Experimental Phage Therapy of Bacterial Infections
Recruitment status was Recruiting
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Purpose
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, urinary, or reproductive tract infections in whom extensive antibiotic therapy failed or the use of the targeted drug is contraindicated.
| Condition | Intervention |
|---|---|
|
Bacterial Infections |
Other: Bacteriophage preparation |
| Study Type: | Interventional |
| Official Title: | Experimental Phage Therapy of Drug-resistant Bacterial Infections, Including MRSA Infections |
-
Other: Bacteriophage preparation
Bacterial infections of different tissues and organs that prove incurable by antibiotics are a serious clinical problem. Bacteriophages (phages) are bacterial viruses which attack, multiply within, and then destroy bacteria. They can efficiently destroy bacteria which have acquired resistance to antibiotics and which cause life-threatening infections. The method of treating bacterial infections using phages has been known since the beginning of the 20th century. This 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 available therapy exists or the use of the targeted drug is contraindicated. It is not a research study.
The phage 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, specific phage preparations that are active against the pathogenic bacterial strain isolated from the patient are used for the treatment.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
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
- Signed informed consent
- Antibiotic therapy-resistant, chronic, symptomatic bacterial infection of the skin, subcutaneous tissue, bone, bone marrow, joints, fistulas, wounds, bedsores, urinary or reproductive tracts, 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, or Burkholderia 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, or Burkholderia
- The presence 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 in anamnesis
- A health condition which does not allow conducting the experimental therapy in the opinion of the qualifying physician
Contacts and Locations| Poland | |
| Phage Therapy Unit at the Institute of Immunology and Experimental Therapy of the Polish Academy of Sciences | Recruiting |
| Wrocław, Poland, 53-114 | |
| Contact: Andrzej Górski, M.D. Ph.D. 48 71-3709905 agorski@ikp.pl | |
| Contact: Ryszard Międzybrodzki, M.D. Ph.D. +48 71-3709901 nzoz@iitd.pan.wroc.pl | |
| Principal Investigator: Andrzej Górski, M.D. Ph.D. | |
| Sub-Investigator: Ryszard Międzybrodzki, M.D. Ph.D. | |
| Sub-Investigator: Wojciech Fortuna, M.D. | |
| Sub-Investigator: Krzysztof Szufnarowski, M.D. | |
| Sub-Investigator: Zdzisław Pawełczyk, M.D. | |
| Sub-Investigator: Sławomir Letkiewicz, M.D. Ph.D. | |
| Sub-Investigator: Beata Weber-Dąbrowska, Ph.D. | |
| Study Director: | Andrzej Górski, M.D. Ph.D. | Institute of Immunology and Experimental Therapy of the Polish Academy of Sciences |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00945087 History of Changes |
| Other Study ID Numbers: | OTF-1 |
| Study First Received: | July 21, 2009 |
| Last Updated: | May 25, 2010 |
| Health Authority: | Poland: Ethics Committee |
Keywords provided by Institute of Immunology and Experimental Therapy of the Polish Academy of Sciences:
|
bacteriophage bacteriophage preparation bacterial infection |
antibiotic-resistant infection multidrug-resistant bacteria MRSA |
Additional relevant MeSH terms:
|
Bacterial Infections |
ClinicalTrials.gov processed this record on June 18, 2013