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Comparison of Three Different Antibiotic Treatments Against Recurrent Urinary Tract Infections in Catheterized Patients

Primary Purpose

Recurrent Urinary Tract Infections, Chronic Urinary-catheter-carrier, Biofilm Infection

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Antibiotic combination therapy
Sponsored by
University of Southern Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Urinary Tract Infections focused on measuring chronic urinary-catheter-carrier, recurrent urinary tract infection, biofilm infections, multidrug-resistant bacteria, antibiotic monotherapy, combination therapy, bladder lavage, urinary catheter replacement

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients, who have long-term urinary catheter in situ with recurrent UTI and are admitted or referred to an ambulatory due to acute episode of UTI (acute local symptoms include pyuria or urine stick positive, suprapubic pain or tenderness, costovertebral angle pain or tenderness, catheter obstruction, or acute hematuria) or urosepsis (If a bacteriuric patient has positive blood culture with fever, leukocytosis and high C-reaction protein, and the cultured bacteria in urine and blood are consistent, urosepsis is diagnosed) will be included to the project.

Exclusion Criteria:

  • Patients with nephrostomy catheters, J-J catheter, bricker bladder or urinary stones will be excluded from the project.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    Antibiotic monotherapy

    Antibiotic combination therapy

    Topical antibiotic therapy

    Arm Description

    Single antibiotic is given intravenously or orally (systemically).

    At least two different antibiotics are given intravenously or orally.

    Single antibiotic bladder irrigation.

    Outcomes

    Primary Outcome Measures

    Infection control
    Local UTI symptoms (cloudy urine, hematuria, smelly urine, discomfort or pain in the lower abdomen or pubic symphysis) were significantly reduced or disappeared.
    Infection control
    Higher body temperature (more than 37.5 degrees) recover to normal (between 36 - 37 degrees).
    Infection control
    Blood leukocyte count reduced from more than 8,800 × 109/L (dominated by neutrophils) to between 4,000 to 8,800 x 109/L.
    Infection control
    C-reactive protein (CRP) reduced from significantly higher than 10 mg/L to less than 10 mg/L.
    Infection control
    Estimated glomerular filtration rate (eGFR) recovered from less than 60 mL/min/1,73 m2 to equal to 60 or higher.

    Secondary Outcome Measures

    UTI recurrence expectation
    Significant less UTI recurrence.

    Full Information

    First Posted
    May 16, 2022
    Last Updated
    May 8, 2023
    Sponsor
    University of Southern Denmark
    Collaborators
    Hospital of South West Jutland
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05402319
    Brief Title
    Comparison of Three Different Antibiotic Treatments Against Recurrent Urinary Tract Infections in Catheterized Patients
    Official Title
    Comparison of Systemic (Mono-/Combination Therapies) and Topical Antibiotic Treatments Against Recurrent Urinary Tract Infections (RUTI) Caused by Multidrug Resistant Bacteria in Catheterized Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 20, 2023 (Anticipated)
    Primary Completion Date
    March 31, 2025 (Anticipated)
    Study Completion Date
    September 1, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Southern Denmark
    Collaborators
    Hospital of South West Jutland

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Recurrent urinary tract infections (UTI) in the patients chronically catheterized are serious challenges clinically. The pathogens are often multidrug-resistant bacteria and such UTIs are actually biofilm infections. Currently standard antibiotic treatment against UTI in Denmark is sensitive antibiotic monotherapy. Theoretically antibiotic monotherapy is not a good treatment against biofilm infections. In the patients with impaired renal functions, both i.v. and p.o. antibiotic treatments function poor. Therefore, bladder lavage might help. In the study, the participants will be randomly divided into three groups (monotherapy, combination and bladder lavage). The investigators will evaluate the results and find a better treatment based on the clinical evidences, which might benefit the patients.
    Detailed Description
    Multidrug resistant bacterial infections are serious challenges that human beings are facing. Recurrent urinary tract infections (UTI) in the patients chronically catheterized is one of the examples. Urinary catheterization not only impair the urinary tract self-clean mechanism, but also provide the urinary pathogens an ideal surface to form bacterial biofilms, which have been demonstrated in vivo and in vitro impossible to be removed by only antibiotic treatments. Repeated antibiotic treatments could not help to remove urinary biofilm infections, but induction of antibiotic resistance. Currently treatment against recurrent UTI in urinary catheterized patients includes antibiotic treatment and replacement of urinary catheter. Antibiotic treatment aims to remove the planktonic bacteria, control clinical symptoms and localize the infection in urinary tract, which will help to limit the bacteria in the catheter biofilm and benefit the replacement of the infected catheter. At present, standard antibiotic treatment against UTI in catheter carriers is sensitive antibiotic monotherapy according to the Danish guidelines on the use of antibiotics in the website "https://pro.medicin.dk/". However, these kinds of UTIs are usually biofilm infections, especially the urinary pathogen are quite often multiple-resistant. Therefore, some of the hospitals prefer combination antibiotic treatments according to the results from biofilm in vivo and in vitro researches. There are currently always arguments regarding monotherapy and combination antibiotic treatments. The investigators intends to observe and compare both treatments and try to clarify their respective advantages and disadvantages, which will benefit the clinical treatments and control of the antibiotic resistance in future. In addition, some of the patients have poor renal function, which reduce significantly the antibiotic concentration in urine. In such situation, bladder-antibiotic lavage might help. In the study, the patients will be randomly divided into three groups (monotherapy, combination and bladder lavage). The investigators will evaluate the results and find a better treatment based on the clinical evidences, which might benefit the patients.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Recurrent Urinary Tract Infections, Chronic Urinary-catheter-carrier, Biofilm Infection, Antibiotic Treatment, Replacement of Urinary Catheter
    Keywords
    chronic urinary-catheter-carrier, recurrent urinary tract infection, biofilm infections, multidrug-resistant bacteria, antibiotic monotherapy, combination therapy, bladder lavage, urinary catheter replacement

