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

Urinary Tract Infections Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01138566
• Other study ID #: IISP37925
• Status: Not yet recruiting
• Phase: N/A
• First received: June 4, 2010
• Last updated: June 4, 2010

Study information

• Verified date: April 2010
• Source: Taipei Veterans General Hospital, Taiwan
• Contact: Chang-Phone Fung, M.D.
• Phone: +886-2-2875-7494
• Email: cpfung[@]vghtpe.gov.tw
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 ß-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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Urinary Tract Infections

Locations

Country	Name	City	State
Taiwan	Taipei Vterans General Hospital	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
Taipei Veterans General Hospital, Taiwan	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

Taiwan,