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

• Conditions: Urinary Tract Infections

• Registration Number: NCT01173068
• Lead Sponsor: National University Hospital, Singapore

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.

Study Timeline

• Study First Submitted: 2010-07-28
• Study First Submitted QC: 2010-07-29
• Study First Posted: 2010-07-30
• Study Start: 2010-08
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-01
• Last Update Posted: 2014-04-03
• Primary Completion: 2014-09
• Study Completion: 2014-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical Outcome	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

Name	Time	Method
Microbiology outcome	30 days after completion of treatment	Measured by: urine culture results at the end of treatment and 30 days subsequent

Trial Locations

Locations (1)

National University Hospital; 🇸🇬 Singapore, Singapore