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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01289249
First received: January 31, 2011
Last updated: February 22, 2012
Last verified: February 2012
History of Changes
  Purpose

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.


Condition
Bacterial Infection

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Meropenem Plasma Concentration Measurements at the Pediatric Medical Ward, Oslo University Hospital, Rikshospitalet

Resource links provided by NLM:

Drug Information available for: Meropenem
U.S. FDA Resources

Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples Without DNA

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


Estimated Enrollment: 50
Study Start Date: January 2011
Estimated Study Completion Date: December 2015
Groups/Cohorts
Children receiving meropenem
Children aged from 3 months to 18 years that receive treatment with meropenem.

  Eligibility

Ages Eligible for Study:   3 Months to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients at the Pediatric medical ward.

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01289249

Locations
Norway
Oslo univeristy hospital, Rikshospitalet
Oslo, Norway, 0424
Sponsors and Collaborators
Oslo University Hospital
Investigators
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
  More Information

Publications:

Responsible Party: Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01289249     History of Changes
Other Study ID Numbers: 2010/3023-1
Study First Received: January 31, 2011
Last Updated: February 22, 2012
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Oslo University Hospital:
meropenem
child
bacterial infection
treatment evaluation

Additional relevant MeSH terms:
Bacterial Infections
Meropenem
Anti-Bacterial Agents
 Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 30, 2012