Table 4.
Overview of clinical trials investigating the safety and efficacy of phages or phage-derived enzymes in the treatment of (recalcitrant) rhinosinusitis.
| Authors (Year) | Study Type | Participants | Pathogen | Therapeutic Regimen | Phage | Safety | Efficacy |
|---|---|---|---|---|---|---|---|
| Mills E. et al. (1956) [22] |
OBS | Recalcitrant CRS (n = 60) | S. aureus | Nasal nebulizer | Phage lysate A-1 and B-7 | No reported AE | Clinical improvement: Excellent: 45%, Good: 33%, Fair: 17%, Poor: 5% |
| Weber-Dabrowska et al. (2000) [23] | OBS | Supparative sinusitis (n = 46) |
Different pathogen 1 | Oral or nasal drops, NS | Sensitive phage from collection, NS | NS | Clinical improvement: Full recovery: 83%, Marked: 7%, No effect: 11% |
| McCallin S. et al. (2018) [21] | OBS | Healthy carriers (n = 21) |
S. aureus | Oral (n = 10) or nasal application (n = 11) | Staphylococcal monophage (n = 21), Pyophage cocktail (n = 21), Placebo (n = 21) |
No reported AE after nasal therapy, mild AE 2 in 4 subjects after oral therapy. No changes in blood values. |
NS |
| Kryukov A. et al. (2019) [25] | RCT | Acute maxillary sinusitis (n = 58) |
Different pathogen 3 | Peroperative nasal rinsing, followed by oral treatment (n = 38); Second generation cephalosporin (n = 20) | Polyvalent Pyophage | No reported AE | Clinical improvement: No significant changes between both groups after 10 days of treatment |
| Ooi M. et al. (2019) [10] | OBS | Recalcitrant CRS (n = 9) | S. aureus | Intranasal high-volume irrigations | AB-SA01, cocktail | Mild AE 4 in 3 patients, all of them resolved by the end of the trial. No changes in vital signs or blood values. | Improved LKS in all patients. Reduction bacterial load: 100%. Eradication bacteria: 22% |
| Lusiak M. et al. (2020) [24] | OBS | CRS (n = 25) | Different pathogen 5 | Nasal (n = 4) or nasal + oral application (n = 21) | Sensitive phage from collection | NS | Clinical response: Positive: 32%, inadequate: 68% |
Abbreviations: OBS = observational study; RCT = randomized controlled trial; CRS = chronic rhinosinusitis; AE = adverse events; n = number; NS: not specified; LKS = Lund-Kennedy Score. 1 Different pathogen including S. aureus, E. coli, Klebsiella, Proteus and P. aeruginosa. 2 Mild adverse events including vomiting, loose stool, gastric acidity, mild epigastric pain and low grade fever. 3 Different pathogens including S. pneumoniae, S. aureus, H. influenzae and hemolytic streptococci. 4 Mild adverse events including diarrhea, epistaxis, oropharyngeal pain, cough and rhinalgia. 5 Different pathogen including S. aureus, P. aeruginosa, Klebsiella pneumoniae and E. coli.