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Clinical Significance and Optimal Treatment of Community-onset Urinary Tract Infections Caused by Extended-spectrum β-lactamase and/or AmpC β-lactamase Producing Enterobacteriaceae

NCT01138566 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 400

Last updated 2010-06-07

No results posted yet for this study

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.

Conditions

Sponsors & Collaborators

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • Taiwan

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01138566 on ClinicalTrials.gov