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A recently published article in the journal “Med” describes the use of phage therapy (PASA16 phage), successfully treating several patients with refractory Pseudomonas aeruginosa infections. [Link]
This work is very important because infections with P. aeruginosa can be life-threatening, especially in people who are debilitated or immunocompromised. The publication is also important because it reminds us that often researchers can share their promising investigational treatments with patients who are not otherwise eligible to receive them (that is, not eligible to enroll in the clinical trial), thanks to the “compassionate use” pathway.
The work was carried out by a large multi-national team headed by Professors Ran Nir-Paz, Ronen Hazan and Hadil Onallah of Hadassah Medical Center-Hebrew University in Jerusalem, Israel.
Phage therapy is a type of treatment that uses viruses (“bacteriaohage”) that parasitize very specific bacteria. When the bacteria are completely eradicated, leaving no more hosts for the phage, they die off, too.
In clinical research, investigators can often petition for a “compassionate use” pathway, by which they can offer investigational treatments to patients who do not qualify to participate in the clinical study and therefore would not otherwise be able to take advantage of the risky but potentially life-saving treatment. Compassionate use is not an automatic part of all research studies. It must be requested by the investigators, approved by the regulators, paid for by the sponsors . . . it takes a lot of time and effort to add this option to a clinical study, and the “payoff” for the study team is often low, because none of these patients can be included in the data analysis for the study.
In this case, the payoff was wonderful for the patients who benefited from the treatment, and for the researchers who gained experience and some preliminary data upon which to support future research. PASA16 phage was administered to 16 patients, 15 of whom were available for follow-up. To date, 13 of the 15 patients completely recovered or dramatically improved from their potentially fatal infections (in 6 patients, all subsequent cultures were negative; for 7 patients, repeat cultures could not be obtained). Only 2 patients failed to improve clinically, one of whom continued to harbor P. aerugenosa on repeat cultures.
You can read the full study here.
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