Ignite Creation Date:
2024-05-05 @ 11:39 PM
Last Modification Date:
2024-10-26 @ 10:37 AM
Study NCT ID:
NCT01388413
Status:
COMPLETED
Last Update Posted:
2017-02-24
First Post:
2011-06-23
Brief Title:
Safety and Efficacy of a Weekly Oral Cyclic Antibiotic Programme in the Prevention of Urinary Tract Infection on Neurological Bladder
Sponsor:
University Hospital Tours
Organization:
University Hospital Tours
Study Overview
Official Title:
A Randomized Multicenter Parallel Group Study to Evaluate Safety and Efficacy of a Weekly Oral Cyclic Antibiotic Programme in the Prevention of Urinary Tract Infection on Neurological Bladder
Status:
COMPLETED
Status Verified Date:
2017-02
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:
PACHIU
Brief Summary:
Symptomatic urinary tract infections UTIs are one of the main causes of morbidity and the main cause of re-hospitalization in subjects with neurogenic bladder Long-term antibiotic therapy increases the risk of multi-resistant bacterial infections without reducing the rate of symptomatic UTIs Our non-comparative preliminary study has shown that Weekly Oral Cyclic Antibiotic Programme single weekly dose of antibiotic X on even weeks and antibiotic Y on odd weeks seem to drastically reduce both the number of symptomatic UTIs and the number of hospitalizations in patients with neurogenic bladder without affecting bacterial ecology
The objective of this study is to validate this preliminary work with a large-scale randomized parallel-group multicenter study
The objective of this study is to validate this preliminary work with a large-scale randomized parallel-group multicenter study
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 |
|---|---|---|---|
| 2010-021241-44 | EUDRACT_NUMBER | None | None |
| A101183-72 | OTHER | None | None |
| 2010-R31 | OTHER | CPP | None |