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NCT01289249 Clinical Trial

Meropenem Plasma Concentration Measurements at the Pediatric Medical Ward, Oslo University Hospital, Rikshospitalet

Bacterial Infection Clinical Trial

Official title:
Meropenem Plasma Concentration Measurements at the Pediatric Medical Ward, Oslo University Hospital, Rikshospitalet

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01289249
Other study ID # 2010/3023-1
Secondary ID
Status Completed
Phase N/A
First received January 31, 2011
Last updated November 5, 2014
Start date January 2011
Est. completion date January 2014

Study information
Verified date November 2014
Source Oslo University Hospital
Contact n/a
Is FDA regulated No
Health authority Norway:National Committee for Medical and Health Research Ethics
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 10
Est. completion date January 2014
Est. primary completion date January 2014
Accepts healthy volunteers No
Gender Both
Age group 3 Months to 18 Years
Eligibility Inclusion Criteria:

- Children aged from 3 months to 18 years that receive treatment with meropenem. Inclusion is independent of how long the patient has been receiving treatment. Children receiving other treatment (except hemodialysis)/other medications can be included.

Exclusion Criteria:

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Norway Oslo univeristy hospital, Rikshospitalet Oslo

Sponsors (1)
Lead Sponsor Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

References & 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. Epub 2007 Jun 6. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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) No
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