An Observational Study of Ertapenem in Outpatient Parenteral Antibiotic Therapy (OPAT) for Complicated Urinary Tract Infections.
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|ClinicalTrials.gov Identifier: NCT01173068|
Recruitment Status : Unknown
Verified April 2014 by Medicine, National University Hospital, Singapore.
Recruitment status was: Recruiting
First Posted : July 30, 2010
Last Update Posted : April 3, 2014
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|
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 Type :||Observational|
|Estimated Enrollment :||60 participants|
|Observational Model:||Case Control|
|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|
- 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
- Clinical Outcome [ Time Frame: within 14 days of treatment and within 1 months after the treatment completion. ]
- 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
- Microbiology outcome [ Time Frame: 30 days after completion of treatment ]
urine culture results at the end of treatment and 30 days subsequent
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01173068
|Contact: Dale A Fisher||(65) 6772 43 email@example.com|
|Contact: Zuraidah Bt Sulaiman||(65) 6772 2083||Zuraidah_SULAIMAN@nuhs.edu.sg|
|National University Hospital||Recruiting|
|Singapore, Singapore, 119074|
|Sub-Investigator: Zuraidah Sulaiman|
|Principal Investigator:||Dale A Fisher||National University Hospital, Singapore|