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

This study is currently recruiting participants. (see Contacts and Locations)
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
  Purpose

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.


Condition Intervention Phase
Trachoma
Other: Surveillance and treatment with azithromycin of newcomer and traveler families
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Surveillance and Azithromycin Treatment for Newcomers and Travelers Evaluation: The ASANTE Trial

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 52
Study Start Date: January 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
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.
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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01767506

Contacts
Contact: Sheila K West, PhD 410-955-2606 shwest@jhmi.edu
Contact: Doug Richesson, MPH 410-502-9810 driches1@jhmi.edu

Locations
United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21205
Contact: Sheila K West, PhD    410-955-2606    shwest@jhmi.edu   
Principal Investigator: Sheila K West, PhD         
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Sheila K West, PhD Johns Hopkins University
  More Information

No publications provided

Responsible Party: Sheila K West, Principal Investigator, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01767506     History of Changes
Other Study ID Numbers: NA_00076305, U10EY022584
Study First Received: January 9, 2013
Last Updated: February 25, 2014
Health Authority: United States: Institutional Review Board
Tanzania: National Institute for Medical Research

Keywords provided by Johns Hopkins University:
Trachoma
Azithromycin
Mass treatment

Additional relevant MeSH terms:
Chlamydia Infections
Trachoma
Conjunctivitis, Bacterial
Eye Infections, Bacterial
Bacterial Infections
Chlamydiaceae Infections
Gram-Negative Bacterial Infections
Eye Infections
Infection
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Corneal Diseases

ClinicalTrials.gov processed this record on September 15, 2014