Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
INTERVENTIONAL
2005-12-31
Brief Summary
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Detailed Description
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The bacteriophage preparations which are used in the treatment procedures contain phages from the Bacteriophage Collection of the Institute of Immunology and Experimental Therapy of the Polish Academy of Sciences in Wrocław. For each patient only specific formulations of single phage or a phage mixture that are active against the pathogenic bacterial strain or strains isolated from the patient are used for the treatment.The isolation of live bacterial pathogen from the patient is necessary to carry out a phage-typing procedure to determine if the preparation of an active formulation is possible which is a prerequisite for receiving the treatment.
Conditions
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Keywords
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Interventions
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Bacteriophage preparation
Bacteriophage lysates or purified phage formulations containing phages lytic for Staphylococcus, Enterococcus, Pseudomonas, Escherichia, Klebsiella, Proteus, Citrobacter, Acinetobacter, Serratia, Morganella, Shigella, Salmonella, Enterobacter, Stenotrophomonas, or Burkholderia strains isolated from a patient used for oral, rectal and/or topical application.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Institute of Immunology and Experimental Therapy of the Polish Academy of Sciences
OTHER
Principal Investigators
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Andrzej Górski, M.D. Ph.D.
Role: STUDY_DIRECTOR
Institute of Immunology and Experimental Therapy of the Polish Academy of Sciences
Locations
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Phage Therapy Unit at the Institute of Immunology and Experimental Therapy of the Polish Academy of Sciences
Wroclaw, , Poland
Countries
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Central Contacts
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References
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Miedzybrodzki R, Borysowski J, Weber-Dabrowska B, Fortuna W, Letkiewicz S, Szufnarowski K, Pawelczyk Z, Rogoz P, Klak M, Wojtasik E, Gorski A. Clinical aspects of phage therapy. Adv Virus Res. 2012;83:73-121. doi: 10.1016/B978-0-12-394438-2.00003-7.
Related Links
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Click here for more information about this study: Experimental phage therapy of drug-resistant bacterial infections, including MRSA infections (in Polish)
Bacteriophage research and therapy
Other Identifiers
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OTF-1
Identifier Type: -
Identifier Source: org_study_id