This study will evaluate the safety, efficacy, and pharmacokinetics of posaconazole (POS) intravenous (IV) and oral formulations in pediatric participants 2 to \<18 years of age with invasive aspergillosis (IA).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
31
Posaconazole (POS) 6 mg/kg body weight by IV infusion
Dosing based on weight-band taken orally
POS tablet 300 mg taken orally
Percentage of Participants Who Experience One or More Treatment-related Adverse Events (AEs)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. Treatment-related AEs were determined by the investigator to be related to the drug. The 95% confidence interval (CI) was based on the exact binomial method by Clopper- Pearson.
Time frame: Up to 14 days after treatment (up to Day 102)
Percentage of Participants Who Have a Favorable Global Clinical Response Through Week 6
A global clinical response is assessed by the investigator as favorable if the participant is alive and has a complete response (CR) or partial response (PR). CR is defined as survival within the prespecified period of observation, resolution of all attributable symptoms and signs of disease, resolution of radiological lesion(s), and documented clearance of infected sites that are accessible to repeated sampling. PR is defined as survival within the prespecified period of observation, improvement in attributable symptoms and signs of disease, improvement of radiological lesion(s), and evidence of clearance of infected sites that are accessible to repeated sampling.
Time frame: Up to week 6
Percentage of Participants Who Have a Favorable Global Clinical Response Through Week 12
A global clinical response is assessed by the investigator as favorable if the participant is alive and has a complete response (CR) or partial response (PR). CR is defined as survival within the prespecified period of observation, resolution of all attributable symptoms and signs of disease, resolution of radiological lesion(s), and documented clearance of infected sites that are accessible to repeated sampling. PR is defined as survival within the prespecified period of observation, improvement in attributable symptoms and signs of disease, improvement of radiological lesion(s), and evidence of clearance of infected sites that are accessible to repeated sampling.
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Children's Hospital of Orange County ( Site 1409)
Orange, California, United States
Rady Children's Hospital-San Diego ( Site 1401)
San Diego, California, United States
Ann & Robert H. Lurie Children's Hospital of Chicago ( Site 1402)
Chicago, Illinois, United States
Washington University ( Site 1403)
St Louis, Missouri, United States
UCL St Luc ( Site 1000)
Brussels, Bruxelles-Capitale, Region de, Belgium
UZ Gent ( Site 1002)
Ghent, Oost-Vlaanderen, Belgium
UZ Leuven ( Site 1001)
Leuven, Vlaams-Brabant, Belgium
Athens Childrens Hospital Aglaia Kyriakou ( Site 1052)
Athens, Attica, Greece
University General Hospital of Thessaloniki "AHEPA" ( Site 1053)
Thessaloniki, Central Macedonia, Greece
General Hospital of Thessaloniki "Ippokrateio" ( Site 1050)
Thessaloniki, Greece
...and 19 more locations
Time frame: Up to Week 12
Percentage of Participants Who Have a Relapse of Invasive Aspergillosis (IA) at Any Point After Achieving Favorable Global Clinical Response
In participants who achieved favorable global clinical response, relapse of IA is defined as the re-emergence of clinical, radiographic, or other relevant abnormalities indicating IA.
Time frame: Up to 28 days post-treatment (up to Day 116)
Average Plasma Concentration (Cavg) of POS by Age Cohorts
Steady state Cavg was determined by population PK analysis of plasma concentrations obtained pre-dose up to Week 12 for each of Cohorts 1 and 2, as well as the pooled Cohorts 1 and 2. Some participants had 2 Cavg parameter values (1 for IV dosing, 1 for oral dosing).
Time frame: Pre-dose, Day 1, Weeks 1, 2, 4, 6, 9 and 12
Minimum Plasma Concentration (Cmin) of POS by Age Cohorts
Steady state Cmin was determined by population PK analysis of plasma concentrations obtained pre-dose up to Week 12 for each of Cohorts 1 and 2, as well as the pooled Cohorts 1 and 2. Some participants had 2 Cmin parameter values (1 for IV dosing, 1 for oral dosing).
