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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01173068

Enrollment

Registered

2010-07-30

Start date

2010-08-31

Completion date

2014-09-30

Last updated

2014-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary Tract Infections

Keywords

Ertapenem, Clinical outcome, Complicated Urinary Tract Infections

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.

Interventions

DRUGErtapenem

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.

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

21 Years to 70 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

Singapore

Contacts

Primary ContactDale A Fisher

dale_andrew_fisher@nuhs.edu.sg(65) 6772 43 73

Backup ContactZuraidah Bt Sulaiman

Zuraidah_SULAIMAN@nuhs.edu.sg(65) 6772 2083

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026