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

Urinary Tract Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01173068
• Other study ID #: DSRB Domain E/10/312
• Status: Recruiting
• Phase: N/A
• First received: July 28, 2010
• Last updated: April 1, 2014
• Start date: August 2010
• Est. completion date: September 2014

Study information

• Verified date: April 2014
• Source: National University Hospital, Singapore
• Contact: Dale A Fisher
• Phone: (65) 6772 43 73
• Email: dale_andrew_fisher[@]nuhs.edu.sg
• Is FDA regulated: No
• Health authority: Singapore: Domain Specific Review Boards
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 70 Years

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Urinary Tract Infections

Intervention

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.

Locations

Country	Name	City	State
Singapore	National University Hospital	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
National University Hospital, Singapore	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

Singapore, 

References & Publications (3)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Outcome	Measured by: Clinical features within 14 days of treatmnet:(improving/resolving/deteriorating) during therapy in OPAT eg dysuria,suprapubic pain, frequency, fever, urinalysis.; Clinical features of recurrences with 1 month after therapy completion; Presence of hospitalization and/or; Mortality	within 14 days of treatment and within 1 months after the treatment completion.	No
Secondary	Microbiology outcome	Measured by: urine culture results at the end of treatment and 30 days subsequent	30 days after completion of treatment	No