Ignite Creation Date:
2024-05-06 @ 5:43 PM
Last Modification Date:
2024-10-26 @ 2:34 PM
Study NCT ID:
NCT05402319
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-05-10
First Post:
2022-05-16
Brief Title:
Comparison of Three Different Antibiotic Treatments Against Recurrent Urinary Tract Infections in Catheterized Patients
Sponsor:
University of Southern Denmark
Organization:
University of Southern Denmark
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 iv and po 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 httpspromedicindk 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
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 httpspromedicindk 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None