Journal article
Standardised treatment and monitoring protocol to assess safety and tolerability of bacteriophage therapy for adult and paediatric patients (STAMP study): protocol for an open-label, single-arm trial
A Khatami, DA Foley, MS Warner, EH Barnes, AY Peleg, J Li, S Stick, N Burke, RCY Lin, J Warning, TL Snelling, SYC Tong, J Iredell
BMJ Open | Published : 2022
Open access
Abstract
Introduction There has been renewed interest in the therapeutic use of bacteriophages (phages); however, standardised therapeutic protocols are lacking, and there is a paucity of rigorous clinical trial data assessing efficacy. Methods and analysis We propose an open-label, single-arm trial investigating a standardised treatment and monitoring protocol for phage therapy. Patients included will have exhausted other therapeutic options for control of their infection and phage therapy will be administered under Australia's Therapeutic Goods Administration Special Access Scheme. A phage product with high in vitro activity against the targeted pathogen(s) must be available in line with relevant r..
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Grants
Awarded by Wellcome Trust
Funding Acknowledgements
We thank all additional members of the Phage Australia Clinical Network which includes David L. Paterson (University of Queensland, Royal Brisbane and Women's Hospital), Adam Irwin (The University of Queensland; Queensland Children's Hospital), Christopher Heath (Departments of Microbiology [PathWest Laboratory Medicine] and Infectious Diseases, Fiona Stanley Hospital Network), Anthony Kicic (Telethon Kid's Institute; Curtin University), Kim Chan (University of Sydney), Bernard Hudson (Royal North Shore Hospital), Holly A. Sinclair (Royal Brisbane and Women's Hospital) and Susan Maddocks (Western Sydney Local Health District) who contributed to the set up of the trial. We also thank Lani Attwood (Kids Advanced Therapeutics Program, Sydney Children's Hospitals Network) for her assistance in developing participant information sheets and obtaining ethical approval for the trial; and Jan Zheng and Jessica Sacher (Phage Directory; Westmead Institute for Medical Research) for their work developing the REDCap database for this trial.