CGD invasive fungal infection
Conditions
Interventions
Patients will be screend before entering the trial during a regular visit to
the outpatient clinic. Blood samples will be taken and an ECG will be made.
On Day 10 and 20 after start of intake of PSZ
Sponsors
Universitair Medisch Centrum Sint Radboud
Eligibility
Age
2 Years to 17 Years
Inclusion criteria
Inclusion criteria: 1. Patient has CGD, rendering him/her at risk for invasive fungal infections hence requiring antifungal prophylaxis. 2. Patient is at least 2 years of age and younger than 17 years of age on the day of the first dosing. 3. Parents or legal representative, and children where appropriate, willing and able to give informed consent.
Exclusion criteria
Exclusion criteria: 1. Patient is suspected of an invasive fungal infection. 2. Therapy with any medicinal product for which an effect on posaconazol is expected (see Clinical Trial Protocol, appendix B, Table 1). If patient is undergoing therapy with any medicinal product which may be effected by posaconazol, the patient is included on condition that the investigator judges that the effects are not clinically relevant (see Clinical Trial Protocol, appendix B, Table 2). This should be clearly recorded. 3. Documented history of sensitivity/idiosyncrasy to posaconazol. 4. Results of serum biochemistry and hematology testing are not higher than 3x the upper limit of normal (see Clinical Trial Protocol, appendix A). If the results exceed these limits, the pa-tient is included on condition that the investigator judges that the deviations are not clinically relevant. This should be clearly recorded. 5. Relevant history or current condition that might interfere with drug absorption, distribution, metabolism or excretion. 6. Relevant history or presence of cardiovascular disorder or renal and hepatic dis-order. 7. History of or current abuse of drugs, alcohol or recreational substances. 8. Participation in a trial with an investigational drug within 60 days prior to the first dose.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Individual trough PSZ plasma concentrations, on basis of which the PSZ dosage for individual patients will be adjusted. Base on the results a dosage for future prophylaxis with PSZ in children with CGD will be defined. | — |
Secondary
| Measure | Time frame |
|---|---|
| Biochemical en hematological parameters of individual patients. Information from patients and/or parents about possible side-effects experienced during the trial. | — |
Countries
Netherlands
Outcome results
None listed