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Refractory Pseudomonas aeruginosa infections treated with phage PASA16: A compassionate use case series
Hadil Onallah1, Ronen Hazan2, Ran Nir-Paz3
1Faculty of Medicine, Hebrew University of Jerusalem, Jerusalem 9112102, Israel; The Israeli Phage Therapy Center (IPTC) of Hadassah Medical Center and the Hebrew University, Jerusalem 9112102, Israel.
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.
Insights
Phage therapy using PASA16 demonstrated significant success in treating difficult Pseudomonas aeruginosa infections. This compassionate use case series offers valuable insights for future clinical trials in phage therapy.
Area of Science:
- Microbiology
- Infectious Diseases
- Biotechnology
Background:
- Phage therapy is gaining traction for compassionate use cases, yet clinical trial evidence remains limited.
- There is a notable gap in understanding phage efficacy for refractory infections.
- This study presents the largest compassionate-use case series of a single phage (PASA16) for non-resolving Pseudomonas aeruginosa infections.
Purpose of the Study:
- To evaluate the safety and efficacy of PASA16 phage therapy in patients with refractory Pseudomonas aeruginosa infections.
- To summarize clinical data, administration protocols, and outcomes of compassionate-use PASA16 phage therapy.
- To provide insights for designing future clinical trials in phage therapy.
Main Methods:
- A case series of 16 patients with non-resolving Pseudomonas aeruginosa infections treated with PASA16 phage.
- Data collected included phage microbiology susceptibility, administration routes (intravenous, local, topical), and clinical outcomes.
- PASA16 phage was manufactured by Adaptive Phage Therapeutics.
Main Results:
- 13 out of 15 evaluable patients (86.6%) achieved a good clinical outcome.
- Minor side effects included transient elevated liver enzymes and reduced white blood cell count.
- Two cases reported clinical failure.
Conclusions:
- PASA16 phage, in combination with antibiotics, showed considerable success in patients with previously untreatable infections.
- This pre-phase-1 cohort study can inform clinical protocols and guide the design of future randomized controlled trials.
- Phage therapy represents a promising avenue for managing refractory Pseudomonas aeruginosa infections.
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