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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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by Taipei Veterans General Hospital,Taiwan.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Merck
Information provided by:
Taipei Veterans General Hospital,Taiwan
ClinicalTrials.gov Identifier:
NCT01138566
First received: June 4, 2010
Last updated: NA
Last verified: April 2010
History: No changes posted
  Purpose

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.


Condition
Urinary Tract Infections

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Taipei Veterans General Hospital,Taiwan:

Estimated Enrollment: 400
Groups/Cohorts
ESBL- and/or AmpC-(+) or (-)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01138566

Contacts
Contact: Chang-Phone Fung, M.D. +886-2-2875-7494 cpfung@vghtpe.gov.tw

Locations
Taiwan
Taipei Vterans General Hospital Not yet recruiting
Taipei, Taiwan, 11217
Sponsors and Collaborators
Taipei Veterans General Hospital,Taiwan
Merck
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01138566     History of Changes
Other Study ID Numbers: IISP37925
Study First Received: June 4, 2010
Last Updated: June 4, 2010
Health Authority: Taiwan: Department of Health

Keywords provided by Taipei Veterans General Hospital,Taiwan:
community-onset urinary tract infections caused by Enterobacteriaceae

Additional relevant MeSH terms:
Urinary Tract Infections
Infection
Urologic Diseases

ClinicalTrials.gov processed this record on May 19, 2013