TABLE 2.
Phage and phage lysin therapy in human clinical trials from January 2007 to March 2019
| Yr of trial start | Trial registration no. | Reference | Phage/lysin formulation (investigator/sponsor) | Bacteria or bacterium targeted | Treatment indication | Trial phase | Outcome |
|---|---|---|---|---|---|---|---|
| 2006 | NCT00663091 | 61 | WPP-201 cocktail (Southwest Regional Wound Care Center) | Escherichia coli, Pseudomonas aeruginosa, Staphylococcus aureus | Infected venous leg ulcers | I | No adverse effects observed |
| 2009 | NCT00937274 | 62, 66 | T4 coliphage cocktail: AB2, 4, 6, 11, 46, 50, 55, JS34, 37, 98, D1.4 (Nestlé) | E. coli | Dysentery | I/II | No adverse effects or benefit noted; study discontinued prematurely |
| 2009 | EudraCT 2004-001691-39 | 63 | Biophage-PA (Biocontrol Ltd.) | P. aeruginosa | Otitis externa | I/II | No adverse effects noted; at 42 days posttreatment, the phage-treated cohort exhibited reduced median bacterial abundance compared to placebo group |
| 2015 | NCT02116010 | 67 | PhagoBurn (Pherecydes Pharma) | P. aeruginosa, E. coli | Infected burn wounds | I/II | Fewer adverse effects noted in phage versus antibiotic treatment arms; median time to sustained bacterial reduction comparable between treatment groups by day 7; study prematurely discontinued |
| 2017 | NCT03089697 | NAa | SAL200 (Tonabacase; iNtRON Biotechnology) | S. aureus | Bacteremia | II | Ongoing |
| 2017 | NCT03163446 | 64 | Exebacase (CF-301; ContraFect Corp.) | S. aureus | Bacteremia, including endocarditis (single intravenous dose added to standard-of-care antibiotics) | II | Well tolerated; higher clinical response rate compared to antibiotics alone in methicillin-resistant S. aureus- but not methicillin-susceptible S. aureus-infected subgroups |
| 2017 | NCT03140085 | NA | Pyophage (Tzulakidze National Center of Urology) | Enterococcus species, E. coli, Proteus mirabilis, staphylococci, streptococci, P. aeruginosa | Urinary tract infections | II/III | Results pending (Thomas Kessler, personal communication) |
| 2019 | NCT03808103 | NA | EcoActive (Intralytix, Inc.) | Adherent invasive E. coli (AIEC) | Exacerbation of inflammation in Crohn disease secondary to AIEC | I/II | Recruitment ongoing |
| 2019 | NCT02664740 | NA | PhagoPied (Pherecydes Pharma) | S. aureus | Diabetic wounds | I/II | Not yet recruiting |
a
NA, not applicable.