None listed
Conditions
Interventions
Posaconazole, intravenous infusion 6mg/kg, Intravenous (IV) administration, twice daily (BID) Day 1 y once daily (QD) since Day 2 to Day 7 + Posaconazole, Powder for Suspension (PFS) 6 mg/kg OR Posaconazole, tablet 300 mg, oral administration, once daily (QD) since Day 8 to Day 84
Sponsors
Merck Sharp & Dohme Corp., una subsidiaria de Merck & Co. Inc.,
Eligibility
Inclusion criteria
Inclusion criteria: 1. Has a diagnosis of possible, probable, or proven IA per modified 2008 European Organization for Research and Treatment of Cancer/Mycoses Study Group (EORTC/MSG) disease definitions 2. If enrolled with a possible or probable IA diagnosis, 3. If enrolled with a possible or probable IA diagnosis, meets mycologic and clinical criteria as per modified 2008 EORTC/MSG disease definitions 4. If enrolled with a proven IA diagnosis, has demonstrated fungal elements (by cytology or microscopy) or positive culture for Aspergillus obtained by sterile sampling of diseased tissue as per modified EORTC/MSG disease definitions 5. Has a central line (eg, central venous catheter, peripherally-inserted central catheter) in place or planned to be in place prior to beginning IV study treatment 6. Has clinical symptoms consistent with an acute episode of IA, defined as duration of clinical syndrome of <30 days 7. Is male or female, and ≥2 years of age and <18 years of age at the time of first dose of study treatment. Participants may be of any race/ethnicity 8. Male participants are eligible to participate if they agree to the following during the intervention period and for at least 30 days]: • Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent or • Must agree to use contraception 8. Male participants are eligible to participate if they agree to the following during the intervention period and for at least 30 days]: • Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent or • Must agree to use contraception 9. A female participant is eligible to participate if she is not pregnant or breastfeeding 10. The participant (or legally acceptable representative if applicable) provides written informed consent/assent for the study. The participant may also provide consent/assent for future biomedical research. However, the participant may participate in the main study without participating in future biomedical research Please refer to the protocol for more information
Exclusion criteria
Exclusion criteria: 1. Has chronic (≥30 days’ duration) IA, relapsed/recurrent IA, or refractory IA that has not responded to prior antifungal treatment 2. Has cystic fibrosis, pulmonary sarcoidosis, aspergilloma, or allergic bronchopulmonary aspergillosis 3. Has a known hypersensitivity or other serious adverse reaction to any azole antifungal therapy, or to any other ingredient of the study treatment used 4. 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 5. Has a known hereditary problem of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption 6. Is on artificial ventilation or receiving acute continuous positive airway pressure (CPAP)/bilevel positive airway pressure (BPAP) at the time of first dose of study treatment 7. Has known or suspected Gilbert’s disease 8. Has any condition that, in the opinion of the investigator, may interfere with optimal participation in the study 9. A WOCBP who has a positive urine pregnancy test within 72 hours before the first doce of study intervention or at any time during the study. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required 10. Has received any treatment specifically listed in Table 1 (see protocol) within the specified timeframes prior to the start of study treatment 11. Has enrolled previously in the current study and been discontinued 12. Has QTc prolongation (based on either Fridericia or Bazett’s correction) at screening >500 msec 13. Has significant liver dysfunction (defined as total bilirubin >1.5 times ULN AND AST or ALT >3 times ULN with normal alkaline phosphatase) at screening 14. Has calculated creatinine clearance <20 mL/min (Cockroft-Gault formula) or <20 mL/min/1.73m2 (modified Schwartz formula) at screening 15. Is not expected, in the opinion of the investigator, to survive for at least 1 month after the initiation of study treatment 16. 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 Please refer to the protocol for more information
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Clopper-Pearson Method Measure:Proportion of adverse events (AE) and Discontinuation of study intervention due to AEs. Timepoints:From the treatment period (IV and oral treatment phases) plus 14 days of follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Clopper-Pearson Method Measure:Proportion of participants in the FAS population with a favorable global clinical response Timepoints:At the Week 6 (Day 42) Visit, at the Week 12 (Day 84) Visit, and at the End of Treatment Visit (if different). ; Outcome name:Descriptive Statistics Measure:Pharmacokinetic parameters Timepoints:Time points: At the Day 1, week 1, 2, 4, 6, 9 and 12 after study treatment administration. ; Outcome name:Descriptive Statistics Measure:Proportion of participants in the Responder Population who have a relapse of IA Timepoints:At any point after achieving favorable global clinical response through 28 days post-treatment | — |
Countries
Belgium, Czech Republic, Greece, Hungary, Israel, Italy, Korea South, Mexico, Peru, Russian Federation, United States
Contacts
Public ContactNelva Garcia
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed