015
December 2015   (final data collection date for primary outcome measure)

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
Both
Not Provided
Yes
Contact: Sheila K West, PhD 410-955-2606 shwest@jhmi.edu
Contact: Doug Richesson, MPH 410-502-9810 driches1@jhmi.edu
United States
 
NCT01767506
NA_00076305, U10EY022584
Yes
Sheila K West, Johns Hopkins University
Johns Hopkins University
National Eye Institute (NEI)
Principal Investigator: Sheila K West, PhD Johns Hopkins University
Johns Hopkins University
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP