A Surveillance and Azithromycin Treatment for Newcomers and Travelers Evaluation: The ASANTE Trial - Full Text View

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%, but half would be randomized to a surveillance and treatment program to identify and treat new families and families who travel after mass treatment. 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:

Drug Information available for: Azithromycin Azithromycin dihydrate Azithromycin monohydrate

U.S. FDA Resources

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:	43500
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%. 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%.	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 from a community that has not had an MDA in the last year and
They plan to reside for at least 2 months in our study community

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 for an area that has not received MDA in the past year and
They have returned to reside in the community for at least 2 months

Sentinel Children: In all 52 communities, samples of 100 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

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

Contacts

Contact: Sheila K West, PhD	410-955-2606	shwest@jhmi.edu
Contact: Jennifer Lee, MSPH	410-502-9810	jlee@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

National Eye Institute (NEI)

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 15, 2013
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
Azithromycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013