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Introduction
In low- and middle-income countries, nearly one third of children experience at
least one episode of Shigella-attributable diarrhea during their first 2 years of life.
In addition to it being a leading cause of diarrhea, this enteric bacterium is also
associated with linear growth faltering, a precursor to stunting. Stunting is a
marker of vulnerability to childhood infection, decreased vaccine efficacy and
lifelong morbidity. Currently, several promising Shigella vaccines are in
development. Eventual Phase 2b/3 Shigella vaccine trials will require a consortium
of potential vaccine trial sites in settings with a high incidence of Shigella-
attributed medically-attended diarrhea, high participant retention, and the
¿ confirmed 𝑆h𝑖𝑔𝑒𝑙𝑙𝑎 cases enrolled
laboratory capacity to confirm Shigella infection. 𝐂𝐫𝐮𝐝𝐞 𝐈𝐧𝐜𝐢𝐝𝐞𝐧𝐜𝐞 =
Defined population ¿ × Time
+
A1=Proportion who seek care at EFGH facility B1=Proportion enrolled (among those who sought care
(among those with watery diarrhea) at the EFGH facility with watery diarrhea)
A2=Proportion who seek care at EFGH facility B2=Proportion enrolled (among those who sought care
(among those with dysentery) at the EFGH facility with dysentery)
Time=Period of time recruiting takes place (i.e. Defined population size=Estimated # of children aged 6-
24 months) 35 months living in the pre-defined catchment area
Outcomes
Primary Aims
1. Determine the incidence of Shigella-attributed MAD in children 6 to 35 months of age in each of the EFGH country
Objectives sites.
Secondary Aims
2. Determine the incidence of Shigella MAD by serotype, severity definition, laboratory method (culture vs. qPCR), age,
• EFGH study aims to determine the incidence and consequences of medically and by season.
attended Shigella diarrhea within the country sites. 3. Describe the prevalence of resistance to commonly used antibiotics in Shigella isolates in each EFGH country site.
4. Determine the risk of death, hospitalization, persistent diarrhea, diarrhea recurrence, and linear growth faltering in the
• Determine the incidence of Shigella-attributed medically-attended diarrhea in 3 months following an episode of Shigella MAD.
children 6 to 35 months of age in each of the EFGH country sites. 5. Compare various severity definitions in their ability to distinguish Shigella from non-Shigella attributable diarrhea and
ability to predict risk of death or hospitalization in the subsequent 3 months.
6. Quantify the cost incurred by families and health care systems due to Shigella morbidity and mortality.