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 | Unknown DMC

• 1 other identifier: IISP37925
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

The purposes of this study are:

1. 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. 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. 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. 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.

Conditions

Urinary Tract Infections

Keywords

community-onset urinary tract infections caused by Enterobacteriaceae

Study Arms (1)

ESBL- and/or AmpC-(+) or (-)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients who admitted to the Taipei Veterans General Hospital, a 2900-bed tertiary-care teaching hospital located in Taipei, Taiwan, with the diagnosis of community-onset UTI caused by Enterobacteriaceae

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Taipei Vterans General Hospital

Taipei, 11217, Taiwan

Location

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

Chang-Phone Fung, M.D.

CONTACT

+886-2-2875-7494; cpfung@vghtpe.gov.tw

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: June 4, 2010
• First Posted: June 7, 2010
• Last Updated: June 7, 2010

Record last verified: 2010-04

Locations

TW (1)