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

NCT ID: NCT01138566

Last Updated: 2010-06-07

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 400 participants
• Study Classification: OBSERVATIONAL

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.

Conditions

Urinary Tract Infections

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

Taipei Veterans General Hospital, Taiwan

OTHER_GOV

Sponsor Role: lead

Locations

Taipei Vterans General Hospital

Taipei, , Taiwan

Countries

Taiwan

Central Contacts

Chang-Phone Fung, M.D.

Role: CONTACT

cpfung@vghtpe.gov.tw

+886-2-2875-7494

Other Identifiers

IISP37925

Identifier Type: -

Identifier Source: org_study_id