Mortality Reduction After Oral Azithromycin Contingency: Mortality Study

Pre-trial treatments: in the original MORDOR trial, communities were randomized to 4 rounds
of biannual mass distributions of either azithromycin or placebo (i.e, the first two years of
the trial). All communities were subsequently treated with 2 rounds of biannual mass
azithromycin (i.e., the fifth and sixth rounds, during the third year of the trial).

Present trial design: The present trial enrolls all communities previously enrolled in the
Niger site of MORDOR, and re-randomizes communities to biannual mass distributions of either
azithromycin or placebo (i.e., the seventh and eighth rounds of mass drug administration
since randomization for the original MORDOR trial, occurring in the fourth year since
randomization). This results in four patterns of community-based treatment: four years of
azithromycin (AAAA), three years of azithromycin followed by one year of placebo (AAAP), two
years of placebo followed by two years of azithromycin (PPAA), and two years of placebo
followed by one year of azithromycin and then one year of placebo (PPAP). The primary outcome
will be all-cause mortality in children aged 1-59 months, as determined by biannual census.
The mortality rate following re-randomization (i.e., the seventh and eighth rounds of mass
drug administration) will be compared between the two re-randomized groups.

Inclusion Criteria:

- Communities- All communities eligible for MORDOR (NCT02047981)

- Individuals-All children aged 1-60 months (up to but not including the 5th birthday),
as assessed via biannual census

Exclusion Criteria:

- Refusal of village chief (for village inclusion), or refusal of parent or guardian
(for individual inclusion)