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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

97 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-02

Study Completion Date

2018-12-14

Brief Summary

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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.

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Detailed Description

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Conditions

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Intravesical Bacteriophage Treatment for Urinary Tract Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Anbiotica

Group Type ACTIVE_COMPARATOR

Antibiotics

Intervention Type DRUG

Oral application

Bacteriophages

Group Type ACTIVE_COMPARATOR

PYO Phage

Intervention Type BIOLOGICAL

Intravescial instillation

Placebo

Group Type PLACEBO_COMPARATOR

Sterile bacteriology media

Intervention Type OTHER

Sterile bacteriology media, with identical color as bacteriophage preparation

Interventions

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PYO Phage

Intravescial instillation

Intervention Type BIOLOGICAL

Antibiotics

Oral application

Intervention Type DRUG

Sterile bacteriology media

Sterile bacteriology media, with identical color as bacteriophage preparation

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No