NCT02372357

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Feb 2012

Typical duration for phase_4

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 6, 2015

Completed
20 days until next milestone

First Posted

Study publicly available on registry

February 26, 2015

Completed
Last Updated

March 3, 2015

Status Verified

March 1, 2015

Enrollment Period

2.5 years

First QC Date

February 6, 2015

Last Update Submit

March 2, 2015

Conditions

Hematological Malignancy

Keywords

chemotherapystem cell transplantation

Outcome Measures

Primary Outcomes (1)

  • pharmacokinetic parameters of posaconazole

    9 blood samples are taken during one day at steady state posaconazole plasma concentrations. The following pharmacokinetic parameters will be calculated using non-compartmental pharmacokinetic analysis: Cmax, Cmin, Tmax, Area Under the Curve during 1 dosing interval and over 24 hours, Clearance, Distribution volume, Halflife.

    One day at steady state posaconazole treatment

Secondary Outcomes (2)

  • Safety of posaconazole, focussing on nausea, vomiting and liver function abnormalities (according to the Common Terminology Criteria for Adverse Events (CTCAE classification).

    patients will be followed for the duration of hospital stay, an expected average of 3-4 weeks

  • Efficacy: patients are monitored for breakthrough infections according the the European Organisation for Research and Treatment of Cancer- Mycoses Study Group (EORTC-MSG) criteria.

    patients will be followed for the duration of hospital stay, an expected average of 3-4 weeks

Study Arms (1)

Posaconazole 120mg/m² tid

EXPERIMENTAL

Pediatric patients admitted to receive chemotherapy or hematopoietic stem cell transplantation for the treatment of a hematological malignancy are receiving Posaconazole prophylaxis 120 mg/m² tid. At steady state, blood sampling will be performed: 9 blood samples will be taken during 1 dosing interval to evaluate the pharmacokinetics of posaconazole.

Drug: Posaconazole prophylaxis 120 mg/m² tidProcedure: Blood sampling

Interventions

Posaconazole prophylaxis 120 mg/m² tidDRUG

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

Posaconazole 120mg/m² tid
Blood samplingPROCEDURE

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.

Posaconazole 120mg/m² tid

Eligibility Criteria

Age2 Years - 13 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • years of age
  • hematological malignancy
  • need for antifungal prophylaxis because of neutropenia caused by chemotherapy and/or hematopoietic stem cell transplantation.

You may not qualify if:

  • \<2 years of age
  • \> 13 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Catholic University Leuven - Department of Pharmaceutical and Pharmacological Sciences

Leuven, Vlaams-Brabant, 3000, Belgium

Location

Institutul Clinic Fundeni

Bucharest, Sector 2, 023808, Romania

Location

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Anca Colita, MD

    Institutul Clinic Fundeni, Bucarest, Romania

    PRINCIPAL INVESTIGATOR

  • Kim Vanstraelen, PharmD

    Catholic University Leuven, Leuven, Belgium

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PharmD

Study Record Dates

First Submitted

February 6, 2015

First Posted

February 26, 2015

Study Start

February 1, 2012

Primary Completion

August 1, 2014

Study Completion

October 1, 2014

Last Updated

March 3, 2015

Record last verified: 2015-03

Locations

RO(1)BE(1)