Ignite Creation Date:
2024-05-06 @ 6:03 PM
Last Modification Date:
2024-10-26 @ 2:41 PM
Study NCT ID:
NCT05534399
Status:
UNKNOWN
Last Update Posted:
2022-09-09
First Post:
2022-06-07
Brief Title:
Antibiotic Strategy and Asymptomatic Bacteriuria in the Context of Intra-vesical Botulinum Toxin A Injections
Sponsor:
University Hospital Lille
Organization:
University Hospital Lille
Study Overview
Official Title:
Assessment of the Interest of a Peri-operative Antibiotic Strategy Applied to Patients With Asymptomatic Bacteriuria Undergoing Intra-vesical Botulinum Toxin A Injections
Status:
UNKNOWN
Status Verified Date:
2022-06
Last Known Status:
NOT_YET_RECRUITING
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:
ANTIBIOBONTA
Brief Summary:
The study aims to demonstrate that the thrifty antibiotic strategy applied to MS or SCI patients with asymptomatic bacteriuria prior to BoNTA intravesical injections does not increase the rate of symptomatic post-injection UTIs compared to the current peri-operative antibiotic strategy
Patients included in the study will be randomized in two balanced-parallel groups 4 days - 2 days before intra-vesical BoNTA injections
Group 1 Experimental group Sparing antibiotic strategy No antibiotic therapy will be administered during the peri-operative period
Group 2 Control group Recommendations - Peri-operative antibiotic strategy An antibiotic therapy will be administered during the peri-operative period The antibiotic will be selected according to the type of bacteria isolated and the antibiotic susceptibility testing and started two days before and pursued until two days following intra-vesical BoNTA injections
The main objective is to demonstrate the non-inferiority of antibiotic saving strategy compared to peri-operative antibiotic strategy current recommendations for occurrence of symptomatic UTI after intra-vesical BoNTA injections in the management of asymptomatic bacteriuria AB among multiple sclerosis MS and spinal cord injured SCI patients undergoing clean intermittent self-catheterization CISC
Patients included in the study will be randomized in two balanced-parallel groups 4 days - 2 days before intra-vesical BoNTA injections
Group 1 Experimental group Sparing antibiotic strategy No antibiotic therapy will be administered during the peri-operative period
Group 2 Control group Recommendations - Peri-operative antibiotic strategy An antibiotic therapy will be administered during the peri-operative period The antibiotic will be selected according to the type of bacteria isolated and the antibiotic susceptibility testing and started two days before and pursued until two days following intra-vesical BoNTA injections
The main objective is to demonstrate the non-inferiority of antibiotic saving strategy compared to peri-operative antibiotic strategy current recommendations for occurrence of symptomatic UTI after intra-vesical BoNTA injections in the management of asymptomatic bacteriuria AB among multiple sclerosis MS and spinal cord injured SCI patients undergoing clean intermittent self-catheterization CISC
Detailed Description:
None
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| PHRC-19-0218 | OTHER | DGOS number PHRC-N | None |
| 2020-A03361-38 | OTHER | None | None |