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Experimental Phage Therapy of Bacterial Infections

Primary Purpose

Bacterial Infections

Status

Unknown status

Phase

Not Applicable

Locations

Poland

Study Type

Interventional

Intervention

Bacteriophage preparation

About this trial

This is an interventional trial for Bacterial Infections focused on measuring bacteriophage, bacteriophage preparation, bacterial infection, antibiotic-resistant infection, multidrug-resistant bacteria, MRSA

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00945087

First Posted

July 21, 2009

Last Updated

September 5, 2013

Sponsor

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

1. Study Identification

Unique Protocol Identification Number

NCT00945087

Brief Title

Experimental Phage Therapy of Bacterial Infections

Official Title

Experimental Phage Therapy of Drug-resistant Bacterial Infections, Including MRSA Infections

Study Type

Interventional

2. Study Status

Record Verification Date

August 2013

Overall Recruitment Status

Unknown status

Study Start Date

December 2005 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

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

4. Oversight

5. Study Description

Brief Summary

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.

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bacterial Infections

Keywords

bacteriophage, bacteriophage preparation, bacterial infection, antibiotic-resistant infection, multidrug-resistant bacteria, MRSA

7. Study Design

Study Phase

Not Applicable

8. Arms, Groups, and Interventions

Intervention Type

Other

Intervention Name(s)

Bacteriophage preparation

Other Intervention Name(s)

Phage preparation, bacteriophage formulation

Intervention Description

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.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Andrzej Górski, M.D. Ph.D.

Phone

+48 71-3709905

agorski@ikp.pl

First Name & Middle Initial & Last Name or Official Title & Degree

Ryszard Międzybrodzki, M.D. Ph.D.

Phone

+48 71-3709901

cm@iitd.pan.wroc.pl

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Andrzej Górski, M.D. Ph.D.

Organizational Affiliation

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

Official's Role

Study Director

Facility Information:

Facility Name

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

City

Wrocław

ZIP/Postal Code

53-114

Country

Poland

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Andrzej Górski, M.D. Ph.D.

First Name & Middle Initial & Last Name & Degree

Ryszard Międzybrodzki, M.D. Ph.D.

First Name & Middle Initial & Last Name & Degree

Wojciech Fortuna, M.D. Ph.D.

First Name & Middle Initial & Last Name & Degree

Krzysztof Szufnarowski, M.D.

First Name & Middle Initial & Last Name & Degree

Sławomir Letkiewicz, M.D. Ph.D.

First Name & Middle Initial & Last Name & Degree

Beata Weber-Dąbrowska, Ph.D.

First Name & Middle Initial & Last Name & Degree

Paweł Rogóż, M.D.

12. IPD Sharing Statement

Citations:

PubMed Identifier

22748809

Citation

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.

Results Reference

result

Links:

URL

http://surfer.iitd.pan.wroc.pl/pl/OTF/

Description

Click here for more information about this study: Experimental phage therapy of drug-resistant bacterial infections, including MRSA infections (in Polish)

URL

http://surfer.iitd.pan.wroc.pl/en/Phages/

Description

Bacteriophage research and therapy

Learn more about this trial

Experimental Phage Therapy of Bacterial Infections

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