Recurrent Urinary Tract InfectionsNCT05402319
Comparison of Three Different Antibiotic Treatments Against Recurrent Urinary Tract Infections in Catheterized Patients
A study testing Antibiotic combination therapy in people with Recurrent Urinary Tract Infections and Chronic Urinary-catheter-carrier, run by University of Southern Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Urinary Tract Infections, Chronic Urinary-catheter-carrier, Biofilm Infection
- What is being tested?
- Antibiotic combination therapy
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 20 Jun 2023to 1 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients with nephrostomy catheters, J-J catheter, bricker bladder or urinary stones will be excluded from the project.
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
Read the 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
- Being tested
- Antibiotic combination therapy
- Keywords
- chronic urinary-catheter-carrier, recurrent urinary tract infection, biofilm infections, multidrug-resistant bacteria, antibiotic monotherapy, combination therapy, bladder lavage, urinary catheter replacement
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antibiotic combination therapyCombination product
Also called Systemic versus topical antibiotic therapies
Anti-infective treatment with at least two different types of sensitive antibiotics.
| Study group | Role | What they receive |
|---|---|---|
| Antibiotic monotherapy | Experimental | Single antibiotic is given intravenously or orally (systemically). Receives: Combination Product: Antibiotic combination therapy |
| Antibiotic combination therapy | Experimental | At least two different antibiotics are given intravenously or orally. Receives: Combination Product: Antibiotic combination therapy |
| Topical antibiotic therapy | Experimental | Single antibiotic bladder irrigation. Receives: Combination Product: Antibiotic combination therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 days
Infection control
Higher body temperature (more than 37.5 degrees) recover to normal (between 36 - 37 degrees).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Less than or equal to 5 days
Secondary outcomes (1)
UTI recurrence expectation
Significant less UTI recurrence.
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2022
- Study start20 Jun 2023 (estimated)
- Primary completion31 Mar 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Urinary Tract InfectionsStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Esbjerg Hospital - University Hospital of Southern Denmark
- Responsible party
- Principal investigator, Zhijun Song, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05402319
- Sponsor's protocol ID
- Projekt-ID: S-20190083G CSF
- Status last verified
- May 2023
- First submitted
- 16 May 2022
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05402319
- Acronym / sponsor ID
- Projekt-ID: S-20190083G CSF
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- Esbjerg Hospital - University Hospital of Southern Denmark
- Study start
- 20 Jun 2023 (estimated)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 2 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 3
- 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).
| Arm | Type | Receives |
|---|---|---|
| Antibiotic monotherapy | Experimental | Combination Product: Antibiotic combination therapySingle antibiotic is given intravenously or orally (systemically). |
| Antibiotic combination therapy | Experimental | Combination Product: Antibiotic combination therapyAt least two different antibiotics are given intravenously or orally. |
| Topical antibiotic therapy | Experimental | Combination Product: Antibiotic combination therapySingle antibiotic bladder irrigation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients with nephrostomy catheters, J-J catheter, bricker bladder or urinary stones will be excluded from the project.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antibiotic combination therapyAlso: Systemic versus topical antibiotic therapiesAnti-infective treatment with at least two different types of sensitive antibiotics. | Combination product | Antibiotic combination therapy, Antibiotic monotherapy, Topical antibiotic therapy |
Primary outcome
Infection control
Time frame: 3 days
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
Time frame: Less than 3 days
Higher body temperature (more than 37.5 degrees) recover to normal (between 36 - 37 degrees).
Infection control
Time frame: Less than or equal to 5 days
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
Time frame: Less than or equal to 5 days
C-reactive protein (CRP) reduced from significantly higher than 10 mg/L to less than 10 mg/L.
Infection control
Time frame: Less than or equal to 5 days
Estimated glomerular filtration rate (eGFR) recovered from less than 60 mL/min/1,73 m2 to equal to 60 or higher.
1 secondary outcome
UTI recurrence expectation
Time frame: One month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
Related trials for Recurrent Urinary Tract Infections
Recruiting
Diagnosis and Treatment of Urinary Tract Infection Using DNA Polymerase Chain Reaction Versus Urine Culture
Urinary Tract Infections
Recruiting
INterest of the Negative Predictive Value of Integrons in the reduCtion of Large Broad-spectrum anTibiotics Consumption for Urinary Tract infectionS
Drug Resistance, Microbial, Biomarkers
Not yet recruitingObservational study
Comparative Study of the Genomic Characteristics of Uropathogenic Escherichia Coli According to the Severity of Community-Acquired Urinary Tract Infections in Guadeloupe (COLIGENURI)
Urinary Tract Infections
Active, not recruitingObservational study
Characterization of Vaginal, Urinary and Fecal Microbiomes in Women With Recurrent Urinary Tract Infections
Urinary Tract Infections, Menopause
RecruitingPhase 4
Prophylactic Antibiotics for Outpatient Urethral Bulking
Urinary Tract Infections, Stress Urinary Incontinence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Antibiotic combination therapy in people with Recurrent Urinary Tract Infections and Chronic Urinary-catheter-carrier, run by University of Southern Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhijun Song, M.D., Ph.D. (+45 41586848, Zhijun.Song@rsyd.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infection control (time frame: 3 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2023.