Bacterial InfectionsNCT00945087
Experimental Phage Therapy of Bacterial Infections
A study testing Bacteriophage preparation in people with Bacterial Infections, run by Institute of Immunology and Experimental Therapy of the Polish Academy of Sciences at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bacterial Infections
- What is being tested?
- Bacteriophage preparation
- Type of treatment
- Pill or oral medicine
- How many people
- Not given
- Where
- 1 sitePoland
- Study dates
- Dec 2005to not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Phage Therapy Unit at the Institute of Immunology and Experimental Therapy of the Polish Academy of Sciences
Wroclaw, 53-114
Andrzej Górski, M.D. Ph.D.
Ryszard Międzybrodzki, M.D. Ph.D.
About this study
Official title: Experimental Phage Therapy of Drug-resistant Bacterial Infections, Including MRSA Infections
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.
Read the 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.
- Conditions
- Bacterial Infections
- Being tested
- Bacteriophage preparation
- Keywords
- bacteriophage, bacteriophage preparation, bacterial infection, antibiotic-resistant infection, multidrug-resistant bacteria, MRSA
- Medical subject headings
- Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bacteriophage preparationOther
Also called Phage preparation, bacteriophage formulation
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2009 (estimated)
- Study startDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bacterial InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
Sponsor and investigators
- Lead sponsor
- Institute of Immunology and Experimental Therapy of the Polish Academy of Sciences
- Sponsor type
- University, hospital or other
- Investigators
- Andrzej Górski, M.D. Ph.D., Study director, Institute of Immunology and Experimental Therapy of the Polish Academy of Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00945087
- Sponsor's protocol ID
- OTF-1
- Status last verified
- Aug 2013
- First submitted
- 21 Jul 2009
- Last updated
- 6 Sep 2013
- Results posted
- No
Publications
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.
PubMed 22748809
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Experimental Phage Therapy of Drug-resistant Bacterial Infections, Including MRSA Infections
- ClinicalTrials.gov ID
- NCT00945087
- Acronym / sponsor ID
- OTF-1
- Conditions
- Bacterial Infections
- Keywords
- bacteriophage, bacteriophage preparation, bacterial infection, antibiotic-resistant infection, multidrug-resistant bacteria, MRSA
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Institute of Immunology and Experimental Therapy of the Polish Academy of SciencesUniversity, hospital or other
- Study start
- Dec 2005
- First posted
- 23 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bacteriophage preparationAlso: Phage preparation, bacteriophage formulationBacteriophage 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 | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2013.
- Results publication: PubMed 22748809Miedzybrodzki 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.
- Click here for more information about this study: Experimental phage therapy of drug-resistant bacterial infections, including MRSA infections (in Polish)Link provided by the sponsor.
- Bacteriophage research and therapyLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrzej Górski, M.D. Ph.D. study director
Institute of Immunology and Experimental Therapy of the Polish Academy of Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bacteriophage preparation in people with Bacterial Infections, run by Institute of Immunology and Experimental Therapy of the Polish Academy of Sciences at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrzej Górski, M.D. Ph.D. (+48 71-3709905, agorski@ikp.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00945087, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2013; AzTrials last refreshed its copy on 6 Nov 2026.