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Global Shortage of Neonatal and Paediatric Antibiotic Trials: Rapid Review

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Global Shortage of Neonatal and Paediatric Antibiotic Trials: Rapid Review Open Access Research BMJ Open: first published as 10.1136/bmjopen-2017-016293 on 13 October 2017. Downloaded from Global shortage of neonatal and paediatric antibiotic trials: rapid review Georgina Thompson,1,2 Charlotte I Barker,1,3,4 Laura Folgori,1 Julia A Bielicki,1,5 John S Bradley,6,7 Irja Lutsar,8 Mike Sharland1,4 To cite: Thompson G, ABSTRACT Strengths and limitations of this study Barker CI, Folgori L, et al. Objectives There have been few clinical trials (CTs) Global shortage of neonatal on antibiotics that inform neonatal and paediatric drug ► A narrative literature review of registered clinical and paediatric antibiotic labelling. The rate of unlicensed and off-label prescribing trials: rapid review. BMJ Open trials in children. in paediatrics remains high. It is unclear whether the 2017;7:e016293. doi:10.1136/ ► Explicit reproducible methodology. current neonatal and paediatric antibiotic research pipeline bmjopen-2017-016293 ► Search strategy limited to ClinicalTrials.gov and is adequate to inform optimal drug dosing. Using the EudraCT. Entirety of clinical research in this field ► Prepublication history and ClinicalTrials. gov registry, this review aims to establish the might not have been captured. additional material for this paper current global status of antibiotic CTs in children up to 18 ► Search strategy was limited to open clinical trials. are available online. To view years of age. please visit the journal (http:// Active but not yet recruiting trials were not captured. Methods Studies were identified using key word searches dx. doi. org/ 10. 1136/ bmjopen- 2017- 016293). of the ClinicalTrials. gov registry and were manually filtered using prespecified inclusion/exclusion criteria. Received 7 February 2017 Results 76 registered open CTs of antibiotics in children in drug pharmacokinetics (PK) in neonates Accepted 17 August 2017 were identified globally; 23 (30%) were recruiting and children can lead to adverse reactions newborns (only 8 (11%) included preterm neonates), that are not seen in adult populations, these 52 (68%) infants and toddlers, 58 (76%) children and 4 54 (71%) adolescents. The majority of registered trials are very rare. Suboptimal antibiotic dosing, were late phase (10 (15%) phase 3 and 23 (35%) phase including underdosing and overdosing, can 4/pharmacovigilance). Two-thirds were sponsored by lead to toxicity and treatment failure and may non-profit organisations, compared with pharmaceutical drive antimicrobial resistance by encouraging companies (50 (66%) vs 26 (34%), respectively). A greater selection pressures on drug-resistant strains proportion of non-profit funded trials were efficacy-based of bacteria.5 http://bmjopen.bmj.com/ strategic trials (n=34, 68%), in comparison with industry- Since antibiotics are the most commonly led trials, which were most often focused on safety or prescribed medicines in children, it is pharmacokinetic data (n=17, 65%). Only 2 of the 37 antibiotics listed on the May 2016 Pew Charitable Trusts important to maximise our understanding of antibiotic development pipeline, currently being studied in their PK profiles to help determine optimal adults, appear to be currently recruiting in open paediatric drug dosing and ultimately to improve 6 CTs. outcomes. In the last decade, several initia- Conclusions This review highlights that very few tives have been established to encourage paediatric antibiotic CTs are being conducted globally, paediatric medicines research, bridging on September 28, 2021 by guest. Protected copyright. especially in neonates. There is a striking disparity noted the gap between adult and paediatric drug between antibiotic drug development programmes in development plans. Such initiatives include adults and children. the Paediatric Regulation (Paediatric Inves- tigation Plans (PIPs), introduced by the European Medicines Agency (EMA),7 and INTRODUCTION Pediatric Study Plans, by the US Food and 8 Widespread unlicensed and off-label Drug Administration (FDA)). Despite this, prescribing in paediatrics persists—as high there have been few advances in antibiotic 9 as 11.4% and 46.5%, respectively—yet the development for this population. paucity of clinical research involving chil- The global status of clinical research on dren that is conducted to inform optimal antibiotics in paediatrics is unknown. Using drug dosing, licensing and labelling remains registered records of clinical trials (CTs) For numbered affiliations see a problem.1 For certain medicines, drug effi- on ClinicalT rials. gov, this review aims (1) end of article. cacy can be extrapolated from adult data to summarise the current global status of Correspondence