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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 Emergency Investigational New Drug (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.
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 administer to humans.
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 they have phages active against your organism, IPATH or your physician will submit an EIND application 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 4-12 weeks. We will make sure your physician acquires the phage(s) as soon as possible for your treatment.
Phage therapy is still a very new treatment in the United States, so there are only a limited number of physicians who have experience in using phage therapy. Therefore, it is best if your primary care provider refers you to a local infectious disease physician, since they are best equipped to manage complex bacterial infections, such as those that may be eligible for phage therapy.
IPATH physicians are experienced in using phage therapy and can assist your physician in applying to the FDA and creating a treatment protocol. If you would like your infectious disease physician to consult with IPATH, your physician will need you to complete an authorization form that gives them permission to discuss your health information when they contact IPATH. Your physician should email ipath@health.ucsd.edu to request a phage therapy consultation.
A multidrug-resistant bacterial culture is needed before phage therapy can be considered. A bacterial culture is used to find active phages against the bacteria, and therefore finding phage would not be possible without a sample of the patient’s bacteria. Genetic sequencing tests cannot be used to find active phages, and therefore cannot be a replacement for a bacterial culture.
Since 2016, we have treated 10 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
Yes, we provide consultations in the United States and internationally. Contact IPATH for more details.
Any licensed physician in the U.S. can request an emergency IND from the FDA 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 emergency IND if needed.
The phage therapy and the process to find/purify/analyze the phages are done free of cost by the phage supplier. Typically, office visits and general health labs are covered by medical insurance.
The out-of-pocket costs can vary from institution to institution.Typically patients can be charged: