Ignite Creation Date:
2024-05-05 @ 8:03 PM
Last Modification Date:
2024-10-26 @ 9:58 AM
Study NCT ID:
NCT00795470
Status:
WITHDRAWN
Last Update Posted:
2015-12-03
First Post:
2008-11-20
Brief Title:
Factorial Trial of Antimicrobial Therapy andor Catheter Change for Catheter Urinary Tract Infections
Sponsor:
Unity Health Toronto
Organization:
Unity Health Toronto
Study Overview
Official Title:
A Pilot Concealed Randomized Double-blinded Placebo-controlled Factorial Trial of Antimicrobial Therapy andor Catheter Change for Catheter-associated Urinary Tract Infections in the Critically Ill
Status:
WITHDRAWN
Status Verified Date:
2015-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not pursuing the study due to funding issues
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CAUTION
Brief Summary:
Urinary tract infection UTI is a common infection in patients in the intensive care unit ICU that increases length of stay but not mortality It is not known whether antibiotic treatment will alter outcomes Our previous studies have documented wide practice variations exist amongst doctors including prescribing antibiotics to asymptomatic patients Therefore the merits of various ways to manage the infection require further studies to minimize the potential for over-prescribing of antibiotics a practice that can increase the development of resistant bacteria
The objective of this pilot study is to determine the feasibility of conducting a larger definitive study that will determine the effect of catheter change andor systemic antibiotics as compared to no interventions on outcomes and resource utilization in ICU patients with UTI Patients will be randomized to receive no treatment antibiotics alone urine catheter change alone and both catheter change and antibiotics Their clinical outcomes will be assessed
Results from the pilot trial will provide information about whether it is feasible to conduct the larger definitive trial Results of the definitive study will provide guidance to clinicians on how to manage a frequent clinical problem and optimize antibiotic usage
The objective of this pilot study is to determine the feasibility of conducting a larger definitive study that will determine the effect of catheter change andor systemic antibiotics as compared to no interventions on outcomes and resource utilization in ICU patients with UTI Patients will be randomized to receive no treatment antibiotics alone urine catheter change alone and both catheter change and antibiotics Their clinical outcomes will be assessed
Results from the pilot trial will provide information about whether it is feasible to conduct the larger definitive trial Results of the definitive study will provide guidance to clinicians on how to manage a frequent clinical problem and optimize antibiotic usage
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None