Phage Therapy FAQ

Phage therapy is not currently a licensed treatment in the United States. However, patients with serious multidrug-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 or Singe Patient Expanded Access Investigational New Drug (IND) 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 multidrug-resistant bacterial infections that are associated with the following conditions: life- or limb-threatening bacterial infections, complicated urinary tract infections, organ transplantation and implantable hardware, such as cardiac devices or joint replacements.

Phage therapy may not be an appropriate option if a patient has cultured multiple bacteria over time. If it is difficult for physicians to determine which bacteria is causing the disease or if multiple are in play, phage therapy is likely not an option. At present, it is not feasible to find and prepare phages for multiple bacteria that may or may not be causing disease, as a large amount of time and energy are needed to find and prepare each phage.

Currently, phage therapy to treat Borrelia infections and/or Lyme disease, is not ready to administer to humans.

Have your physician contact IPATH via email. 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 will 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 work with your physician to initiate a phage hunt and guide them through the regulatory process. IPATH is a research and consultation program and we do not take over the care of patients who wish to pursue phage therapy. Our clinicians and staff are engaged as consultants to the treating physician(s) to advise on patient eligibility for phage therapy based on medical history and antibiogram results, support connection to phage testing and manufacturing facilities, and to offer guidance on the FDA’s (e/sp)IND application process.

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. We are unable to provide referrals.

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 (PDF) 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.

An antibiogram or antibiotic sensitivity report, is a test that physicians can order for a bacterial culture, which asks the microbiology lab to test which antibiotics the cultured bacteria is sensitive or resistant to.

Antibiograms are defined as a summary of antimicrobial susceptibility rates for selected bacterial pathogens, which provide comprehensive information about local antimicrobial resistance. Within health care facilities, this information is combined with clinical expertise to guide optimal antimicrobial treatment for patients with multidrug-resistant infections. Learn more about Antibiograms: http://publichealth.lacounty.gov/acd/antibiogram.htm

An antibiogram is used to show that a bacterial infection is resistant to some or all antibiotic options, which is typically a requirement for considering phage therapy. To obtain phage therapy through the FDA’s emergency IND route, a physician must demonstrate that all available treatment options (typically antibiotics and surgical procedures) have been exhausted, hence the need to use an experimental therapy such as phages.

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. Unfortunately, genetic sequencing tests (such as MicroGenDX) cannot be used to find active phages, and therefore cannot be a replacement for a bacterial culture. 

Since 2016, we have treated 21 patients at UC San Diego with multidrug-resistant (MDR) or device-related bacterial infections, including MDR Pseudomonas aeruginosa pneumonia, MDR Acinetobacter baumannii abdominal and cranial infections, MDR complicated urinary tract 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.

Additional great resource articles include one in Cell Review, Phage Therapy: From biological mechanisms to future directions.

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 or Single Patient Expanded Access IND from the FDA to administer bacteriophages and other products that have not completed the approval process. IPATH can assist with identifying phage labs and provide your doctor with advice about how to request and complete an IND submission if needed.

Currently, phage therapy programs exist in Belgium, France, Sweden, Australia and the UK. Phage therapy is standard-of-care in the Republic of Georgia and Poland.

If a clinical trial is an available option, this option should be pursued. Otherwise, IPATH has been treating patients with multidrug-resistant or device-related infections that have not responded to available treatments with phage therapy through the FDA’s Single Patient Expanded Access program. When a physician makes a Single Patient Expanded Access request to the FDA, they need to make an argument that all available treatments (antimicrobial and/or surgical) have been exhausted, justifying the need for the use of an unapproved therapy, such as phages.

Our lab and other phage labs charge fees to cover the expenses of finding, purifying, analyzing, and preparing the phage. Generally, these fees are at-cost amount needed to recover only what was spent in preparing the phage.

Typically, office visits and general health labs are covered by medical insurance. The out-of-pocket costs charged by a treating hospital can vary from institution to institution.

Local hospitals may charge the below costs to the patient:

• The cost of shipping bacterial isolates and phages
• Pharmacy supplies
• Pharmacy employee costs to prepare phages if needed
• The cost of phage-specific labs

1. If upon review of your medical history you become a phage therapy candidate under IPATH, your physician will need to send your bacterial isolate to a phage laboratory where our collaborators will determine if they have bacteriophage(s) in their phage library active against the bacterium or bacteria causing your illness. Most phage labs request that the patient’s purified isolate (streaked either on a petri dish, or as agar stab) be sent at room temperature via overnight shipping. The culture should be contained in a secondary container or sample bags suitable for biohazardous materials. The labs also request that any strain identification data be included in the shipment as well. This step usually takes 1-4 weeks once the bacterial isolates have been shipped. There is a possibility that matching phages will not be identified.
2. Once active phages have been identified (if they are found), they will need to be propagated, purified, and tested for endotoxin and sterility. This step usually takes 4-12 weeks. The phage labs work very hard to make sure your physician acquires the phage(s) as soon as possible for your treatment.
3. Once the phages are ready, IPATH or your physician will submit an Emergency or Single Patient Expanded Access IND application to U.S. Food and Drug Administration (FDA). If you are not being treated at UC San Diego, your physician will need to subsequently notify a local institutional review board (usually at the hospital) about the use of phage therapy according to the procedures outlined by the FDA’s IND process. We will be able to provide your physician with advice on how this is accomplished.
4. Once the FDA approves the IND, and the local IRB has been notified, the phage lab can ship the phage(s) to the treating hospital for phage administration. The dose and duration of treatment can vary with each unique patient and should be determined by the treating physician. IPATH physicians are available for treatment-plan consultations as well.