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    The patients will be divided randomly into 3 individual groups: (1) systemic antibiotic monotherapy; (2) systemic antibiotic combination therapy; and (3) bladder antibiotic lavage (topical therapy).
    Masking
    Care ProviderInvestigatorOutcomes Assessor
    Masking Description
    There will be 150 patients involve in the study. The investigators have prepared 150 paper balls with numbers for the lottery. If the patient meets the inclusion criteria, the patient will be allowed to read the written instructions for invitation to participate in the study. The doctors and nurses will answer questions from patients. A signature is required if the patient agrees to participate in the study. The patient will then be allowed to draw a ball of paper, and the nurse or doctor will register the corresponding number in the computer. Patients 1-50 will be the first group, 51-100 the second group, and 101-150 the third group.
    Allocation
    Randomized
    Enrollment
    150 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Antibiotic monotherapy
    Arm Type
    Experimental
    Arm Description
    Single antibiotic is given intravenously or orally (systemically).
    Arm Title
    Antibiotic combination therapy
    Arm Type
    Experimental
    Arm Description
    At least two different antibiotics are given intravenously or orally.
    Arm Title
    Topical antibiotic therapy
    Arm Type
    Experimental
    Arm Description
    Single antibiotic bladder irrigation.
    Intervention Type
    Combination Product
    Intervention Name(s)
    Antibiotic combination therapy
    Other Intervention Name(s)
    Systemic versus topical antibiotic therapies
    Intervention Description
    Anti-infective treatment with at least two different types of sensitive antibiotics.
    Primary Outcome Measure Information:
    Title
    Infection control
    Description
    Local UTI symptoms (cloudy urine, hematuria, smelly urine, discomfort or pain in the lower abdomen or pubic symphysis) were significantly reduced or disappeared.
    Time Frame
    3 days
    Title
    Infection control
    Description
    Higher body temperature (more than 37.5 degrees) recover to normal (between 36 - 37 degrees).
    Time Frame
    Less than 3 days
    Title
    Infection control
    Description
    Blood leukocyte count reduced from more than 8,800 × 109/L (dominated by neutrophils) to between 4,000 to 8,800 x 109/L.
    Time Frame
    Less than or equal to 5 days
    Title
    Infection control
    Description
    C-reactive protein (CRP) reduced from significantly higher than 10 mg/L to less than 10 mg/L.
    Time Frame
    Less than or equal to 5 days
    Title
    Infection control
    Description
    Estimated glomerular filtration rate (eGFR) recovered from less than 60 mL/min/1,73 m2 to equal to 60 or higher.
    Time Frame
    Less than or equal to 5 days
    Secondary Outcome Measure Information:
    Title
    UTI recurrence expectation
    Description
    Significant less UTI recurrence.
    Time Frame
    One month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients, who have long-term urinary catheter in situ with recurrent UTI and are admitted or referred to an ambulatory due to acute episode of UTI (acute local symptoms include pyuria or urine stick positive, suprapubic pain or tenderness, costovertebral angle pain or tenderness, catheter obstruction, or acute hematuria) or urosepsis (If a bacteriuric patient has positive blood culture with fever, leukocytosis and high C-reaction protein, and the cultured bacteria in urine and blood are consistent, urosepsis is diagnosed) will be included to the project. Exclusion Criteria: Patients with nephrostomy catheters, J-J catheter, bricker bladder or urinary stones will be excluded from the project.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Zhijun Song, M.D., Ph.D.
    Phone
    +45 41586848
    Email
    Zhijun.Song@rsyd.dk

    12. IPD Sharing Statement

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    Comparison of Three Different Antibiotic Treatments Against Recurrent Urinary Tract Infections in Catheterized Patients

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