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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01289249
First Posted: February 3, 2011
Last Update Posted: November 6, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Oslo University Hospital
  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:


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) ]

Biospecimen Retention:   Samples Without DNA
Two blood samples are taken from each included patient. (Each 2 ml heparin full blood).

Enrollment: 10
Study Start Date: January 2011
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Children receiving meropenem
Children aged from 3 months to 18 years that receive treatment with meropenem.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Months to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: January 31, 2011
First Posted: February 3, 2011
Last Update Posted: November 6, 2014
Last Verified: November 2014

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

Additional relevant MeSH terms:
Bacterial Infections
Meropenem
Thienamycins
Anti-Bacterial Agents
Anti-Infective Agents