Time frame: Pre-dose, Day 1, Weeks 1, 2, 4, 6, 9 and 12
Maximum Plasma Concentration (Cmax) of POS by Age Cohorts
Steady state Cmax was determined by population PK analysis of plasma concentrations obtained pre-dose up to Week 12 for each of Cohorts 1 and 2, as well as the pooled Cohorts 1 and 2. Some participants had 2 Cmax parameter values (1 for IV dosing, 1 for oral dosing).
Time frame: Pre-dose, Day 1, Weeks 1, 2, 4, 6, 9 and 12
Area Under the Concentration Time Curve Over the Dosing Interval (AUCtau) of POS by Age Cohorts
Steady state AUCtau was determined by population PK analysis of plasma concentrations obtained pre-dose up to Week 12 for each of Cohorts 1 and 2, as well as the pooled Cohorts 1 and 2. Some participants had 2 AUCtau parameter values (1 for IV dosing, 1 for oral dosing).
Time frame: Pre-dose, Day 1, Weeks 1, 2, 4, 6, 9 and 12
Time to Reach Cmax (Tmax) of POS by Age Cohorts
Steady state Tmax was determined by population PK analysis of plasma concentrations obtained pre-dose up to Week 12 for each of Cohorts 1 and 2, as well as the pooled Cohorts 1 and 2. Some participants had 2 Tmax parameter values (1 for IV dosing, 1 for oral dosing).
Time frame: Pre-dose, Day 1, Weeks 1, 2, 4, 6, 9 and 12
Average Plasma Concentration (Cavg) of POS by Formulation
Steady-state Cavg was determined by population PK analysis from plasma concentration obtained pre-dose up to Week 12 for each of the POS formulations: IV, PFS and tablet. Some participants may have received more than 1 formulation, and results were only reported when N \> 2.
Time frame: Pre-dose, Day 1, Weeks 1, 2, 4, 6, 9 and 12
Minimum Plasma Concentration (Cmin) of POS by Formulation
Steady-state Cmin was determined by population PK analysis from plasma concentration obtained pre-dose up to Week 12 for each of the POS formulations: IV, PFS and tablet. Some participants may have received more than 1 formulation, and results were only reported when N \> 2.
Time frame: Pre-dose, Day 1, Weeks 1, 2, 4, 6, 9 and 12
Maximum Plasma Concentration (Cmax) of POS by Formulation
Steady-state Cmax was determined by population PK analysis from plasma concentration obtained pre-dose up to Week 12 for each of the POS formulations: IV, PFS and tablet. Some participants may have received more than 1 formulation, and results were only reported when N \> 2.
Time frame: Pre-dose, Day 1, Weeks 1, 2, 4, 6, 9 and 12
Area Under the Concentration Time Curve Over the Dosing Interval (AUCtau) of POS by Formulation
Steady-state AUCtau was determined by population PK analysis from plasma concentration obtained pre-dose up to Week 12 for each of the POS formulations: IV, PFS and tablet. Some participants may have received more than 1 formulation, and results were only reported when N \> 2.
Time frame: Pre-dose, Day 1, Weeks 1, 2, 4, 6, 9 and 12
Time to Reach Cmax (Tmax) of POS by Formulation
Steady-state Tmax was determined by population PK analysis from plasma concentration obtained pre-dose up to Week 12 for each of the POS formulations: IV, PFS and tablet. Some participants may have received more than 1 formulation, and results were only reported when N \> 2.
Time frame: Pre-dose, Day 1, Weeks 1, 2, 4, 6, 9 and 12
Percentage of Participants With Different Categories of Palatability After First Day of Treatment With the POS PFS Formulation
Palatability was categorized on the first day (Day 8) on PFS based on responses by participants to a palatability questionnaire. Per protocol participants were pooled into a single treatment group. Palatability categories for taste are as follows: Very good; Good; Very bad; Neither good nor bad.
Time frame: First day of PFS treatment (Day 8)
Percentage of Participants With Different Categories of Palatability After Last Day of Treatment With the POS PFS Formulation
Palatability was categorized on the last day (Day 85) on PFS based on responses by participants to a palatability questionnaire. Per protocol participants were pooled into a single treatment group Palatability categories for taste are as follows: Very good; Good; Very bad; Neither good nor bad.
Time frame: Last day of PFS treatment (Day 85)