Clinical trial NCT01173068: An Observational Study of Ertapenem in Outpatient Parenteral Antibiotic Therapy (OPAT) for Complicated Urinary Tract Infections.
Official title: A Prospective Observational Study of Ertapenem in Outpatient Parenteral Antibiotic Therapy (OPAT) for Complicated Urinary Tract Infections.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Urinary Tract Infections
Keywords: Ertapenem
Clinical outcome
Complicated Urinary Tract Infections
Lead sponsor: National University Hospital, Singapore
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2010-07-30
Enrollment: 60
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults OPAT patients diagnosed with complicated urinary tract infections and whom require IV Ertapenem will be enrolled over a period of 1-2 years.

Brief 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.

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 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.

Primary outcomes:
measure: Clinical Outcome
timeFrame: within 14 days of treatment and within 1 months after the treatment completion.
Secondary outcomes:
measure: Microbiology outcome
timeFrame: 30 days after completion of treatment
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University Hospital
Study officials:
affiliation: National University Hospital, Singapore
name: Dale A Fisher
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.