An Observational Study of Ertapenem in Outpatient Parenteral Antibiotic Therapy (OPAT) for Complicated Urinary Tract Infections.
Information source: National University Hospital, Singapore
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Urinary Tract Infections
Intervention: Ertapenem (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: National University Hospital, Singapore Official(s) and/or principal investigator(s):
Dale A Fisher, Principal Investigator, Affiliation: National University Hospital, Singapore
Overall contact:
Dale A Fisher, Phone: (65) 6772 43 73, Email: dale_andrew_fisher@nuhs.edu.sg
Summary
The aim of this study is to determine the outcomes when using ertapenem for complicated
urinary tract infections in the OPAt setting.
The study hypothesis: Ertapenem is an efficacious and safe therapeutic option for
complicated urinary tract infections in the OPAt setting.
Clinical Details
Official title: A Prospective Observational Study of Ertapenem in Outpatient Parenteral Antibiotic Therapy (OPAT) for Complicated Urinary Tract Infections.
Study design: Observational Model: Case Control, Time Perspective: Prospective
Primary outcome: Clinical Outcome
Secondary outcome: Microbiology outcome
Detailed description:
Enterobactericae spp. is a common cause of urinary tract infections. The prevalence of
quinolone-resistance in Enterobactericae is rising and often co-exists with expression of
extended-spectrum beta-lactamases (ESBL, limiting viable outpatient therapeutics options.
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.
Eligibility
Minimum age: 21 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Adult patients between 21 years old to 70 years old.
- 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:
- Hypersensitivity reactions to Ertapenem.
- Participation in another interventional clinical investigation within 30days
- Unable to obtain informed consent.
Locations and Contacts
Dale A Fisher, Phone: (65) 6772 43 73, Email: dale_andrew_fisher@nuhs.edu.sg
National University Hospital, Singapore 119074, Singapore; Recruiting
Zuraidah Sulaiman, Sub-Investigator
Additional Information
Related publications: 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, D.A., Kurup, A., Lye, D., Tambyah, P.A., Sulaiman, Z., Poon, E.Y.H., Lee, W., Kaur, V., Lim, P.L.(2006). 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. Epub 2007 Jul 13.
Starting date: August 2010
Last updated: April 1, 2014
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