Programs and studies

Clinical study

Experimental Phage Therapy of Bacterial Infections

StatusStatus unconfirmed
TypeTrial
CountriesPoland
Conditions studiedBacterial Infections
Study yearsStarted 2005
Entry review2026-10-03

Participation

Check the study record or contact the study team for current recruitment and eligibility.

Study eligibility

Inclusion Criteria: * 18 years of age or over. * Men and women of reproductive age must use contraception during and one month after the therapy. Women of reproductive age must have negative result of a pregnancy test before beginning of the treatment. * Signed informed consent. * Antibiotic therapy-resistant, chronic, symptomatic bacterial infection of the skin, subcutaneous tissue, bone, bone marrow, joints, fistulas, wounds, bedsores, genital and/or urinary tract, digestive tract, middle ear, sinuses, tonsils, upper and lower respiratory tract, or a state in which a targeted antibiotic therapy is impossible to carry out due to other medical reasons. * A putative pathogenic bacteria such as Staphylococcus, Enterococcus, Escherichia, Citrobacter, Enterobacter, Klebsiella, Shigella, Salmonella, Serratia, Proteus, Pseudomonas, Stenotrophomonas, Acinetobacter, Burkholderia, or Morganella present in the site of the said infection as confirmed by the result of microbiological culture. * Ineffective antibiotic therapy of said infection and/or antibiogram-confirmed multidrug resistance of a putative pathogenic bacteria such as Staphylococcus, Enterococcus, Escherichia, Citrobacter, Enterobacter, Klebsiella, Shigella, Salmonella, Serratia, Proteus, Pseudomonas, Stenotrophomonas, Acinetobacter, Burkholderia, or Morganella. * The presence in the Bacteriophage Collection of the Institute of Immunology and Experimental Therapy of the Polish Academy of Sciences of a phage able to lyse a bacterial strain cultured from a patient in the Bacteriophage Collection of the Institute of Immunology and Experimental Therapy of the Polish Academy of Sciences (positive result of a phage-typing procedure). Exclusion Criteria: * Pregnant or breastfeeding women. * Malabsorption syndrome, allergy to food or animal protein, or advanced hepatic insufficiency when it is impossible to apply the phage preparation using other route than oral. * Allergy to components of phage preparations. * A health condition which does not allow conducting the experimental therapy in the opinion of the qualifying physician.

Study description

The primary purpose of this experimental therapy is to treat, with the aid of bacteriophages, patients with non-healing postoperative wounds or bone, upper respiratory tract, genital or urinary tract infections in whom extensive antibiotic therapy failed or the use of the targeted drug is contraindicated.

Study registrations

ClinicalTrials.govNCT00945087
Recorded study locations (1)

Locations listed in the study record; this does not confirm current recruitment or treatment outside the study. A site label may be older than the overall study status.

Phage Therapy Unit at the Institute of Immunology and Experimental Therapy of the Polish Academy of Sciences

Wroclaw, Poland

Recorded site status: Recruiting. Study location source ↗

Sources and updates

Entry reviewed . This is the date of our source review, not a confirmation of availability today.

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Study ID
nct00945087