NCT01173068

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 28, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 30, 2010

Completed
2 days until next milestone

Study Start

First participant enrolled

August 1, 2010

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

April 3, 2014

Status Verified

April 1, 2014

Enrollment Period

4.1 years

First QC Date

July 28, 2010

Last Update Submit

April 1, 2014

Conditions

Urinary Tract Infections

Keywords

ErtapenemClinical outcomeComplicated Urinary Tract Infections

Outcome Measures

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

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

Secondary Outcomes (1)

  • Microbiology outcome

    30 days after completion of treatment

Interventions

ErtapenemDRUG

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

Eligibility Criteria

Age21 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National University Hospital

Singapore, Singapore, 119074, Singapore

RECRUITING

Related Publications (3)

  • 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.

    PMID: 19091521BACKGROUND

  • 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.

    PMID: 17097856BACKGROUND

  • 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.

    PMID: 17631986BACKGROUND

MeSH Terms

Conditions

Urinary Tract Infections

Interventions

Ertapenem

Condition Hierarchy (Ancestors)

InfectionsUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Carbapenemsbeta-LactamsLactamsAmidesOrganic ChemicalsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Dale A Fisher

    National University Hospital, Singapore

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dale A Fisher

CONTACT

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

Zuraidah Bt Sulaiman

CONTACT

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

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
A/Prof Dale Fisher

Study Record Dates

First Submitted

July 28, 2010

First Posted

July 30, 2010

Study Start

August 1, 2010

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

April 3, 2014

Record last verified: 2014-04

Locations

SG(1)