Trachoma Clinical Trial
Official title:
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.
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.
n/a
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