NCT00799071

Brief Summary

The purpose of this study is to find a dose for a twice daily regimen for posaconazole (PSZ) as prophylactic treatment in children with CGD, based on the PSZ trough level.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Feb 2009

Shorter than P25 for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 26, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 27, 2008

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2009

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

November 30, 2020

Status Verified

November 1, 2020

Enrollment Period

1.4 years

First QC Date

November 26, 2008

Last Update Submit

November 26, 2020

Conditions

Chronic Granulomatous Disease

Keywords

prophylaxisCGDpharmacokinetics

Outcome Measures

Primary Outcomes (1)

  • Posaconazole trough levels

    Day 10; 20; 30

Secondary Outcomes (1)

  • adverse events monitoring

    entire study

Study Arms (1)

posaconazole

EXPERIMENTAL

posaconazole as antifungal prophylaxis

Drug: posaconazole (PSZ)

Interventions

posaconazole (PSZ)DRUG

Intake of PSZ oral suspension 40mg/ml twice daily with food. Starting dose is based on bodyweight. The dosage will be adjusted if the exposure is not adequate based on PSZ trough level on Day 10 and 20.

Also known as: Noxafil
posaconazole

Eligibility Criteria

Age2 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Patient has CGD, rendering him/her at risk for invasive fungal infections hence requiring antifungal prophylaxis.
  • Patient is at least 2 years of age and younger than 17 years of age on the day of the first dosing.
  • Parents or legal representative, and children where appropriate, willing and able to give informed consent.

You may not qualify if:

  • Patient is suspected of an invasive fungal infection.
  • Therapy with any medicinal product for which an effect on PSZ is expected. If patient is undergoing therapy with any medicinal product which may be effected by PSZ, the patient is included on condition that the investigator judges that the effects are not clinically relevant. This should be clearly recorded.
  • Documented history of sensitivity/idiosyncrasy to PSZ.
  • Results of serum biochemistry and hematology testing are not higher than 3x the upper limit of normal. If the results exceed these limits, the patient is included on condition that the investigator judges that the deviations are not clinically relevant. This should be clearly recorded.
  • Relevant history or current condition that might interfere with drug absorption, distribution, metabolism or excretion.
  • Relevant history or presence of cardiovascular disorder or renal and hepatic disorder.
  • History of or current abuse of drugs, alcohol or recreational substances.
  • Participation in a trial with an investigational drug within 60 days prior to the first dose.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Radboud University Medical Centre Nijmegen

Nijmegen, Gelderland, Netherlands

Location

AMC

Amsterdam, Netherlands

Location

Related Publications (1)

  • Welzen ME, Bruggemann RJ, Van Den Berg JM, Voogt HW, Gilissen JH, Pajkrt D, Klein N, Burger DM, Warris A. A twice daily posaconazole dosing algorithm for children with chronic granulomatous disease. Pediatr Infect Dis J. 2011 Sep;30(9):794-7. doi: 10.1097/INF.0b013e3182195808.

    PMID: 21772229RESULT

Related Links

MeSH Terms

Conditions

Granulomatous Disease, Chronic

Interventions

posaconazole

Condition Hierarchy (Ancestors)

Phagocyte Bactericidal DysfunctionLeukocyte DisordersHematologic DiseasesHemic and Lymphatic DiseasesGenetic Diseases, X-LinkedGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesImmunologic Deficiency SyndromesImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • David M Burger, PharmD PhD

    Radboud University Medical Centre Nijmegen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 26, 2008

First Posted

November 27, 2008

Study Start

February 1, 2009

Primary Completion

July 1, 2010

Study Completion

August 1, 2010

Last Updated

November 30, 2020

Record last verified: 2020-11

Locations

NL(2)