An Observational Study of Ertapenem in Outpatient Parenteral Antibiotic Therapy (OPAT) for Complicated Urinary Tract Infections.
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.
|Study Design:||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.|
- Clinical Outcome [ Time Frame: within 14 days of treatment and within 1 months after the treatment completion. ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
urine culture results at the end of treatment and 30 days subsequent
|Study Start Date:||August 2010|
|Estimated Study Completion Date:||September 2014|
|Estimated Primary Completion Date:||September 2014 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01173068
|Contact: Dale A Fisher||(65) 6772 43 firstname.lastname@example.org|
|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|