Table 2.
Estimated eligible population and study timeline by region in Stages I and II of the AVENIR trial
| Region | Estimated eligible under-5 populationc | Estimated eligible communitiesd | Stage Ia | Stage IIb | ||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Year 1 | Year 2 | Year 3 | Year 3 | Year 4 | ||||||
| Round 1 | Round 2 | Round 3e | Round 4 | Round 5 | Round 6 | Round 7 | Round 8 | |||
| Dosso | 271,273 | 1800 | X* | X | X | X | X* | X | X | X |
| Tahoua (1st half) | 245,944 | 1250 | X | X | X | X | X | X | ||
| Tahoua (2nd half) | 245,944 | 1250 | X | X | X | X | X | |||
| Maradi (1st half) | 342,889 | 1700 | X | X | X | X | ||||
| Maradi (2nd half) | 342,890 | 1700 | X | X | X | |||||
| Zinder | 452,241 | 3860 | X | X | ||||||
| Tillabéri | 440,791 | 3070 | X | |||||||
| Total | 2,341,972 | 14,630 | ||||||||
Round = one distribution of azithromycin and/or placebo; x = census and treatment; x* = census, resistance assessments, treatment
a Stage I includes enrollment through the primary outcome analysis at 2.5 years from the first region enrollment
b Stage II is dependent upon primary outcome results, available resources, and security restrictions
c As estimated from projections by the Institute for Health Metrics and Evaluation multiplied by fraction of eligible grappes in each region
d Communities with total populations between 250 and 2499 not designated as urban quartiers according to the 2012 Niger national census. Dosso region estimates further exclude communities known to be located within 5 km of district headquarters town
Distance-based exclusions pending for the other 4 regions.
e Interim analysis to be conducted at 18 months from the first enrollment