Experimental Phage Therapy of Bacterial Infections
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|ClinicalTrials.gov Identifier: NCT00945087|
Recruitment Status : Unknown
Verified August 2013 by Institute of Immunology and Experimental Therapy of the Polish Academy of Sciences.
Recruitment status was: Recruiting
First Posted : July 23, 2009
Last Update Posted : September 6, 2013
|Condition or disease||Intervention/treatment||Phase|
|Bacterial Infections||Other: Bacteriophage preparation||Not Applicable|
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 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.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Experimental Phage Therapy of Drug-resistant Bacterial Infections, Including MRSA Infections|
|Study Start Date :||December 2005|
- Other: 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 Name: Phage preparation, bacteriophage formulation
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00945087
|Contact: Andrzej Górski, M.D. Ph.D.||+48 firstname.lastname@example.org|
|Contact: Ryszard Międzybrodzki, M.D. Ph.D.||+48 email@example.com|
|Phage Therapy Unit at the Institute of Immunology and Experimental Therapy of the Polish Academy of Sciences||Recruiting|
|Wrocław, Poland, 53-114|
|Principal Investigator: Andrzej Górski, M.D. Ph.D.|
|Sub-Investigator: Ryszard Międzybrodzki, M.D. Ph.D.|
|Sub-Investigator: Wojciech Fortuna, M.D. Ph.D.|
|Sub-Investigator: Krzysztof Szufnarowski, M.D.|
|Sub-Investigator: Sławomir Letkiewicz, M.D. Ph.D.|
|Sub-Investigator: Beata Weber-Dąbrowska, Ph.D.|
|Sub-Investigator: Paweł Rogóż, M.D.|
|Study Director:||Andrzej Górski, M.D. Ph.D.||Institute of Immunology and Experimental Therapy of the Polish Academy of Sciences|