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Optimalisation of vancomycine dosage regimens in pediatric patients

Optimalisation of vancomycine dosage regimens in pediatric patients - VANCOPED

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON30777
Enrollment
200
Registered
2007-08-28
Start date
2006-06-15
Completion date
Unknown
Last updated
2024-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

blood poisoning serious infection

Interventions

Half of the included number of patients will receive a higher vancomycin dosage at the start of therapy. However this dosage is within the limits of the normal dosage range.

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
2 Years to 17 Years

Inclusion criteria

Inclusion criteria: - children (age 0 to 18 yrs) - suspected or proven systemic infection with Gram-positive bacteria (incl. indwelling catheter infection) treated with intravenous vancomycin - written informed consent signed by both parents or the legal representative(s)

Exclusion criteria

Exclusion criteria: - renal failure (defined as a plasma creatinine concentration above the age corrected normal value) - renal replacement therapy

Design outcomes

Primary

MeasureTime frame
During the study the following data will be collected centrally as part of the clinical research file: - length, body weight, age (for neonates also gestational age) - patient category (oncology, intensive car, neonate, other) - renal function (serum creatinine, blood urea nitrogen), fluid balance (if recorded as part of routine care) - reason for starting intravenous vancomycine therapy, dosage (dose en precise times of administration) - vancomycine serum concentrations, precise times of sampling, type of material - body temperature at the time of vancomycin administration - susceptibility and/or MIC of grown pathogens (bacteria) - registration of reported adverse effects

Secondary

MeasureTime frame
n.a.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)