Sourcing phages for compassionate use
Jessica C Sacher A , Jan Zheng A and Shawna McCallin B C
+ Author Affiliations
- Author Affiliations
A Phage Directory, 151 Ted Turner Drive NW, Atlanta, GA 30303, USA
B Unit of Regenerative Medicine, Department of Musculoskeletal Medicine, Service of Plastic, Reconstructive, and Hand Surgery, University Hospital of Lausanne (CHUV), Switzerland
C Tel: +417 9791 9543, Email: shawna.mccallin@gmail.com
Microbiology Australia 40(1) 24-27 https://doi.org/10.1071/MA19012
Published: 22 February 2019
Abstract
Antibiotic resistance is a phenomenon that knows no geographical borders, so addressing this crisis is a worldwide public health priority. While total global resistance rates are difficult to estimate and vary between countries, an international report asserts that the development of new antibacterials is essential to ensuring the future ability to treat bacterial infections1. Bacteriophage (phage) therapy is a likely contributor to resolving potentially devastating effects of antibiotic resistance, yet no phage product currently holds a marketing authorisation that would permit their free use in clinical medicine outside of former countries of the Soviet Union, where phage therapy is a long-standing practice2,3. In the interim, the compassionate use of phage therapy (cPT) remains a possible treatment avenue for cases of antibiotic failure, and several competency centres, physicians, and researchers have achieved therapeutic benefits with this option. As antibiotic resistance continues to rise, there is much to be done in order to streamline cPT efforts, particularly in terms of phage sourcing, in order to reach more patients in an efficient, effective, and safe manner. This article highlights how cPT can be coordinated, and describes the experience of cPT in Australia.
References
[1] O’Neill J. (2016) Tackling drug-resistant infections globally: final report and recommendations. Review on antimicrobial resistance. London, UK.[2] Kutateladze, M. (2015) Experience of the Eliava Institute in bacteriophage therapy. Virol. Sin. 30, 80–81.
| Experience of the Eliava Institute in bacteriophage therapy.Crossref | GoogleScholarGoogle Scholar | 25662889PubMed |
[3] Sulakvelidze, A. et al. (2001) Bacteriophage therapy. Antimicrob. Agents Chemother. 45, 649–659.
| Bacteriophage therapy.Crossref | GoogleScholarGoogle Scholar | 11181338PubMed |
[4] World Medical Association (2013) World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA 310, 2191–2194.
| World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects.Crossref | GoogleScholarGoogle Scholar | 24141714PubMed |
[5] Balasubramanian, G. et al. (2016) An overview of compassionate use programs in the European Union member states. Intractable Rare Dis. Res. 5, 244–254.
| An overview of compassionate use programs in the European Union member states.Crossref | GoogleScholarGoogle Scholar | 27904819PubMed |
[6] Bunnik, E.M. et al. (2017) The changing landscape of expanded access to investigational drugs for patients with unmet medical needs: ethical implications. J. Pharm. Policy Pract. 10, 10.
| The changing landscape of expanded access to investigational drugs for patients with unmet medical needs: ethical implications.Crossref | GoogleScholarGoogle Scholar | 28239479PubMed |
[7] Jarow, J.P. et al. (2017) Overview of FDA’s expanded access program for investigational drugs. Ther. Innov. Regul. Sci. 51, 177–179.
| Overview of FDA’s expanded access program for investigational drugs.Crossref | GoogleScholarGoogle Scholar | 28553565PubMed |
[8] Donovan, P. (2017) Access to unregistered drugs in Australia. Aust. Prescr. 40, 194–196.
| Access to unregistered drugs in Australia.Crossref | GoogleScholarGoogle Scholar | 29109604PubMed |
[9] (ACSQHC) ACoSaQiHC (2017) Aura 2017: second Australian report on antimicrobial use and resistance in human health. Sydney: ACSQHC.
[10] Aslam, S. et al. (2018) Bacteriophage treatment in a lung transplant recipient. J. Heart Lung Transplant. 37, S155–S156.
| Bacteriophage treatment in a lung transplant recipient.Crossref | GoogleScholarGoogle Scholar |
[11] Sybesma, W. et al. (2018) Silk route to the acceptance and re-implementation of bacteriophage therapy–part II. Antibiotics 7, 35.
| Silk route to the acceptance and re-implementation of bacteriophage therapy–part II.Crossref | GoogleScholarGoogle Scholar |
[12] Ferry, T. et al. (2018) Innovations for the treatment of a complex bone and joint infection due to XDR Pseudomonas aeruginosa including local application of a selected cocktail of bacteriophages. J. Antimicrob. Chemother. 73, 2901–2903.
| Innovations for the treatment of a complex bone and joint infection due to XDR Pseudomonas aeruginosa including local application of a selected cocktail of bacteriophages.Crossref | GoogleScholarGoogle Scholar | 30060002PubMed |
[13] Ferry, T. et al. (2018) Salvage debridement, antibiotics and implant retention (‘DAIR’) with local injection of a selected cocktail of bacteriophages: is it an option for an elderly patient with relapsing Staphylococcus aureus prosthetic-joint infection? Open Forum Infect. Dis. 5, ofy269.
