Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2020 Aug 27;7(9):ofaa389.
doi: 10.1093/ofid/ofaa389. eCollection 2020 Sep.

Lessons Learned From the First 10 Consecutive Cases of Intravenous Bacteriophage Therapy to Treat Multidrug-Resistant Bacterial Infections at a Single Center in the United States

Saima Aslam  1   2 , Elizabeth Lampley  2 , Darcy Wooten  1 , Maile Karris  1 , Constance Benson  1   2 , Steffanie Strathdee  1   2 , Robert T Schooley  1   2
Affiliations

Lessons Learned From the First 10 Consecutive Cases of Intravenous Bacteriophage Therapy to Treat Multidrug-Resistant Bacterial Infections at a Single Center in the United States

Saima Aslam et al. Open Forum Infect Dis. .

Abstract

Background: Due to increasing multidrug-resistant (MDR) infections, there is an interest in assessing the use of bacteriophage therapy (BT) as an antibiotic alternative. After the first successful case of intravenous BT to treat a systemic MDR infection at our institution in 2017, the Center for Innovative Phage Applications and Therapeutics (IPATH) was created at the University of California, San Diego, in June 2018.

Methods: We reviewed IPATH consult requests from June 1, 2018, to April 30, 2020, and reviewed the regulatory process of initiating BT on a compassionate basis in the United States. We also reviewed outcomes of the first 10 cases at our center treated with intravenous BT (from April 1, 2017, onwards).

Results: Among 785 BT requests to IPATH, BT was administered to 17 of 119 patients in whom it was recommended. One-third of requests were for Pseudomonas aeruginosa, Staphylococcus aureus, and Mycobacterium abscessus. Intravenous BT was safe with a successful outcome in 7/10 antibiotic-recalcitrant infections at our center (6 were before IPATH). BT may be safely self-administered by outpatients, used for infection suppression/prophylaxis, and combined successfully with antibiotics despite antibiotic resistance, and phage resistance may be overcome with new phage(s). Failure occurred in 2 cases despite in vitro phage susceptibility.

Conclusions: We demonstrate the safety and feasibility of intravenous BT for a variety of infections and discuss practical considerations that will be critical for informing future clinical trials.

Keywords: bacteriophage therapy; multidrug-resistant infections; phage therapy.

PubMed Disclaimer

Figures

Figure 1.
Figure 1.
Flowchart depicting outcome of all bacteriophage therapy requests at the Center for Innovative Phage Applications and Therapeutics. Abbreviation: IPATH, Center for Innovative Phage Applications and Therapeutics.
Figure 2.
Figure 2.
Timeline of the process to initiate bacteriophage therapy for a patient on a compassionate use basis in the United States. Abbreviations: FDA, Food and Drug Administration; IND, Investigational New Drug; IRB, institutional review board.
See this image and copyright information in PMC

References

    1. Green S, Ma L, Maresso A. Phage therapy. In: Schmidt T, ed. Encyclopedia of Microbiology. 4th ed. Amsterdam, Netherlands: Elsevier; 2019:485–95.
    1. Schooley RT, Biswas B, Gill JJ, et al. Development and use of personalized bacteriophage-based therapeutic cocktails to treat a patient with a disseminated resistant Acinetobacter baumannii infection. Antimicrob Agents Chemother. 2017; 61:e00954-17. - PMC - PubMed
    1. Henry M, Biswas B, Vincent L, et al. Development of a high throughput assay for indirectly measuring phage growth using the OmniLog™ system. Bacteriophage 2012; 2:159–67. - PMC - PubMed
    1. Kropinski AM, Mazzocco A, Waddell TE, Lingohr E, Johnson RP. Enumeration of bacteriophages by double agar overlay plaque assay. Methods Mol Biol 2009; 501:69–76. - PubMed
    1. Torres-Barceló C. The disparate effects of bacteriophages on antibiotic-resistant bacteria. Emerg Microbes Infect 2018; 7:168–79. - PMC - PubMed