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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01289249
First received: January 31, 2011
Last updated: November 5, 2014
Last verified: November 2014

January 31, 2011
November 5, 2014
January 2011
January 2014   (final data collection date for primary outcome measure)
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. [ Time Frame: 1 dosing interval (8 hours) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01289249 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Meropenem Plasma Concentration Measurements at the Pediatric Medical Ward, Oslo University Hospital, Rikshospitalet
Meropenem Plasma Concentration Measurements at the Pediatric Medical Ward, Oslo University Hospital, Rikshospitalet

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

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

Non-Probability Sample

Patients at the Pediatric medical ward.

Bacterial Infection
Not Provided
Children receiving meropenem
Children aged from 3 months to 18 years that receive treatment with meropenem.
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
January 2014
January 2014   (final data collection date for primary outcome measure)

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.
Both
3 Months to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT01289249
2010/3023-1
No
Oslo University Hospital
Oslo University Hospital
Not Provided
Study Director: Odd Brørs, Dr Med Oslo University Hospital
Study Chair: 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
Oslo University Hospital
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP