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
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
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
NCT ID
NCT05402319
First Posted
May 16, 2022
Last Updated
May 8, 2023
Sponsor
University of Southern Denmark
Collaborators
Hospital of South West Jutland
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
Learn more about this trial
Comparison of Three Different Antibiotic Treatments Against Recurrent Urinary Tract Infections in Catheterized Patients
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