The programme of the experimental treatment enables the use of phage preparations under the rules of a therapeutic experiment (on the basis of the respective Polish regulations) in cases where no effective therapy is available or the use of the targeted drug is contraindicated. The phage preparations which are used in the treatment procedures contain specific phages from the Bacteriophage Collection of the Institute of Immunology and Experimental Therapy of the Polish Academy of Sciences in Wroclaw which are active against the isolated pathogenic bacterial strain. These preparations can be used in adult patients infected only with bacteria belonging to the following genera:
However, not all the bacterial strains belonging to the above genera are sensitive to the phages in the institute’s collection.
The phage therapy protocol requires obligatory visits to Wroclaw during the therapy. The patients have to show up for qualification and for control visits (the first after 2 weeks of treatment and the next one after 2-4 weeks). A consultation usually lasts 2-3 hours. The phage preparations may be applied at home (for example as wet dressings or orally). The treatment lasts 6-8 weeks on average.
In the Phage Therapy Unit, which is an outpatient clinic, we have no possibilities to perform any specialized diagnostic procedures other than microbiological tests related to the phage therapy and blood and urine tests. Our standard procedure is that we seek additional advice from a medical specialist (particularly the recent one who made the diagnosis and treated the patient) on the need for non invasive treatment of infection and the application of diagnostic procedures, because some infections may be a manifestation of other diseases and in some cases an antibacterial treatment alone will not help. This helps us to avoid phage application in patients who require further diagnostics or a specialized conventional therapy (e.g. surgery). It also prevents disappointment and a repeat qualification visit, especially in patients who live in remote areas.
The phage typing procedure is necessary to determine whether the preparation of an active phage preparation is possible. We cannot qualify the patient if the result of phage typing is negative (which means we cannot prepare an active phage preparation); therefore it is possible to send to the Bacteriophage Laboratory of the IIET PAS the sample for phage typing before visiting the PTU.
The experimental phage therapy performed at the Phage Therapy Unit is not a standard clinical trial and its costs need to be covered.