to provided that the pathology and drug expo- registered antibiotic research in children Georgina Thompson; sure are the same or sufficiently similar in and neonates and (2) to stimulate discus- gethomps@ sgul. ac. uk children as in adults.2 3 Although differences sion and collaboration among the relevant Thompson G, et al. BMJ Open 2017;7:e016293. doi:10.1136/bmjopen-2017-016293 1 Open Access BMJ Open: first published as 10.1136/bmjopen-2017-016293 on 13 October 2017. Downloaded from Figure 1 Flow chart. Clinical trial selection process. stakeholders on the neglect of antibiotic research in antifungals, antiprotozoals, antivirals and probiotics or children. prebiotics. The following records, which were investi- gating an antibiotic, were excluded: trials involving tuber- http://bmjopen.bmj.com/ culosis, malaria, cystic fibrosis, HIV, febrile neutropenic METHODS patients, topical or inhalational treatments and prophy- Data sources lactic antibiotics or records investigating alternative use The ClinicalT rials. gov registry (last accessed 8 November for antibiotics (eg, as an anti-inflammatory agent). 2016) is an international platform for the registration of The searches were conducted by GT. All eligible records CTs. It is a web-based registry, developed in 2000 by the were identified via manual filtering by GT, CIB, LF and National Institutes of Health and the FDA, to which trials MS, and any disagreements regarding inclusion and from 50 states and 163 countries around the world are exclusion of records were resolved through discussion. on September 28, 2021 by guest. Protected copyright. registered. Information provided for each trial is updated periodically by the trial’s sponsoring organisation. The Data extraction database has a specific child filter, which uses a key word The following information was collected from the paradigm to select all registered trials recruiting patients/ included records: unique ClinicalT rials.gov identifier participants up to 18 years of age. (NCT number), recruitment status, study design, trial Study selection phase, study sponsor, age group and sex eligibility, clinical Our records were identified using suitable key word indication, geographic region of recruitment, antibiotic searches, in which the final search terms were (antimicro- being investigated and endpoint classification. Outcomes bial* OR antibiotic* OR anti-infective agent*) AND Child were categorised as safety, efficacy or PK. Economic setting AND Open Studies. All identified trials were filtered (based on geographic region of recruitment) was classi- manually using inclusion and exclusion criteria. Interven- fied using The World Bank classification to differentiate tional and observational trials on antimicrobials recruiting between low-income countries (LICs), lower income and children up to 18 years of age were considered eligible middle-income countries (LMICs), upper middle-income for inclusion. No specific temporal filter was applied Countries (UMICs) and high-income countries (HICs).10 since only open or ongoing clinical trials were of interest. The specific class of antibiotic studied in each trial was The following records, which were not investigating one identified and classified using the WHO Anatomical, or more antibiotics, were excluded: trials of antiseptics, Therapeutic, and Chemical classification and Defined 2 Thompson G, et al. BMJ Open 2017;7:e016293. doi:10.1136/bmjopen-2017-016293 Open Access BMJ Open: first published as 10.1136/bmjopen-2017-016293 on 13 October 2017. Downloaded from Table 1 Characteristics of clinical trials Table 2 Clinical trial endpoint classification of identified Number of clinical trials stratified by trial sponsor Characteristic Category studies, n (%) Endpoint Age group Preterm neonates 1 (1)* classification Industry Non-profit Total (%) Neonates (total) 23 (30) Efficacy 9 34 43 (57) Infants and toddlers 52 (68) Safety 10 2 12 (16) Children 58 (76) PK 7 14 21 (28) Adolescents 54 (71) Endpoint classification determined by planned primary outcomes. Recruitment status Recruiting 63 (83) PK, pharmacokinetics. Not yet recruiting 13 (17) Study design Interventional 66 (87) were compared with the Pew Charitable Trusts Antibiotics Observational 10 (13) Currently in Clinical Development pipeline, which identifies Trial phase† Phase 1 10 (15) novel antibiotics currently under development for the US market.12 Phases 1–2 1 (2) Phase 2 9 (14) Phases 2–3 3 (5) RESULTS Phase 3 10 (15) Our search identified 1056 records. Six hundred and Phase 4 23 (39) three records were excluded on title because they were studies not involving an antimicrobial. Four hundred and Not specified 10 (15) fifty-three records were investigating one or more anti- Sponsor Industry 26 (34) microbials and recruiting children below 18 years of age. Non-profit 50 (66) Among the 195 trials investigating
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