An Observational Study of Ertapenem in Outpatient Parenteral Antibiotic Therapy (OPAT) for Complicated Urinary Tract Infections.
NCT ID: NCT01173068
Last Updated: 2014-04-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
60 participants
OBSERVATIONAL
2010-08-31
2014-09-30
Brief Summary
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The study hypothesis: Ertapenem is an efficacious and safe therapeutic option for complicated urinary tract infections in the OPAt setting.
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Detailed Description
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In Singapore, there is an increasing trend of treating patients who respond favourably to initial antimicrobial therapy in the outpatient setting (Fisher, et.al, 2006). Ertapenem is one of several agents with excellent antimicrobial activity against Enterobactericae (including ESBL producers). In view of its safety profile and its viability in elastromeric pump, it has great potential to be used in OPAT patients.
There is no study analyzing outcomes in a large cohort of patients with complicated urinary tract infections treated with ertapenem.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Interventions
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Ertapenem
Prescribed IV Ertapenem 1gm (or renally adjusted dose) will be administered every 24 hours. The duration of treatment will be determined by the clinician and this typically is 2 weeks, or as clinically indicated.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosed with complicated urinary tract infection due to pathogen susceptible to ertapenem based on microbiology report, and the use of ertapenem is deemed clinically appropriate by the Infectious Disease physician in charge.
Exclusion Criteria
* Participation in another interventional clinical investigation within 30days
* Unable to obtain informed consent.
21 Years
70 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
National University Hospital, Singapore
OTHER
Responsible Party
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Medicine
A/Prof Dale Fisher
Principal Investigators
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Dale A Fisher
Role: PRINCIPAL_INVESTIGATOR
National University Hospital, Singapore
Locations
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National University Hospital
Singapore, Singapore, Singapore
Countries
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Central Contacts
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References
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Brink AJ, Richards GA, Schillack V, Kiem S, Schentag J. Pharmacokinetics of once-daily dosing of ertapenem in critically ill patients with severe sepsis. Int J Antimicrob Agents. 2009 May;33(5):432-6. doi: 10.1016/j.ijantimicag.2008.10.005. Epub 2008 Dec 16.
Fisher DA, Kurup A, Lye D, Tambyah PA, Sulaiman Z, Poon EY, Lee W, Kaur V, Lim PL. Outpatient parenteral antibiotic therapy in Singapore. Int J Antimicrob Agents. 2006 Dec;28(6):545-50. doi: 10.1016/j.ijantimicag.2006.08.018. Epub 2006 Nov 13.
Teng CP, Chen HH, Chan J, Lye DC. Ertapenem for the treatment of extended-spectrum beta-lactamase-producing Gram-negative bacterial infections. Int J Antimicrob Agents. 2007 Oct;30(4):356-9. doi: 10.1016/j.ijantimicag.2007.05.016. Epub 2007 Jul 13.
Other Identifiers
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DSRB Domain E/10/312
Identifier Type: -
Identifier Source: org_study_id
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