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

NCT05402319 | Unknown DMC

• 1 other identifier: Projekt-ID: S-20190083G CSF
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (5)

• 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.

  3 days

• Infection control

  Higher body temperature (more than 37.5 degrees) recover to normal (between 36 - 37 degrees).

  Less than 3 days

• 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.

  Less than or equal to 5 days

• Infection control

  C-reactive protein (CRP) reduced from significantly higher than 10 mg/L to less than 10 mg/L.

  Less than or equal to 5 days

• Infection control

  Estimated glomerular filtration rate (eGFR) recovered from less than 60 mL/min/1,73 m2 to equal to 60 or higher.

  Less than or equal to 5 days

Secondary Outcomes (1)

• UTI recurrence expectation

  One month

Study Arms (3)

Antibiotic monotherapy

EXPERIMENTAL

Single antibiotic is given intravenously or orally (systemically).

Combination Product: Antibiotic combination therapy

Antibiotic combination therapy

EXPERIMENTAL

At least two different antibiotics are given intravenously or orally.

Combination Product: Antibiotic combination therapy

Topical antibiotic therapy

EXPERIMENTAL

Single antibiotic bladder irrigation.

Combination Product: Antibiotic combination therapy

Interventions

Antibiotic combination therapy COMBINATION_PRODUCT

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

Also known as: Systemic versus topical antibiotic therapies

Antibiotic combination therapy; Antibiotic monotherapy; Topical antibiotic therapy

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Southern Denmark: lead
• Esbjerg Hospital - University Hospital of Southern Denmark: collaborator

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

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

CONTACT

+45 41586848; Zhijun.Song@rsyd.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician, Associate Professor

Model Details: 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).

Study Record Dates

• First Submitted: May 16, 2022
• First Posted: June 2, 2022
• Study Start: June 20, 2023
• Primary Completion: March 31, 2025
• Study Completion: September 1, 2025
• Last Updated: May 10, 2023

Record last verified: 2023-05