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Comparison of Annual and Biannual Mass Antibiotic Administration for Elimination of Infectious Trachoma

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Comparison of Annual and Biannual Mass Antibiotic Administration for Elimination of Infectious Trachoma ORIGINAL CONTRIBUTION Comparison of Annual and Biannual Mass Antibiotic Administration for Elimination of Infectious Trachoma Muluken Melese, MD, MPH Context Treatment recommendations assume that repeated mass antibiotic distri- Wondu Alemayehu, MD, MPH butions can control, but not eradicate or even locally eliminate, the ocular strains of Takele Lakew, MD, MPH chlamydia that cause trachoma. Elimination may be an important end point because of concern that infection will return to communities that have lost immunity to chla- Elizabeth Yi, MPH mydia after antibiotics are discontinued. Jenafir House, MPH, MSW Objective To determine whether biannual treatment can eliminate ocular chla- Jaya D. Chidambaram, MBBS mydial infection from preschool children and to compare results with the World Health Organization–recommended annual treatment. Zhaoxia Zhou, BA Design, Setting, and Participants A cluster-randomized clinical trial of biannual Vicky Cevallos, MT vs annual mass azithromycin administrations to all residents of 16 rural villages in the Kathryn Ray, MA Gurage Zone, Ethiopia, from March 2003 to April 2005. Kevin Cyrus Hong, BA Interventions At scheduled treatments, all individuals aged 1 year or older were Travis C. Porco, PhD, MPH offered a single dose of oral azithromycin either annually or biannually. Isabella Phan, MD Main Outcome Measure Village prevalence of ocular chlamydial infection and pres- ence of elimination at 24 months in preschool children determined by polymerase chain Ali Zaidi, MD reaction, correcting for baseline prevalence. Antibiotic treatments were performed af- Bruce D. Gaynor, MD ter sample collections. John P. Whitcher, MD, MPH Results Overall, 14 897 of 16 403 eligible individuals (90.8%) received their sched- uled treatment. In the villages in which residents were treated annually, the prevalence Thomas M. Lietman, MD of infection in preschool children was reduced from a mean of 42.6% (range, 14.7%- RACHOMA IS THE LEADING 56.4%) to 6.8% (range, 0.0%-22.0%) at 24 months. In the villages in which residents infectious cause of blindness were treated biannually, infection was reduced from 31.6% pretreatment (range, 6.1%- 1 48.6%) to 0.9% (range, 0.0%-4.8%) at 24 months. Biannual treatment was associated worldwide. Although it has with a lower prevalence at 24 months (P=.03, adjusting for baseline prevalence). At 24 been eliminated from Western months, no infection could be identified in 6 of 8 of those treated biannually and in 1 of TEurope and the United States, it is still 8 of those treated annually (P=.049, adjusting for baseline prevalence). endemic in poor, arid areas such as 2,3 Conclusion Local elimination of ocular chlamydial infection appears feasible even rural sub-Saharan Africa. The World in the most severely affected areas, although it may require biannual mass antibiotic Health Organization (WHO) has distributions at a high coverage level. launched a program to control tra- Trial Registration clinicaltrials.gov Identifier: NCT00221364 choma, relying in large part on annual JAMA. 2008;299(7):778-784 www.jama.com repeated mass azithromycin adminis- trations.2 Program administrators mydia may be obtainable.4-8 Elimina- Author Affiliations: Orbis International, Addis Ababa, anticipate that the treatments will tion has become a particularly Ethiopia (Drs Melese, Alemayehu, and Lakew) and FI reduce the prevalence of the ocular Proctor Foundation (Drs Lakew, Porco, Phan, Zaidi, important end point because of a Gaynor, Whitcher, and Lietman, Mss Yi, House, Chi- strains of chlamydia that cause tra- growing concern that infection may dambaram, Zhou, Cevallos, and Ray, and Mr Hong), choma to a level low enough that Departments of Ophthalmology (Drs Phan, Gaynor, return into communities that have lost resulting blindness will no longer be a Whitcher, and Lietman) and Epidemiology and Biosta- some of their immunity to chlamydia tistics (Drs Porco, Whitcher, and Lietman), and Insti- major public health concern. How- tute for Global Health (Drs Whitcher and Lietman), Uni- after antibiotics are discontinued.9,10 ever, local elimination of ocular chla- versity of California, San Francisco. Mathematical models suggest that Corresponding Author: Thomas M. Lietman, MD, 513 elimination is possible, but may Parnassus Ave, Room S309, FI Proctor Foundation, Uni- For editorial comment see p 819. versity of California, San Francisco, San Francisco, CA require relatively frequent treatments 94143-0944 ([email protected]). 