An Observational Study of Ertapenem in Outpatient Parenteral Antibiotic Therapy (OPAT) for Complicated Urinary Tract Infections.

Study Description

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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.

Condition or disease	Intervention/treatment
Urinary Tract Infections	Drug: Ertapenem

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.

Study Design

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Study Type :	Observational
Estimated Enrollment :	60 participants
Observational Model:	Case Control
Time Perspective:	Prospective
Official Title:	A Prospective Observational Study of Ertapenem in Outpatient Parenteral Antibiotic Therapy (OPAT) for Complicated Urinary Tract Infections.
Study Start Date :	August 2010
Estimated Primary Completion Date :	September 2014
Estimated Study Completion Date :	September 2014

Groups and Cohorts

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Intervention Details:

Drug: 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 Name: Invanz

Outcome Measures

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Primary Outcome Measures :

1. Clinical Outcome [ Time Frame: within 14 days of treatment and within 1 months after the treatment completion. ]

   Measured by:

   1. Clinical features within 14 days of treatmnet:(improving/resolving/deteriorating) during therapy in OPAT eg dysuria,suprapubic pain, frequency, fever, urinalysis.
   2. Clinical features of recurrences with 1 month after therapy completion
   3. Presence of hospitalization and/or
   4. Mortality

Secondary Outcome Measures :

1. Microbiology outcome [ Time Frame: 30 days after completion of treatment ]

   Measured by:

   urine culture results at the end of treatment and 30 days subsequent

Eligibility Criteria

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Ages Eligible for Study:	21 Years to 70 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
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.

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.

Contacts and Locations

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Dale A Fisher	(65) 6772 43 73	dale_andrew_fisher@nuhs.edu.sg
Contact: Zuraidah Bt Sulaiman	(65) 6772 2083	Zuraidah_SULAIMAN@nuhs.edu.sg

Locations

Singapore
National University Hospital	Recruiting
Singapore, Singapore, 119074
Sub-Investigator: Zuraidah Sulaiman

Sponsors and Collaborators

National University Hospital, Singapore

Merck Sharp & Dohme Corp.

Investigators

Principal Investigator:	Dale A Fisher	National University Hospital, Singapore

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Responsible Party:	Medicine, A/Prof Dale Fisher, National University Hospital, Singapore
ClinicalTrials.gov Identifier:	NCT01173068 History of Changes
Other Study ID Numbers:	DSRB Domain E/10/312
First Posted:	July 30, 2010
Last Update Posted:	April 3, 2014
Last Verified:	April 2014

Keywords provided by Medicine, National University Hospital, Singapore:

Ertapenem; Clinical outcome; Complicated Urinary Tract Infections

Additional relevant MeSH terms:

Infection; Communicable Diseases; Urinary Tract Infections; Urologic Diseases	Anti-Bacterial Agents; Ertapenem; Anti-Infective Agents