NCT01289249

Brief Summary

The object of the study is to investigate whether all included patients receive treatment that is effective against all bacteria that are defined as sensitive to meropenem with the current treatment regimen. Will the investigators findings motivate routine monitoring of plasma concentrations in children receiving meropenem? Up to 50 patients will be included in the study, and all participants are children.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2011

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 31, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 3, 2011

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

November 6, 2014

Status Verified

November 1, 2014

Enrollment Period

3 years

First QC Date

January 31, 2011

Last Update Submit

November 5, 2014

Conditions

Bacterial Infection

Keywords

meropenemchildbacterial infectiontreatment evaluation

Outcome Measures

Primary Outcomes (1)

  • We will determine how many of the patients in our material that have plasma concentrations of meropenem above 8 mg/l for at least 40% and 75% of the time.

    1 dosing interval (8 hours)

Study Arms (1)

Children receiving meropenem

Children aged from 3 months to 18 years that receive treatment with meropenem.

Eligibility Criteria

Age3 Months - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients at the Pediatric medical ward.

You may not qualify if:

  • Children less than three months of age. Patients receiving hemodialysis. Lack of consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo univeristy hospital, Rikshospitalet

Oslo, 0424, Norway

Location

Related Publications (1)

  • Ikeda K, Ikawa K, Morikawa N, Miki M, Nishimura S, Kobayashi M. High-performance liquid chromatography with ultraviolet detection for real-time therapeutic drug monitoring of meropenem in plasma. J Chromatogr B Analyt Technol Biomed Life Sci. 2007 Sep 1;856(1-2):371-5. doi: 10.1016/j.jchromb.2007.05.043. Epub 2007 Jun 6.

    PMID: 17581801BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Two blood samples are taken from each included patient. (Each 2 ml heparin full blood).

MeSH Terms

Conditions

Bacterial Infections

Condition Hierarchy (Ancestors)

Bacterial Infections and MycosesInfections

Study Officials

  • Odd Brørs, Dr Med

    Oslo University Hospital

    STUDY DIRECTOR

  • Margrete L Burns, BMed

    Oslo univeristy hospital

    STUDY CHAIR

  • Øystein Riise, PhD

    Oslo University Hospital

    STUDY CHAIR

  • Tore Abrahamsen, Dr Med

    Oslo univeristy hospital

    STUDY CHAIR

  • Gaut Gadeholt, Dr Med

    Oslo University Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2011

First Posted

February 3, 2011

Study Start

January 1, 2011

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

November 6, 2014

Record last verified: 2014-11

Locations

NO(1)