Ignite Creation Date:
2024-05-05 @ 10:34 PM
Last Modification Date:
2024-10-26 @ 10:20 AM
Study NCT ID:
NCT01138566
Status:
UNKNOWN
Last Update Posted:
2010-06-07
First Post:
2010-06-04
Brief Title:
Clinical Significance and Optimal Treatment of Community-onset Urinary Tract Infections Caused by Extended-spectrum β-lactamase andor AmpC β-lactamase Producing Enterobacteriaceae
Sponsor:
Taipei Veterans General Hospital Taiwan
Organization:
Taipei Veterans General Hospital Taiwan
Study Overview
Official Title:
Clinical Significance and Optimal Treatment of Community-onset Urinary Tract Infections Caused by Extended-spectrum β-lactamase andor AmpC β-lactamase Producing Enterobacteriaceae
Status:
UNKNOWN
Status Verified Date:
2010-04
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:
None
Brief Summary:
The purposes of this study are
1 To estimate the prevalence of extended spectrum β-lactamase ESBL andor AmpC among Enterobacteriaceae which cause community-onset urinary tract infections UTIs
2 To collect the background risk factors and clinical outcome of patients with community-acquired uropathogenic condition related to Enterobacteriaceae both ESBL AmpC- and non ESBL andor AmpC producing after receive different antibiotic regimens
3 To develop a scoring system to early identify patients at risk of being infected with ESBL- andor AmpC-producing Enterobacteriaceae by comparing the risk factors for community-onset UTIs caused by ESBL- andor AmpC-positive against non ESBL -andor AmpC Enterobacteriaceae
4 To demonstrate the efficacy and safety of ertapenem for the empiric treatment of community-onset UTIs in patients at risk for ESBL- andor AmpC-producing organism
The study hypothesis i Patients infected with community-acquired uropathogenic ESBL- andor AmpC-producing Enterobacteriaceae who receive regimens other than carbapenems have a worse outcome
ii There are certain risk factors predicting the acquisition of community-onset UTIs caused by ESBL- andor AmpC-producing Enterobacteriaceae
iii The use of ertapenem is an effective and safe empirical therapy compared with other agents for community-onset UTIs caused by ESBL- andor AmpC-producing Enterobacteriaceae
1 To estimate the prevalence of extended spectrum β-lactamase ESBL andor AmpC among Enterobacteriaceae which cause community-onset urinary tract infections UTIs
2 To collect the background risk factors and clinical outcome of patients with community-acquired uropathogenic condition related to Enterobacteriaceae both ESBL AmpC- and non ESBL andor AmpC producing after receive different antibiotic regimens
3 To develop a scoring system to early identify patients at risk of being infected with ESBL- andor AmpC-producing Enterobacteriaceae by comparing the risk factors for community-onset UTIs caused by ESBL- andor AmpC-positive against non ESBL -andor AmpC Enterobacteriaceae
4 To demonstrate the efficacy and safety of ertapenem for the empiric treatment of community-onset UTIs in patients at risk for ESBL- andor AmpC-producing organism
The study hypothesis i Patients infected with community-acquired uropathogenic ESBL- andor AmpC-producing Enterobacteriaceae who receive regimens other than carbapenems have a worse outcome
ii There are certain risk factors predicting the acquisition of community-onset UTIs caused by ESBL- andor AmpC-producing Enterobacteriaceae
iii The use of ertapenem is an effective and safe empirical therapy compared with other agents for community-onset UTIs caused by ESBL- andor AmpC-producing Enterobacteriaceae
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