Am I eligible for phage therapy?
Phage therapy is not currently a licensed treatment in the United States. However, patients with serious multi-drug resistant or device-related bacterial infections that are not responding to antibiotics may be eligible for phage therapy through a special request from the Food and Drug Administration’s EIND procedure. If you meet specific criteria and are being treated at UC San Diego Health, our medical team can make this request to the FDA. If you are receiving care elsewhere, we can provide your doctor with advice about how to make this request.
What kinds of infections does IPATH treat?
Currently, IPATH is prioritizing serious multi-drug resistant bacterial infections that are associated with the following conditions: cystic fibrosis, complicated urinary tract infections, organ transplantation and implantable hardware, such as cardiac devices or joint replacements. Currently, phage therapy to treat Borrelia infections and/or Lyme disease, is not ready to admnister to humans.
I don't live in San Diego but I think I am eligible for phage therapy. What should I do?
Have your physician
contact IPATH. We will request your physician to share details of your case with us so that we can advise them if phage therapy is a viable option. You'll need to provide your physician or referring facility with authorization to share this information with us. If our medical team confirms that you are eligible for phage therapy, we will ask that your physician complete the following steps:
1. If upon review of your medical history you become a candidate under IPATH, your physician will need to send your bacterial culture to a laboratory where our collaborators will determine if they have bacteriophage(s) in their phage library active against the bacterium or bacteria causing your illness. This step might take 1-3 weeks once the bacterial isolates have been shipped. There is a possibility that matching phages will not be identified.
2. If our collaborators can confirm that we have phages active against your organism, IPATH or your physician will submit an
Emergency Investigational New Drug Application (EIND) to U.S. Food and Drug Administration (FDA). If you are not being treated at UC San Diego, your physician would need to subsequently notify a local investigational review board (usually at the hospital) about the use of phage therapy according to the procedures outlined by the FDA’s EIND process. We will be able to provide your physician with advice on how this is accomplished.
3. The propagation and purification of a particular phage cocktail for clinical use could take up to 4 weeks. We will make sure your physician acquires the phage(s) as soon as possible for your treatment.
I don’t live in San Diego and need to find a doctor in my city who would agree to providing me with phage therapy with help from IPATH. What should I do?
It is best if your primary care provider refers you to an infectious disease specialist in your area. If needed, your primary care provider can reach out to IPATH for specialist recommendations. IPATH will then be able to discuss with your infectious disease specialist, if phage therapy is an appropriate option for you.
What experience has IPATH had in treating patients with phage therapy?
Since 2016, we have treated 7 patients at UC San Diego with multi-drug resistant or device-related bacterial infections, including multi-drug resistant
Pseudomonas aeruginosa pneumonia, multi-drug resistant
Acinetobacter baumannii abdominal and cranial infections, and left ventricular assist device infections. We have also consulted on many more phage therapy cases across the United States and globally. Read more about these cases in the
scientific literature and
the press.
Does IPATH do consultations for physicians who want to learn more about offering phage therapy to their patients?
Yes, we provide consultations in the United States and internationally.
Contact IPATH for more details.
Can I get phage therapy in another hospital outside of UC San Diego?
Any licensed physician in the U.S. can request an Emergency New Drug Application (EIND) from the Food and Drug Administration to administer bacteriophages and other products that have not completed the approval process. IPATH can provide your doctor with advice about how to request and complete an EIND if needed.
Does my health insurance cover phage therapy?
There are no charges for the therapy itself. Your insurance company would be responsible for other aspects of your medical care.
