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Dose and formulation of azithromycin in mass drug administration studies: a systematic review protocol
  1. Yan Yue1,2,
  2. Tao Xiong1,2,
  3. Linan Zeng2,3,
  4. Imti Choonara4,
  5. Shamim Qazi5,
  6. Hongju Chen1,2,
  7. Dezhi Mu1,2
  1. 1Department of Pediatrics, West China Second University Hospital, Sichuan University, Chengdu, China
  2. 2Key Laboratory of Obstetrics & Gynecologic and Pediatric Diseases and Birth Defects of the Ministry of Education, Sichuan University, Chengdu, China
  3. 3Department of Pharmacy, Evidence-Based Pharmacy Center, West China Second University Hospital, Sichuan University, Chengdu, China
  4. 4Academic Division of Child Health, University of Nottingham School of Medicine, Derby, UK
  5. 5Department of Maternal Newborn Child and Adolescent Health, World Health Organization, Geneva, Switzerland
  1. Correspondence to Dr Tao Xiong; tao_xiong{at}


Introduction Azithromycin has been given for tropical infectious diseases such as trachoma and yaws by mass drug administration (MDA). As well as controlling the infectious disease in question, MDA may have a beneficial effect in reducing mortality in young children. However, the dose, formulation, frequency and duration of azithromycin used in certain infectious diseases may vary in different studies, and these differences may have impacts on the effectiveness of azithromycin MDA. Furthermore, whether the dose, formulation, frequency and duration are associated with the effectiveness of azithromycin for reducing child mortality—if indeed this effect can be confirmed—remain unknown. In this study, we will investigate whether different strategies such as different dose, formulation, frequency and duration affect the effectiveness of azithromycin MDA on the prevalence of certain infectious diseases or child mortality.

Methods and analysis A narrative systematic review will be conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. PubMed, Embase, the Cochrane Central Register of Controlled Trials, Web of Science, and WHO International Clinical Trials Registry Platform will be searched. No language restrictions will be applied. All randomised/quasi-controlled trials, observational studies (cross-sectional studies, cohort studies and case–control studies), case series and registered protocols will be considered. Dose, duration, frequency, rounds and formulations of azithromycin used in MDA will be collected and reviewed. The outcomes will be disease prevalence/control in children and child mortality. Data from the individual studies will not be pooled.

Ethics and dissemination Formal ethical approval is not required since data will be collected from published studies. This systematic review will be published in a peer-reviewed journal and presented at conference meetings.

PROSPERO registration number CRD42018114902

  • evidence based medicine

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  • Contributors YY designed and prepared this protocol; TX is involved in all aspects of the study and will coordinate the review process; LZ contributed to the revision of the protocol and will contribute to data collection and analysis; IC and SQ contributed to the idea of the topic and revised the manuscript. HC and DM contributed to the design of the quality assessment and will contribute to data collection and analysis. All coauthors contributed to the preparation and approval of this manuscript.

  • Funding Grants from WHO (WHO Registration 2018/859223-0); funding from Deep Underground Space Medical Center (NO. DUGM201809) and the National Science Foundation of China (81300525, 81501304).

  • Competing interests IC is editor in chief of BMJ Paediatrics Open.

  • Patient and public involvement statement This protocol was designed without patients and or public involvement.

  • Patient consent for publication Not required.

  • Ethics approval Formal ethical approval is not required since data are collected from published studies. The study will hopefully establish whether dose, duration or formulation of azithromycin are important in relation to either control of the underlying infection being treated or overall child mortality. This systematic review will be published in a peer-reviewed journal and presented at conference meetings.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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