Effect of Mass Distribution of Azithromycin for Trachoma Control on Overall Mortality in Ethiopian Children: A Randomized Trial

18 Sep 2009

Paul Chinnock

Source: Journal of the American Medical Association (see original article or PDF)

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Citation: Travis C. Porco, Teshome Gebre, Berhan Ayele, Jenafir House, Jeremy Keenan, Zhaoxia Zhou, Kevin Cyrus Hong, Nicole Stoller, Kathryn J. Ray, Paul Emerson, Bruce D. Gaynor, and Thomas M. Lietman (2009). Effect of Mass Distribution of Azithromycin for Trachoma Control on Overall Mortality in Ethiopian Children: A Randomized Trial. JAMA; 302(9):962-968.

An Ethiopian girl receives azithromycin treatment. Carter Center

Trachoma is the world’s biggest cause of preventable blindness. Prevention efforts involve the implementation of the WHO-recommended SAFE strategy: surgery for trichiasis (inturned eyelashes), antibiotics, facial cleanliness and environmental improvement. The antibiotic used as part of SAFE is azithromycin, which is known to be active also against several other infectious diseases.

Could it be therefore that mass azithromycin distribution programmes in trachoma-endemic areas also help protect against other infections? A trial conducted by Ethiopian and US researchers strongly suggests that this is the case.

The study compared the mortality rates of Ethiopian children aged 1-9 years in communities receiving azithromycin with those in control communities where the introduction of treatment was delayed by one year. Forty-eight communities were randomized into one of three 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 the control group (18,498 participants).

Child mortality rates in treated communities were found to be around half the figure in the control communities.

Among about 13,000 children in the treated villages, there were 45 deaths, whereas among the 5,100 children in the control villages, there were 37 deaths. This is equivalent to mortality in the 1-9 age group of 4.1 per 1000 person-years in treated communities and 8.3 per 1000 person-years in untreated communities. Surprisingly the number of times that children were treated per year seemed to have no significant effect on mortality rates.

The researchers speculate that the reduction in deaths was due to the protection given by azithromycin against pneumonia, diarrhoea and malaria, which are the biggest killers of Ethiopian children.

No data is available on mortality rates before the one-year study began. Information on the causes of death is incomplete; that which is available is based on verbal autopsy. And the trial data casts no light on the longer-term impact of the intervention.

Nevertheless, despite these limitations, the trial provides support for the expansion of mass azithromycin administration programmes.

The US Carter Center, founded by former President Jimmy Carter provided support for the research. In a press release the former president commented, “This study shows trachoma control goes far beyond blindness prevention – it also saves lives”.

Note: The publishers of this trial have not made it available with free or open access. To see the full article, therefore, a subscription to the Journal of the American Medical Association is required. In some developing countries readers based within institutions may be able to access the article through the HINARI programme.

2009 American Medical Association.

Source

Title:
Effect of mass distribution of azithromycin for trachoma control on overall mortality in Ethiopian children: a randomized trial.

Authors:
Porco TC, Gebre T, Ayele B, House J, Keenan J, Zhou Z, Hong KC, Stoller N, Ray KJ, Emerson P, Gaynor BD, Lietman TM

References:
JAMA 2 Sep 2009: Vol. 302 no. 9, pp. 962-8

Abstract:
CONTEXT: 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. DESIGN, SETTING, AND PARTICIPANTS: 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. INTERVENTIONS: 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. MAIN OUTCOME MEASURE: 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. CONCLUSION: In a trachoma-endemic area, mass distribution of oral azithromycin was associated with reduced mortality in children. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00322972.

PMID: 19724043
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