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A New Dosing Regimen for Posaconazole Prophylaxis in Children Based on Body Surface Area

NCT02372357 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2015-03-03

No results posted yet for this study

Summary

A new prophylactic posaconazole dosing regimen of 120mg/m² tid is evaluated pharmacologically in children 13 years and younger, suffering from a hematologic malignancy.

Conditions

  • Hematological Malignancy

Interventions

DRUG

Posaconazole prophylaxis 120 mg/m² tid

Patients are receiving posaconazole to prevent invasive fungal infections in a dose of 120 mg/m² tid

PROCEDURE

Blood sampling

During steady state treatment with posaconazole (at least 7 days), 9 blood samples are taken via a central venous catheter to evaluate the pharmacokinetics of posaconazole.

Sponsors & Collaborators

  • Institutul Clinic Fundeni

    collaborator OTHER

  • Universitaire Ziekenhuizen KU Leuven

    lead OTHER

Principal Investigators

  • Anca Colita, MD · Institutul Clinic Fundeni, Bucarest, Romania

  • Kim Vanstraelen, PharmD · Catholic University Leuven, Leuven, Belgium

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
13 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2014-08-31
Completion
2014-10-31

Countries

  • Belgium
  • Romania

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02372357 on ClinicalTrials.gov