Effect of mass distribution of azithromycin for trachoma control on overall mortality in Ethiopian children: a randomized trial.
BACKGROUND
Mass oral azithromycin distribution to affected communities is a cornerstone of the World Health Organization's trachoma elimination program. Antibiotics are provided to target the ocular strains of chlamydia that cause trachoma, but may also be efficacious against respiratory disease, diarrhea, and malaria--frequent causes of childhood mortality in trachoma-endemic areas.


OBJECTIVE
To compare mortality rates of participants aged 1 to 9 years in treated communities with those in untreated communities.


METHODS
We conducted a cluster-randomized clinical trial of mass azithromycin administration for trachoma control. Forty-eight communities (known as subkebeles) were randomized into 1 of 3 treatment schedules (annual treatment of all residents [15,902 participants], biannual treatment of all residents [17,288 participants], or quarterly treatment of children only [14,716 participants]) or into 1 group for which treatment was delayed by 1 year (control, 18,498 participants). Twelve subkebeles were randomized to each of the 4 schedules with all children in each of the 3 communities being eligible for treatment. The trial was conducted in a field setting in rural Ethiopia, May 2006 to May 2007.


METHODS
A single dose of oral azithromycin (adults, 1 g; children, 20 mg/kg) was administered for treatment of ocular Chlamydia trachomatis infection. Antibiotic coverage levels for children aged 1 to 9 years exceeded 80% at all visits.


METHODS
The main outcome measure was the community-specific mortality risk for children aged 1 to 9 years over the course of 1 year. Mortality was measured by enumerative census at baseline and again after 1 year. Comparison of the risk of mortality was a prespecified outcome for the clinical trial.


RESULTS
The odds ratio for childhood mortality in the intervention communities was 0.51 (95% confidence interval, 0.29-0.90; P = .02; clustered logistic regression) compared with the control group. In the treated communities, the estimated overall mortality rate during this period for children aged 1 to 9 years in the untreated group was 8.3 per 1000 person-years (95% confidence interval, 5.3-13.1), while among the treated communities, the estimated overall mortality rate was 4.1 per 1000 person-years (95% confidence interval, 3.0-5.7) for children aged 1 to 9 years.


CONCLUSIONS
In a trachoma-endemic area, mass distribution of oral azithromycin was associated with reduced mortality in children.


BACKGROUND
clinicaltrials.gov Identifier: NCT00322972.
Porco
Travis C
TC
F.I. Proctor Foundation, and Department of Ophthalmology, University of California San Francisco, San Francisco, CA 94143, USA.
Gebre
Teshome
T
Ayele
Berhan
B
House
Jenafir
J
Keenan
Jeremy
J
Zhou
Zhaoxia
Z
Hong
Kevin Cyrus
KC
Stoller
Nicole
N
Ray
Kathryn J
KJ
Emerson
Paul
P
Gaynor
Bruce D
BD
Lietman
Thomas M
TM
D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D019072:Antibiotic Prophylaxis; D017963:Azithromycin / Q000008:administration & dosage / Q000627:therapeutic use*; D002648:Child; D046688:Child Mortality; D002675:Child, Preschool; D005002:Ethiopia / Q000453:epidemiology; D006801:Humans; D007223:Infant; D007226:Infant Mortality; D012424:Rural Population; D014141:Trachoma / Q000188:drug therapy / Q000401:mortality / Q000517:prevention & control*; D016896:Treatment Outcome
D000900:Anti-Bacterial Agents; D017963:Azithromycin