Refractory Pseudomonas aeruginosa infections treated with phage PASA16: A compassionate use case series
Department
Infectious Diseases
Document Type
Article
Publication Title
Med (New York, N.Y.)
Abstract
BACKGROUND: A growing number of compassionate phage therapy cases were reported in the last decade, with a limited number of clinical trials conducted and few unsuccessful clinical trials reported. There is only a little evidence on the role of phages in refractory infections. Our objective here was to present the largest compassionate-use single-organism/phage case series in 16 patients with non-resolving Pseudomonas aeruginosa infections.
METHODS: We summarized clinical phage microbiology susceptibility data, administration protocol, clinical data, and outcomes of all cases treated with PASA16 phage. In all intravenous phage administrations, PASA16 phage was manufactured and provided pro bono by Adaptive Phage Therapeutics. PASA16 was administered intravenously, locally to infection site, or by topical use to 16 patients, with data available for 15 patients, mainly with osteoarticular and foreign-device-associated infections.
FINDINGS: A few minor side effects were noted, including elevated liver function enzymes and a transient reduction in white blood cell count. Good clinical outcome was documented in 13 out of 15 patients (86.6%). Two clinical failures were reported. The minimum therapy duration was 8 days with a once- to twice-daily regimen.
CONCLUSIONS: PASA16 with antibiotics was found to be relatively successful in patients for whom traditional treatment approaches have failed previously. Such pre-phase-1 cohorts can outline potential clinical protocols and facilitate the design of future trials.
FUNDING: The study was funded in part by The Israeli Science Foundation IPMP (ISF_1349/20), Rosetrees Trust (A2232), United States-Israel Binational Science Foundation (2017123), and the Milgrom Family Support Program.
First Page
600
Last Page
611.e4
DOI
10.1016/j.medj.2023.07.002
Volume
4
Issue
9
Publication Date
9-8-2023
Medical Subject Headings
Humans; Bacteriophages; Pseudomonas Infections; Compassionate Use Trials; Pseudomonas Phages; Anti-Bacterial Agents
PubMed ID
37562400
Recommended Citation
Onallah, H., Hazan, R., Nir-Paz, R., PASA16 study group., Brownstein, M., Fackler, J., Horne, B., Hopkins, R., Basu, S., Yerushalmy, O., Alkalay-Oren, S., Braunstein, R., Rimon, A., Gelman, D., Khalifa, L., Adler, K., Abdalrhman, M., Gelman, S., Katvan, E., Coppenhagen-Glazer, S., Moses, A., Oster, Y., Dekel, M., Ben-Ami, R., Khoury, A., Kedar, D. J., Meijer, S. E., Ashkenazi, I., Bishouty, N., Yahav, D., Shostak, E., Livni, G., Paul, M., Gross, M., Ormianer, M., Aslam, S., Ritter, M., Urish, K., La Hoz, R., Khatami, A., Britton, P., Lin, R., Iredell, J., Petrovic-Fabijan, A., Lynch, S., Tamma, P., Yamshchikov, A., Lesho, E., Morales, M., Werzen, A., & Saharia, K. (2023). Refractory Pseudomonas aeruginosa infections treated with phage PASA16: A compassionate use case series. Med (New York, N.Y.), 4 (9), 600-611.e4. https://doi.org/10.1016/j.medj.2023.07.002