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

NCT ID: NCT05402319

Last Updated: 2023-05-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-20
• Study Completion Date: 2025-09-01

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.

Conditions

Recurrent Urinary Tract Infections; Chronic Urinary-catheter-carrier; Biofilm Infection; Antibiotic Treatment; Replacement of Urinary Catheter

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Antibiotic monotherapy

Single antibiotic is given intravenously or orally (systemically).

Group Type: EXPERIMENTAL

Antibiotic combination therapy

Intervention Type: COMBINATION_PRODUCT

Anti-infective treatment with at least two different types of sensitive antibiotics.

Antibiotic combination therapy

At least two different antibiotics are given intravenously or orally.

Group Type: EXPERIMENTAL

Antibiotic combination therapy

Intervention Type: COMBINATION_PRODUCT

Anti-infective treatment with at least two different types of sensitive antibiotics.

Topical antibiotic therapy

Single antibiotic bladder irrigation.

Group Type: EXPERIMENTAL

Antibiotic combination therapy

Intervention Type: COMBINATION_PRODUCT

Anti-infective treatment with at least two different types of sensitive antibiotics.

Interventions

Antibiotic combination therapy

Anti-infective treatment with at least two different types of sensitive antibiotics.

Intervention Type: COMBINATION_PRODUCT

Other Intervention Names

Systemic versus topical antibiotic therapies

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Esbjerg Hospital - University Hospital of Southern Denmark

OTHER

Sponsor Role: collaborator

University of Southern Denmark

OTHER

Sponsor Role: lead

Responsible Party

Zhijun Song

Chief Physician, Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Zhijun Song, M.D., Ph.D.

Role: CONTACT

Zhijun.Song@rsyd.dk

+45 41586848

Other Identifiers

Projekt-ID: S-20190083G CSF

Identifier Type: -

Identifier Source: org_study_id