| 30474047PubMed |
[14] Fish, R. et al. (2018) Resolving digital staphylococcal osteomyelitis using bacteriophage–a case report. Antibiotics 7, 87.
| Resolving digital staphylococcal osteomyelitis using bacteriophage–a case report.Crossref | GoogleScholarGoogle Scholar |
[15] Patey, O. et al. (2018) Clinical indications and compassionate use of phage therapy: personal experience and literature review with a focus on osteoarticular infections. Viruses 11, 18.
| Clinical indications and compassionate use of phage therapy: personal experience and literature review with a focus on osteoarticular infections.Crossref | GoogleScholarGoogle Scholar |
[16] Chan, B.K. et al. (2018) Phage treatment of an aortic graft infected with Pseudomonas aeruginosa. Evol. Med. Public Health 2018, 60–66.
| Phage treatment of an aortic graft infected with Pseudomonas aeruginosa.Crossref | GoogleScholarGoogle Scholar | 29588855PubMed |
[17] Fish, R. et al. (2016) Bacteriophage treatment of intransigent diabetic toe ulcers: a case series. J. Wound Care 25, S27–S33.
| Bacteriophage treatment of intransigent diabetic toe ulcers: a case series.Crossref | GoogleScholarGoogle Scholar |
[18] Schooley, R.T. et al. (2017) Development and use of personalized bacteriophage-based therapeutic cocktails to treat a patient with a disseminated resistant Acinetobacter baumannii infection. Antimicrob. Agents Chemother. 61, e00954-17.
| Development and use of personalized bacteriophage-based therapeutic cocktails to treat a patient with a disseminated resistant Acinetobacter baumannii infection.Crossref | GoogleScholarGoogle Scholar | 28807909PubMed |
[19] Letkiewicz, S. et al. (2009) Eradication of Enterococcus faecalis by phage therapy in chronic bacterial prostatitis — case report. Folia Microbiol. (Praha) 54, 457–461.
| Eradication of Enterococcus faecalis by phage therapy in chronic bacterial prostatitis — case report.Crossref | GoogleScholarGoogle Scholar | 19937220PubMed |
[20] Ujmajuridze, A. et al. (2018) Adapted bacteriophages for treating urinary tract infections. Front. Microbiol. 9, 1832.
| Adapted bacteriophages for treating urinary tract infections.Crossref | GoogleScholarGoogle Scholar | 30131795PubMed |
[21] Khawaldeh, A. et al. (2011) Bacteriophage therapy for refractory Pseudomonas aeruginosa urinary tract infection. J. Med. Microbiol. 60, 1697–1700.
| Bacteriophage therapy for refractory Pseudomonas aeruginosa urinary tract infection.Crossref | GoogleScholarGoogle Scholar | 21737541PubMed |
[22] Abedon, S.T. (2017) Information phage therapy research should report. Pharmaceuticals (Basel) 10, 43.
| Information phage therapy research should report.Crossref | GoogleScholarGoogle Scholar |
[23] Phage Directory Atlanta Georgia 2017 https://phage.directory
[24] AmpliPhi Biosciences Corporation (2017) AmpliPhi Biosciences announces first intravenous treatment of a patient with AB-SA01 targeting Staphylococcus aureus [press release]. San Diego, CA, 11 September 2017.
[25] (2018) AmpliPhi to collaborate with Western Sydney Local Health District and Westmead Institute for Medical Research on expanded access for investigational bacteriophage therapeutics AB-SA01 and AB-PA01 [press release]. San Diego, CA, 19 March 2018.
[26] (2018) AmpliPhi Biosciences Announces presentation of positive clinical data from its expanded access program for serious S. aureus infections at IDWeek 2018 conference [press release]. San Diego, CA, 8 October 2018.
[27] Weber-Dąbrowska, B. et al. (2016) Bacteriophage procurement for therapeutic purposes. Front. Microbiol. 7, 1177.
| 27570518PubMed |
[28] Weber-Dabrowska, B. et al. (2000) Bacteriophage therapy of bacterial infections: an update of our institute’s experience. Arch. Immunol. Ther. Exp. (Warsz.) 48, 547–551.
| 11197610PubMed |
[29] Weber-Dabrowska, B. et al. (2001) Bacteriophage therapy for infections in cancer patients. Clin. Appl. Immunol. Rev. 1, 131–134.
| Bacteriophage therapy for infections in cancer patients.Crossref | GoogleScholarGoogle Scholar |
[30] Weber-Dabrowska, B. et al. (2003) Bacteriophages as an efficient therapy for antibiotic-resistant septicemia in man. Transplant. Proc. 35, 1385–1386.
| Bacteriophages as an efficient therapy for antibiotic-resistant septicemia in man.Crossref | GoogleScholarGoogle Scholar | 12826166PubMed |
[31] LaVergne, S. et al. (2018) Phage therapy for a multidrug-resistant Acinetobacter baumannii craniectomy site infection. Open Forum Infect. Dis. 5, ofy064.
| Phage therapy for a multidrug-resistant Acinetobacter baumannii craniectomy site infection.Crossref | GoogleScholarGoogle Scholar | 29687015PubMed |
[32] Pirnay, J.P. et al. (2018) The magistral phage. Viruses 10, 64.
| The magistral phage.Crossref | GoogleScholarGoogle Scholar |
