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Safety and Efficacy of Tigecycline to Treat Multidrug-resistant Infections in Pediatrics: An Evidence Synthesis.

Sharland, M; Rodvold, KA; Tucker, HR; Baillon-Plot, N; Tawadrous, M; Hickman, MA; Raber, S; Korth-Bradley, JM; Díaz-Ponce, H; Wible, M (2019) Safety and Efficacy of Tigecycline to Treat Multidrug-resistant Infections in Pediatrics: An Evidence Synthesis. Pediatr Infect Dis J, 38 (7). pp. 710-715. ISSN 1532-0987 https://doi.org/10.1097/INF.0000000000002339
SGUL Authors: Sharland, Michael Roy

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Abstract

BACKGROUND: The need for antimicrobial therapies effective against multidrug resistant organisms for children remains unmet. Tigecycline shows antibacterial activity across a broad spectrum of bacteria and is approved for treating complicated skin and skin-structure infections, complicated intra-abdominal infections and, in the United States, community-acquired bacterial pneumonia for adult patients. No blinded, randomized phase 3 tigecycline clinical trials on neonates or children have been completed or planned. This review aimed to provide a comprehensive synthesis of all the existing data sources, both on-label and off-label, for tigecycline use in children. METHODS: Data on tigecycline use in children were identified from published and unpublished sources including clinical trials, expanded access and compassionate use programs, databases of healthcare records and patient safety monitoring. RESULTS: Pharmacokinetic simulations predicted that tigecycline 1.2 mg/kg (maximum dose 50 mg) every 12 hours (q12h) in children 8-11 years and 50 mg q12h in children 12 to <18 years would achieve exposure similar to adults receiving 50 mg q12h. Available phase 2 pediatric clinical trial data and data from other sources demonstrated similar clinical efficacy between adult and pediatric patients treated with tigecycline. These data showed no new or unexpected safety concerns with tigecycline in children. CONCLUSIONS: Information presented here may help guide the appropriate use of tigecycline in children with multidrug resistant infections. Continued pharmacovigilance from real-world observational studies may also further refine appropriate use of tigecycline.

Item Type: Article
Additional Information: This is the accepted manuscript version made available undr the CC BY-NC licence https://creativecommons.org/licenses/by-nc/4.0/ The final publisher version is available at http://doi.org/10.1097/INF.0000000000002339
Keywords: 1114 Paediatrics And Reproductive Medicine, Pediatrics
SGUL Research Institute / Research Centre: Academic Structure > Infection and Immunity Research Institute (INII)
Journal or Publication Title: Pediatr Infect Dis J
ISSN: 1532-0987
Language: eng
Dates:
DateEvent
July 2019Published
16 February 2019Accepted
Publisher License: Creative Commons: Attribution-Noncommercial 4.0
PubMed ID: 31192975
Go to PubMed abstract
URI: https://openaccess.sgul.ac.uk/id/eprint/110981
Publisher's version: https://doi.org/10.1097/INF.0000000000002339

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