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Safety of azithromycin in paediatrics: a systematic review protocol
  1. Peipei Xu1,2,3,4,
  2. Linan Zeng1,2,4,
  3. Tao Xiong5,
  4. Imti Choonara6,
  5. Shamim Qazi7,
  6. Lingli Zhang1,2,4
  1. 1 Departmentof Pharmacy, West China Second University Hospital,Sichuan University, Chengdu, China
  2. 2 Evidence-BasedPharmacy Center, West China Second University Hospital, Sichuan University, Chengdu, China
  3. 3 West China School of Medicine, Sichuan University, Chengdu, China
  4. 4 Key Laboratory of Obstetrics & Gynecologic and Pediatric Diseases and Birth Defects of the Ministry of Education, Sichuan University, Chengdu, China
  5. 5 Neonataldepartment, West China Second University Hospital, Sichuan University, Chengdu, China
  6. 6 AcademicDivision of Child Health, University of Nottingham, Derbyshire Children’sHospital, Derby, UK
  7. 7 Department of Maternal Newborn Child and Adolescent Health, World Health Organization, Geneva, Swaziland
  1. Correspondence to Dr Lingli Zhang; zhanglingli{at}


Introduction Azithromycin is widely used in children not only in the treatment of individual children with infectious diseases, but also as mass drug administration (MDA) within a community to eradicate or control specific tropical diseases. MDA has also been reported to have a beneficial effect on child mortality and morbidity. However, concerns have been raised about the safety of azithromycin, especially in young children. The aim of this review is to systematically identify the safety of azithromycin in children of all ages.

Methods and analysis MEDLINE, PubMed, Cochrane Central Register of Controlled Trials, Embase, CINAHL, International Pharmaceutical Abstracts and adverse drug reaction (ADR) monitoring systems will be systematically searched for randomised controlled trials (RCTs), cohort studies, case–control studies, cross-sectional studies, case series and case reports evaluating the safety of azithromycin in children. The Cochrane risk of bias tool, Newcastle-Ottawa and quality assessment tools, and The Joanna Briggs Institute Critical Appraisal tools will be used for quality assessment. Meta-analyses will be conducted to the incidence of ADRs from RCTs if appropriate. Subgroup analyses will be performed in different age and azithromycin dosage groups.

Ethics and dissemination Formal ethical approval is not required as no primary data are collected. This systematic review will be disseminated through a peer-reviewed publication.

PROSPERO registration number CRD42018112629

  • general paediatrics
  • therapeutics

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See:

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  • Contributors PPX contributed to developing and drafted the protocol. LNZ contributed to developing the protocol. IC contributed to supervised the development of the protocol and revise the protocol. TX, SQ and LNZ contributed to revise the protocol. All the authors have approved the current protocol version.

  • Funding This study was funded by the WHO (2018/859223-0).

  • Competing interests None declared.

  • Patient consent for publication Not required.

  • Ethics approval There is no need for an ethical assessment because we only search and evaluate the existing literature.

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

  • Data availability statement All the data relevant to the study are included in the article or uploaded as supplementary information.

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