search
Back to results

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

Primary Purpose

Trachoma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Surveillance and treatment with azithromycin of newcomer and traveler families
Usual care
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Trachoma focused on measuring Trachoma, Azithromycin, Mass treatment

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Johns Hopkins University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention

Usual Care

Arm 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.

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.

Outcomes

Primary Outcome Measures

The Proportion of Communities With C. Trachomatis Infection Prevalence of 1% or Below
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
The Mean of the Prevalence of Active Trachoma (TF) in Communities in Both Arms.
Model the risk of active trachoma in intervention and control communities. We used the mean % and 95 % confidence interval as they present for a variable to describe the center of the population the sample represents and the precision of the estimate of that center. If the variable is normally distributed in the population, the probability is 95% that the true mean falls in the 95% confidence interval.

Full Information

First Posted
January 9, 2013
Last Updated
October 6, 2017
Sponsor
Johns Hopkins University
Collaborators
National Eye Institute (NEI)
search

1. Study Identification

Unique Protocol Identification Number
NCT01767506
Brief Title
A Surveillance and Azithromycin Treatment for Newcomers and Travelers Evaluation: The ASANTE Trial
Acronym
ASANTE
Official Title
A Surveillance and Azithromycin Treatment for Newcomers and Travelers Evaluation: The ASANTE Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
National Eye Institute (NEI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trachoma
Keywords
Trachoma, Azithromycin, Mass treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm 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.
Arm Title
Usual Care
Arm Type
Active Comparator
Arm 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.
Intervention Type
Other
Intervention Name(s)
Surveillance and treatment with azithromycin of newcomer and traveler families
Other Intervention Name(s)
Zithromax
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Usual care
Other Intervention Name(s)
Zithromax
Intervention Description
Scheduled mass drug administration (MDA) of 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.
Primary Outcome Measure Information:
Title
The Proportion of Communities With C. Trachomatis Infection Prevalence of 1% or Below
Description
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
Time Frame
24 months
Secondary Outcome Measure Information:
Title
The Proportion of Communities With Clinical Trachoma Prevalence of 5% or Below
Time Frame
24 months
Title
The Mean of the Prevalence of Active Trachoma (TF) in Communities in Both Arms.
Description
Model the risk of active trachoma in intervention and control communities. We used the mean % and 95 % confidence interval as they present for a variable to describe the center of the population the sample represents and the precision of the estimate of that center. If the variable is normally distributed in the population, the probability is 95% that the true mean falls in the 95% confidence interval.
Time Frame
Baseline only

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sheila K West, PhD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
28662043
Citation
West SK, Munoz B, Mkocha H, Dize L, Gaydos CA, Swenor B, Ervin AM, Quinn TC. Treating village newcomers and travelers for trachoma: Results from ASANTE cluster randomized trial. PLoS One. 2017 Jun 29;12(6):e0178595. doi: 10.1371/journal.pone.0178595. eCollection 2017.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs