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

NCT01767506 | Completed Results DMC

• 2 other identifiers: NA_00076305U10EY022584
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Trachoma

Keywords

Trachoma; Azithromycin; Mass treatment

Outcome Measures

Primary Outcomes (1)

• 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

  24 months

Secondary Outcomes (2)

• The Proportion of Communities With Clinical Trachoma Prevalence of 5% or Below

  24 months

• The Mean of the Prevalence of Active Trachoma (TF) in Communities in Both Arms.

  Baseline only

Study Arms (2)

Intervention

EXPERIMENTAL

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; Other: Usual care

Usual Care

ACTIVE COMPARATOR

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: Usual care

Interventions

Surveillance and treatment with azithromycin of newcomer and traveler families OTHER

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

Also known as: Zithromax

Intervention

Usual care OTHER

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.

Also known as: Zithromax

Intervention; Usual Care

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,

You may not qualify if:

• none

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Eye Institute (NEI): collaborator

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location

Related Publications (1)

• 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.

  PMID: 28662043 DERIVED

MeSH Terms

Conditions

Trachoma

Interventions

Therapeutics; Azithromycin

Condition Hierarchy (Ancestors)

Conjunctivitis, Bacterial; Eye Infections, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Chlamydia Infections; Chlamydiaceae Infections; Gram-Negative Bacterial Infections; Eye Infections; Conjunctivitis; Conjunctival Diseases; Eye Diseases; Corneal Diseases

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals

Results Point of Contact

• Title: Sheila K West
• Organization: Johns Hopkins University

shwest@jhmi.edu

410 955 2606

Study Officials

• Sheila K West, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2013
• First Posted: January 14, 2013
• Study Start: January 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: February 1, 2016
• Last Updated: October 9, 2017
• Results First Posted: October 9, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will share

Locations

US (1)