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Status unknownNCT01173068Updated Apr 3, 2014

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

An observational study in Urinary Tract Infections, sponsored by National University Hospital, Singapore. Status unknown at 1 site in Singapore. Open to participants aged 21 Years to 70 Years. Per ClinicalTrials.gov, last updated 2014-04-03.

Sponsored by National University Hospital, Singapore · Observational

The sponsor has not verified this record recently (last verified Apr 2014), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
60
Ages
21 Years to 70 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Urinary Tract Infections

Keywords

  • Ertapenem
  • Clinical outcome
  • Complicated Urinary Tract Infections
03

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's planned enrollment of 60 is below the median of 240 across 2,136 observational studies indexed under Infections.

Browse Infections studies →

Lead sponsor

National University Hospital, Singapore is the lead sponsor of 444 studies on the registry; 96 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adults OPAT patients diagnosed with complicated urinary tract infections and whom require IV Ertapenem will be enrolled over a period of 1-2 years.

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

Exclusion Criteria:

  • Hypersensitivity reactions to Ertapenem.
  • Participation in another interventional clinical investigation within 30days
  • Unable to obtain informed consent.
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
60 participants (estimated)

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.

    Also known as: Invanz

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What researchers measure

Primary outcomes

  1. Clinical Outcome

    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

    Time frame: within 14 days of treatment and within 1 months after the treatment completion.

Secondary outcomes

  1. Microbiology outcome

    Measured by: urine culture results at the end of treatment and 30 days subsequent

    Time frame: 30 days after completion of treatment

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Study locations

1 of 1 sites recruiting
  • National University Hospital
    Singapore, 119074, Singapore
    • Zuraidah Sulaiman · Sub investigator
    Recruiting
08

References and documents

Publications

  • 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. PubMed 19091521 ↗
  • Fisher DA, Kurup A, Lye D, Tambyah PA, Sulaiman Z, Poon EY, Lee W, Kaur V, Lim PL. Outpatient parenteral antibiotic therapy in Singapore. Int J Antimicrob Agents. 2006 Dec;28(6):545-50. doi: 10.1016/j.ijantimicag.2006.08.018. Epub 2006 Nov 13. PubMed 17097856 ↗
  • 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. doi: 10.1016/j.ijantimicag.2007.05.016. Epub 2007 Jul 13. PubMed 17631986 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 3, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01173068
Lead sponsor
National University Hospital, Singapore
Collaborators
Merck Sharp & Dohme LLC
Responsible party
Medicine (A/Prof Dale Fisher, National University Hospital, Singapore) — Principal investigator
First posted
Jul 30, 2010
Start date
Aug 2010
Primary completion
Sep 2014 (estimated)
Completion
Sep 2014 (estimated)
Last update
Apr 3, 2014

Study contacts

Dale A Fisher
Contact
dale_andrew_fisher@nuhs.edu.sg
(65) 6772 43 73
Zuraidah Bt Sulaiman
Contact
Zuraidah_SULAIMAN@nuhs.edu.sg
(65) 6772 2083
Dale A Fisher
principal investigator · National University Hospital, Singapore

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2014. You cannot join it, but the record below documents what was studied.

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