Experimental Phage Therapy of Bacterial Infections

The recruitment status of this study is unknown because the information has not been verified recently.

Verified May 2010 by Institute of Immunology and Experimental Therapy of the Polish Academy of Sciences. Recruitment status was Recruiting

First Received on July 21, 2009. Last Updated on May 25, 2010 History of Changes

Sponsor:	Institute of Immunology and Experimental Therapy of the Polish Academy of Sciences
Information provided by:	Institute of Immunology and Experimental Therapy of the Polish Academy of Sciences
ClinicalTrials.gov Identifier:	NCT00945087

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

Resource links provided by NLM:

MedlinePlus related topics: Bacterial Infections

U.S. FDA Resources

Further study details as provided by Institute of Immunology and Experimental Therapy of the Polish Academy of Sciences:

Intervention Details:

Bacteriophage lysates containing phages lytic for Staphylococcus, Enterococcus, Escherichia, Citrobacter, Enterobacter, Klebsiella, Shigella, Salmonella, Serratia, Proteus, Pseudomonas, Stenotrophomonas, Acinetobacter, or Burkholderia strains isolated from a patient used for oral or topical application.

Other Name: Phage preparation, phage lysate

Detailed Description:

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

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00945087

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.

Sponsors and Collaborators

Institute of Immunology and Experimental Therapy of the Polish Academy of Sciences

Investigators

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 May 24, 2012