Experimental Phage Therapy of Bacterial Infections

NCT00945087 | Unknown

• 1 other identifier: OTF-1
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Bacterial Infections

Keywords

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

Interventions

Bacteriophage preparation OTHER

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.

Also known as: Phage preparation, bacteriophage formulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institute of Immunology and Experimental Therapy of the Polish Academy of Sciences: lead

Study Sites (1)

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

Wroclaw, 53-114, Poland

RECRUITING

Related Publications (1)

• 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.

  PMID: 22748809 RESULT

Related Links

• 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

MeSH Terms

Conditions

Bacterial Infections

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections

Study Officials

• Andrzej Górski, M.D. Ph.D.

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

  STUDY DIRECTOR

Central Study Contacts

Andrzej Górski, M.D. Ph.D.

CONTACT

+48 71-3709905; agorski@ikp.pl

Ryszard Międzybrodzki, M.D. Ph.D.

CONTACT

+48 71-3709901; cm@iitd.pan.wroc.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 21, 2009
• First Posted: July 23, 2009
• Study Start: December 1, 2005
• Last Updated: September 6, 2013

Record last verified: 2013-08

Locations

PL (1)