Urinary Tract Infections
Conditions
Keywords
community-onset urinary tract infections caused by Enterobacteriaceae
Brief summary
The purposes of this study are: 1. To estimate the prevalence of extended spectrum β-lactamase (ESBL) and/or 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 and/or AmpC producing) after receive different antibiotic regimens. 3. 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 4. 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.
Interventions
None listed
Sponsors
Merck Sharp & Dohme LLC
Taipei Veterans General Hospital, Taiwan
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients who admitted to the Taipei Veterans General Hospital with the diagnosis of community-onset UTI caused by Enterobacteriaceae will be eligible for inclusion in this study if hospitalization for parental antimicrobial therapy is required
Exclusion criteria
* pregnancy or lactation in women, * history of serious allergy or intolerance to study drug therapy (patients with a history of mild rash to β-lactams could be enrolled), * complete obstruction of the urinary tract, * peri-nephritic or intrarenal abscess, prostatitis, any rapidly progressive disease or terminal illness, * immuno-compromising illness or immuno suppression therapy, the need for concomitant antimicrobials in addition to study therapy, * a baseline pathogen resistant to study drug, * treatment with a systemic antimicrobial agent for \>24 h within 72 h prior to enrolment, or absolute neutrophil count \<1000/mm3. * Men with a history or physical findings suggestive of acute or chronic prostatitis will also excluded.
Countries
Taiwan
Contacts
Primary ContactChang-Phone Fung, M.D.
Outcome results
None listed