Clinical Significance and Optimal Treatment of Community-onset Urinary Tract Infections Caused by Extended-spectrum β-lactamase and/or AmpC β-lactamase Producing Enterobacteriaceae
|ClinicalTrials.gov Identifier: NCT01138566|
Recruitment Status : Unknown
Verified April 2010 by Taipei Veterans General Hospital, Taiwan.
Recruitment status was: Not yet recruiting
First Posted : June 7, 2010
Last Update Posted : June 7, 2010
The purposes of this study are:
- To estimate the prevalence of extended spectrum β-lactamase (ESBL) and/or AmpC among Enterobacteriaceae which cause community-onset urinary tract infections (UTIs)
- 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 and/or AmpC producing) after receive different antibiotic regimens.
- To develop a scoring system to early identify patients at risk of being infected with ESBL- and/or AmpC-producing Enterobacteriaceae by comparing the risk factors for community-onset UTIs caused by ESBL- and/or AmpC-positive against non ESBL -and/or AmpC Enterobacteriaceae
- To demonstrate the efficacy and safety of ertapenem for the empiric treatment of community-onset UTIs in patients at risk for ESBL- and/or AmpC-producing organism.
The study hypothesis (i) Patients infected with community-acquired uropathogenic ESBL- and/or 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- and/or 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- and/or AmpC-producing Enterobacteriaceae.
|Condition or disease|
|Urinary Tract Infections|
|Study Type :||Observational|
|Estimated Enrollment :||400 participants|
|Official Title:||Clinical Significance and Optimal Treatment of Community-onset Urinary Tract Infections Caused by Extended-spectrum β-lactamase and/or AmpC β-lactamase Producing Enterobacteriaceae|
|ESBL- and/or AmpC-(+) or (-)|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01138566
|Contact: Chang-Phone Fung, M.D.||+firstname.lastname@example.org|
|Taipei Vterans General Hospital||Not yet recruiting|
|Taipei, Taiwan, 11217|