In this category, we grouped phages (the natural predators of bacteria), phage enzymes and other phage derivatives; we also included non-pathogenic bacterial colonization of medical devices as a preventive strategy. Biological agents represent 18.1% of the basic research reviews retrieved from Pubmed.gov and less of 2.1% of clinical trials. Despite all the advantages proposed in the literature, we did not find any trials investigating phages as antibiofilm tools [i,ii]. Innovative approaches based on biological agents require a robust, standardized global regulatory framework to ensure high safety standards, quality and efficacy for clinical use.
It is necessary that scientists and clinicians continue to cooperate to translate new research areas in concretely applicable strategies in the clinical practice. One critical point to address is adequate phage characterization. Detailed reports on formulations, dosing and efficacy are also required. One of the main limits of phage therapy remains the stronger impact and efficacy on monomicrobial diseases than on polymicrobial infections due to the species specificity and narrow bacterial host range displayed by phages [iii].
Harro, J.M.; Peters, B.M.; O’May, G.A.; Archer, N.; Kerns, P.; Prabhakara, R.; Shirtliff, M.E. Vaccine development in Staphylococcus aureus: taking the biofilm phenotype into consideration. FEMS Immunol. Med. Microbiol. 2010, 59(3):306-323.
Maciejewska, B.; Olszak, T.; Drulis-Kawa, Z. Applications of bacteriophages versus phage enzymes to combat and cure bacterial infections: an ambitious and also a realistic application? Appl. Microbiol. Biotechnol. 2018, 102(6): 2563-2581.
Furfaro, L.L., Payne, M.S.; Chang, B.J. Bacteriophage therapy: clinical trials and regulatory hurdles. Front. Cell. Infect. Microbiol. 2018, 8: 376.