778 JAMA, February 20, 2008—Vol 299, No. 7 (Reprinted) ©2008 American Medical Association. All rights reserved. Downloaded From: https://jamanetwork.com/ on 09/26/2021 MASS ANTIBIOTIC ADMINISTRATION FOR ELIMINATION OF INFECTIOUS TRACHOMA in hyperendemic regions where more Figure 1. Flow of Participants Through Each Stage of the Cluster-Randomized Trial than 30% of children have evidence of 11-14 infection. These models predict 16 Villages assessed for eligibility (mean that in a severely affected area of population aged >1 y per village [range], Ethiopia, biannual coverage of 80% of 338 [188-520]) the population may eliminate infec- tion while annual treatments may 16 Villages (5410 individuals) randomized not.12 In this study, we tested this hypothesis by comparing mass treat- 8 Villages (2645 individuals) randomized to 8 Villages (2765 individuals) randomized to ments given annually and biannually receive annual treatment receive biannual treatment in an area hyperendemic for trachoma. METHODS 8 Villages received intervention as assigned 8 Villages received intervention as assigned 2302 Individuals received treatment at 2488 Individuals received treatment at Sixteen adjacent villages from 3 baseline (mean, 378 per village baseline (mean, 346 per village [range, 200-514]) [range, 245-520]) Kebele (government units which, in 2522 Individuals received treatment at 2470 Individuals received treatment at this area, typically contain 5 to 6 vil- 12 mo (mean, 351 per village 6 mo (mean, 333 per village lages) in the Goro district of the [range, 188-472]) [range, 245-413]) 2577 Individuals received treatment at Gurage Zone of southern Ethiopia 12 mo (mean, 336 per village were censused in February 2003. [range, 241-413]) Eight villages were randomly assigned 2538 Individuals received treatment at 18 mo (mean, 355 per village to receive annual treatments and 8 to [range, 245-413]) receive biannual treatments (genera- tion by the RAND command in Excel 8 Villages (402 children aged 1-5 y) 8 Villages (373 children aged 1-5 y) by T.M.L., implementation including included in analysis included in analysis enrollment and assignment of partici- 66 Children excludeda 81 Children excludeda pants by M.M., FIGURE 1). Censuses a The 3 most common reasons for exclusion were absence from village, moved to another village, and death. were performed by individuals masked to study group assignment and to infection prevalence. At were obtained immediately after the ini- Pretreatment samples were tested in- scheduled treatments, those aged 1 tial study swab: a duplicate control (2 dividually. Posttreatment samples from year and older were offered a single swabs of the same child) in 5 ran- the same village were randomized and dose of oral azithromycin (1g for domly selected children in each vil- pooled into groups of 5, with a pos- adults or 20 mg/kg for children). lage and a negative field control passed sible remainder pool of 1 to 4 samples. Consumption of doses was directly within an inch of, but not touching, the Each pool was then tested according to observed. Pregnant women and those conjunctiva of 5 different children who the Amplicor protocol. If two-thirds or allergic to macrolides were offered a were also randomly selected in each vil- more of the pools tested positive for chla- 6-week course of topical 1% tetracy- lage. Examiners then changed gloves mydia, the individual samples were re- cline ointment (applied twice daily to before obtaining swabs from the next pooled randomly into groups of 2 and both eyes and not directly observed). child. reprocessed to allow for a more accu- Those younger than 1 year were not In addition to the preschool sur- rate estimation.15 If PCR of any pool was treated because oral azithromycin vey, we used the census from each equivocal, then all samples from the pool had not yet been approved for use in village to select a simple random were individually retested. The preva- this age group. Antibiotics were dis- sample of 25 individuals older than 5 lence of ocular chlamydial infection in tributed after swabbing was com- years to assess the prevalence of ocu- each village was obtained by maxi- pleted, within 2 weeks of the swab- lar chlamydial infection in the whole mum likelihood estimation.12 The num- bing. community at 18 and 24 months. All ber of positive individual samples most Children aged 1 to 5 years in treated samples were kept at 4°C in the field likely to have resulted in the observed villages were assessed for the presence and frozen at −20°C within 6 hours. pooled PCR results was chosen as the of ocular chlamydial infection, at base- The swabs were shipped at 4°C to estimate for that village (Mathematica line (pretreatment) and at 2, 6, 12, 18, San Francisco, California, where they 5.0, Wolfram Research Inc, Cham- and 24 months after treatment. A Da- were stored at −70°C until processed. paign, Illinois). This procedure can ac- cron swab was passed firmly across the The Amplicor polymerase chain reac- curately estimate the prevalence in the right upper tarsal conjunctiva 3 times, tion (PCR) test (Roche Diagnostics, village as long as it is relatively low (ie, rotating approximately 120° between Branchburg, New Jersey) was used to Ͻ 10%), as is typically found after treat- each pass. Two types of field controls detect chlamydial DNA. ment.15 However, it does not identify in- ©2008 American Medical Association. All rights reserved. (Reprinted) JAMA, February 20, 2008—Vol 299, No.
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