Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Urinary tract infections are among the most prevalent microbial diseases and their financial burden on society is substantial. The use of bacteriophages against bacterial pathogens has gained over the last years a renewed interest, because of the continuing increase in antibiotic resistance worldwide. Thus, the aim of this study is to investigate the efficacy of intravesical bacteriophage treatment to normalize urine culture compared to intravesical placebo or standard antibiotic treatment in a randomized controlled trial following a pilot phase.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anbiotica | Active Comparator |
| |
| Bacteriophages | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PYO Phage | Biological | Intravescial instillation |
| |
| Antibiotics |
| Measure | Description | Time Frame |
|---|---|---|
| Normalisation of urine culture | Success of intravesical treatment, defined as normalization of urine culture (no evidence of bacteria, i.e. <104 colony forming units/mL) after 7 days of bacteriophage, placebo, or antibiotic treatment | 7 days after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Urine culture | Baseline and 7 days after treatment | |
| Bladder diary | Assessment of number of voids, number of leakages, post void residual | Baseline and 7 days after treatment |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Center of Urology | Tbilisi | Georgia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32949500 | Derived | Leitner L, Ujmajuridze A, Chanishvili N, Goderdzishvili M, Chkonia I, Rigvava S, Chkhotua A, Changashvili G, McCallin S, Schneider MP, Liechti MD, Mehnert U, Bachmann LM, Sybesma W, Kessler TM. Intravesical bacteriophages for treating urinary tract infections in patients undergoing transurethral resection of the prostate: a randomised, placebo-controlled, double-blind clinical trial. Lancet Infect Dis. 2021 Mar;21(3):427-436. doi: 10.1016/S1473-3099(20)30330-3. Epub 2020 Sep 16. | |
| 28950849 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
Oral application |
|
| Sterile bacteriology media | Other | Sterile bacteriology media, with identical color as bacteriophage preparation |
|
| Pain diary | Visual analog scale (0 (no pain) to 10 (strongest possible pain)) | Baseline and 7 days after treatment |
| IPSS questionnaire | Baseline and 7 days after treatment |
| Derived |
| Leitner L, Sybesma W, Chanishvili N, Goderdzishvili M, Chkhotua A, Ujmajuridze A, Schneider MP, Sartori A, Mehnert U, Bachmann LM, Kessler TM. Bacteriophages for treating urinary tract infections in patients undergoing transurethral resection of the prostate: a randomized, placebo-controlled, double-blind clinical trial. BMC Urol. 2017 Sep 26;17(1):90. doi: 10.1186/s12894-017-0283-6. |
| ID | Term |
|---|---|
| D000900 | Anti-Bacterial Agents |
| ID | Term |
|---|---|
| D000890 | Anti-Infective Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
Not provided
Not provided