Adverse Events after Mass Azithromycin Treatments for Trachoma in Ethiopia

Berhan Ayele The Carter Center, Addis Ababa, Ethiopia; F.I. Proctor Foundation, Department of Ophthalmology, and Department of Epidemiology and Biostatistics, University of California, San Francisco, California

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Teshome Gebre The Carter Center, Addis Ababa, Ethiopia; F.I. Proctor Foundation, Department of Ophthalmology, and Department of Epidemiology and Biostatistics, University of California, San Francisco, California

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Jenafir I. House The Carter Center, Addis Ababa, Ethiopia; F.I. Proctor Foundation, Department of Ophthalmology, and Department of Epidemiology and Biostatistics, University of California, San Francisco, California

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Zhaoxia Zhou The Carter Center, Addis Ababa, Ethiopia; F.I. Proctor Foundation, Department of Ophthalmology, and Department of Epidemiology and Biostatistics, University of California, San Francisco, California

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Charles E. McCulloch The Carter Center, Addis Ababa, Ethiopia; F.I. Proctor Foundation, Department of Ophthalmology, and Department of Epidemiology and Biostatistics, University of California, San Francisco, California

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Travis C. Porco The Carter Center, Addis Ababa, Ethiopia; F.I. Proctor Foundation, Department of Ophthalmology, and Department of Epidemiology and Biostatistics, University of California, San Francisco, California

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Bruce D. Gaynor The Carter Center, Addis Ababa, Ethiopia; F.I. Proctor Foundation, Department of Ophthalmology, and Department of Epidemiology and Biostatistics, University of California, San Francisco, California

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Paul M. Emerson The Carter Center, Addis Ababa, Ethiopia; F.I. Proctor Foundation, Department of Ophthalmology, and Department of Epidemiology and Biostatistics, University of California, San Francisco, California

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Thomas M. Lietman The Carter Center, Addis Ababa, Ethiopia; F.I. Proctor Foundation, Department of Ophthalmology, and Department of Epidemiology and Biostatistics, University of California, San Francisco, California

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Jeremy D. Keenan The Carter Center, Addis Ababa, Ethiopia; F.I. Proctor Foundation, Department of Ophthalmology, and Department of Epidemiology and Biostatistics, University of California, San Francisco, California

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During a cluster-randomized clinical trial for trachoma in Ethiopia, two rounds of adverse event surveillance were performed in a random sample of communities after community-wide mass azithromycin treatment. The prevalence of any reported adverse event ranged from 4.9% to 7.0% in children 1–9 years of age and from 17.0% to 18.7% in persons ≥ 10 years of age. Adverse events appeared to cluster by household and perhaps by village. Mass azithromycin distributions were well tolerated in this setting.

Author Notes

*Address correspondence to Jeremy D. Keenan, F.I. Proctor Foundation, 513 Parnassus Avenue, Med Sci S309, Box 0412, University of California, San Francisco, CA 94143-0412. E-mail: jeremy.keenan@ucsf.edu

Financial support: This study was supported by the National Institutes of Health (grants NEI U10 EY016214, NEI K23 EY019071 and NIH/NCRR/OD UCSF-CTSI KL2 RR024130). We also thank the International Trachoma Initiative for the generous donation of azithromycin, and the Bernard Osher Foundation, That Man May See, the Bodri Foundation, the Harper Inglis Trust, the South Asia Research Fund, and Research to Prevent Blindness for support.

Disclosure: None of the authors has any conflicts of interest.

Authors' addresses: Berhan Ayele and Teshome Gebre, The Carter Center-Ethiopia Bole K.K., Addis Ababa, Ethiopia, E-mails: berhanayele@yahoo.com and teshumanga2002@yahoo.com. Jenafir I. House, Zhaoxia Zhou, Travis C. Porco, Bruce D. Gaynor, Thomas M. Lietman, and Jeremy D. Keenan, F.I. Proctor Foundation, University of California, San Francisco, CA, E-mails jenafirh@yahoo.com, zhaoxia.zhou@ucsf.edu, travis.porco@ucsf.edu, bruce.gaynor@ucsf.edu, tom.lietman@ucsf.edu, and jeremy.keenan@ucsf.edu. Charles E. McCulloch, Department of Epidemiology and Biostatistics, University of California, San Francisco, CA, E-mail: chuck@biostat.ucsf.edu. Paul M. Emerson, The Carter Center, Atlanta, GA, E-mail: paul.emerson@emory.edu.

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