Phase 2
N=31
Posaconazole (MK-5592) Intravenous and Oral in Children With Invasive Aspergillosis (IA) (MK-5592-104)
Invasive Aspergillosis
Bottom Line
View on ClinicalTrials.gov: NCT04218851 ↗Enrolled (actual)
31
Serious AEs
38.7%
Results posted
Jan 2025
Primary outcome: Primary: Percentage of Participants Who Experience One or More Treatment-related Adverse Events (AEs) — 14.3; 29.4 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Posaconazole IV (Drug); Posaconazole PFS (Drug); Posaconazole tablet (Drug)
- Age
- Pediatric · 2+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Dec 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Experience One or More Treatment-related Adverse Events (AEs) |
14.3; 29.4 | — |
| SECONDARY Percentage of Participants Who Have a Favorable Global Clinical Response Through Week 6 |
42.9; 17.6; 21.4; 52.9 | — |
| SECONDARY Percentage of Participants Who Have a Favorable Global Clinical Response Through Week 12 |
57.1; 41.2; 21.4; 35.3 | — |
| SECONDARY Percentage of Participants Who Have a Relapse of Invasive Aspergillosis (IA) at Any Point After Achieving Favorable Global Clinical Response |
0; 0 | — |
| SECONDARY Average Plasma Concentration (Cavg) of POS by Age Cohorts |
2590; 2770; 2700 | — |
| SECONDARY Minimum Plasma Concentration (Cmin) of POS by Age Cohorts |
1610; 1920; 1790 | — |
| SECONDARY Maximum Plasma Concentration (Cmax) of POS by Age Cohorts |
3620; 3610; 3610 | — |
| SECONDARY Area Under the Concentration Time Curve Over the Dosing Interval (AUCtau) of POS by Age Cohorts |
62200; 66400; 64700 | — |
| SECONDARY Time to Reach Cmax (Tmax) of POS by Age Cohorts |
1.68; 1.63; 1.63 | — |
| SECONDARY Average Plasma Concentration (Cavg) of POS by Formulation |
2900; 2070; NA; 2860; NA; 2500 | — |
| SECONDARY Minimum Plasma Concentration (Cmin) of POS by Formulation |
1680; 1410; NA; 1820; NA; 1910 | — |
| SECONDARY Maximum Plasma Concentration (Cmax) of POS by Formulation |
4530; 2510; NA; 4180; NA; 2880 | — |
| SECONDARY Area Under the Concentration Time Curve Over the Dosing Interval (AUCtau) of POS by Formulation |
69600; 49700; NA; 68600; NA; 60100 | — |
| SECONDARY Time to Reach Cmax (Tmax) of POS by Formulation |
1.50; 7.00; NA; 1.50; NA; 7.20 | — |
| SECONDARY Percentage of Participants With Different Categories of Palatability After First Day of Treatment With the POS PFS Formulation |
20; 40; 10; 30 | — |
| SECONDARY Percentage of Participants With Different Categories of Palatability After Last Day of Treatment With the POS PFS Formulation |
10; 40; 10; 40 | — |
Summary
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).
Eligibility Criteria
Inclusion Criteria
- Has a diagnosis of possible, probable, or proven IA per modified 2008/2020 European Organization for Research and Treatment of Cancer/Mycoses Study Group (EORTC/MSG) disease definitions
- Has one or more of pre-defined risks as per modified 2008 EORTC/MSG disease definitions
- Has a central line (e.g., central venous catheter, peripherally-inserted central catheter) in place or planned to be in place prior to beginning IV study treatment.
- Has clinical symptoms consistent with an acute episode of IA, defined as duration of clinical syndrome of <30 days.
- Participants weigh at least 10 kg, and may be of any race/ethnicity.
- During the intervention period and for at least 30 days after the last dose of study treatment, males agree to be abstinent from heterosexual intercourse or use contraception unless confirmed to be azoospermic (vasectomized or secondary to medical cause).
- Female is not pregnant or breastfeeding, and is not a woman of child bearing potential (WOCBP) or is a WOCBP using a highly effective contraceptive method. A WOCBP must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) within 24 hours before the first dose of study intervention.
Exclusion Criteria
- Has chronic (≥30 days' duration) IA, relapsed/recurrent IA, or refractory IA that has not responded to prior antifungal treatment.
- Has cystic fibrosis, pulmonary sarcoidosis, aspergilloma, or allergic bronchopulmonary aspergillosis
- Has a known hypersensitivity or other serious adverse reaction to any azole antifungal therapy, or to any other ingredient of the study treatment used.
- Has any known history of torsade de pointes, unstable cardiac arrhythmia or proarrhythmic conditions, a history of recent myocardial infarction, congenital or acquired QT prolongation, or cardiomyopathy in the context of cardiac failure within 90 days of time of first dose of study treatment.
- Has known hereditary fructose intolerance.
- Has a known hereditary problem of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
- Is or has an immediate family member (eg, spouse, parent/legal guardian, sibling, or child) who is investigational site or Sponsor staff directly involved with this study.
- Is on artificial ventilation at the time of first dose of study treatment.
- Has received any treatment prohibited by the protocol.
- Has enrolled previously in the current study and been discontinued.
- Is not expected, in the opinion of the investigator, to survive for at least 1 month after the initiation of study treatment.
Data sourced from ClinicalTrials.gov (NCT04218851). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.