Bacteriophages for Treating Urinary Tract Infections in Patients Undergoing Transurethral Resection of the Prostate

NCT03140085 | Completed Phase 2

• 1 other identifier: 02/283
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Intravesical Bacteriophage Treatment for Urinary Tract Infections

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Urine culture

  Baseline and 7 days after treatment

• Bladder diary

  Baseline and 7 days after treatment

• Pain diary

  Baseline and 7 days after treatment

• IPSS questionnaire

  Baseline and 7 days after treatment

Study Arms (3)

Anbiotica

ACTIVE COMPARATOR

Drug: Antibiotics

Bacteriophages

ACTIVE COMPARATOR

Biological: PYO Phage

Placebo

PLACEBO COMPARATOR

Other: Sterile bacteriology media

Interventions

PYO Phage BIOLOGICAL

Intravescial instillation

Bacteriophages

Antibiotics DRUG

Oral application

Anbiotica

Sterile bacteriology media OTHER

Sterile bacteriology media, with identical color as bacteriophage preparation

Placebo

Eligibility Criteria

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

You may qualify if:

• Patients with urinary tract infections who are scheduled for transurethral resection of the prostate with urine culture (taken by mid-stream urine; or from the existing transurethral or suprapubic catheter) ≥104 colony forming units /mL of predefined uropathogens, including Enterococcus spp., Escherichia coli, Proteus mirabilis, Pseudomonas aeruginosa, Staphylococcus spp., and Streptococcus spp. and lower urinary tract symptoms such as urgency, frequency, dysuria, increased number of incontinence episodes
• Written informed consent.

You may not qualify if:

• Fever \>38°C
• CRP \>100mg/L
• Acute prostatitis
• Concomitant fungal urinary tract infection
• Current antibiotic treatment or antibiotic treatment within the last 7 days (exceptions: subjects with an active catheter associated urinary tract infection who have received prior antibiotics may be enrolled provided a minimum of 48 hours has elapsed between the last dose of the prior antibiotic and the time of obtaining the baseline urine specimen. Subjects receiving current antibiotic prophylaxis for catheter associated urinary tract infection who present signs and symptoms consistent with an active new catheter associated infection may be enrolled provided all other eligibility criteria are met including obtaining a pre-treatment qualifying baseline urine culture)
• Any rapidly progressing disease or immediately life-threatening illness including but not limited to: acute hepatic failure, respiratory failure, and septic shock
• No informed consent

Sponsors & Collaborators

• Balgrist University Hospital: lead

Study Sites (1)

National Center of Urology

Tbilisi, Georgia

Location

Related Publications (2)

• 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.

  PMID: 32949500 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.

  PMID: 28950849 DERIVED

MeSH Terms

Interventions

Anti-Bacterial Agents

Intervention Hierarchy (Ancestors)

Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: April 27, 2017
• First Posted: May 4, 2017
• Study Start: June 2, 2017
• Primary Completion: December 14, 2018
• Study Completion: December 14, 2018
• Last Updated: March 21, 2019

Record last verified: 2019-03

Locations

GE (1)