Urinary Tract InfectionsNCT01138566
Clinical Significance and Optimal Treatment of Community-onset Urinary Tract Infections Caused by Extended-spectrum β-lactamase and/or AmpC β-lactamase Producing Enterobacteriaceae
An observational study of Urinary Tract Infections, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Tract Infections
- How many people
- 400 participants
- Where
- 1 siteTaiwan
- Study dates
- Start not givento not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
The purposes of this study are:
- To estimate the prevalence of extended spectrum β-lactamase (ESBL) and/or AmpC among Enterobacteriaceae which cause community-onset urinary tract infections (UTIs)
- 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.
- 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
- 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.
Read more
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
- Keywords
- community-onset urinary tract infections caused by Enterobacteriaceae
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ESBL- and/or AmpC-(+) or (-) | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract InfectionsStudies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Collaborators
- Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01138566
- Sponsor's protocol ID
- IISP37925
- Status last verified
- Apr 2010
- First submitted
- 4 Jun 2010
- Last updated
- 7 Jun 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01138566
- Acronym / sponsor ID
- IISP37925
- Conditions
- Urinary Tract Infections
- Keywords
- community-onset urinary tract infections caused by Enterobacteriaceae
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Collaborators
- Merck Sharp & Dohme LLC
- First posted
- 7 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purposes of this study are:
- To estimate the prevalence of extended spectrum β-lactamase (ESBL) and/or AmpC among Enterobacteriaceae which cause community-onset urinary tract infections (UTIs)
- 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.
- 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
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ESBL- and/or AmpC-(+) or (-) | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (8 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Tract Infections, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chang-Phone Fung, M.D. (+886-2-2875-7494, cpfung@vghtpe.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2010.