Posaconazole (MK-5592) Intravenous and Oral in Children With Invasive Aspergillosis (IA) (MK-5592-104)
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|ClinicalTrials.gov Identifier: NCT04218851|
Recruitment Status : Recruiting
First Posted : January 6, 2020
Last Update Posted : February 10, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Invasive Aspergillosis||Drug: Posaconazole IV Drug: Posaconazole PFS Drug: Posaconazole tablet||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2, Open-Label, Non-Comparative Clinical Trial to Study the Safety and Efficacy of Posaconazole (POS, MK-5592) in Pediatric Participants Aged 2 to Less Than 18 Years With Invasive Aspergillosis|
|Actual Study Start Date :||July 2, 2020|
|Estimated Primary Completion Date :||December 29, 2023|
|Estimated Study Completion Date :||December 29, 2023|
On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral formulation, or they may remain on the IV formulation.
Drug: Posaconazole IV
Posaconazole (POS) 6 mg/kg body weight by IV infusion
Drug: Posaconazole PFS
POS PFS 6 mg/kg body weight taken orally
Drug: Posaconazole tablet
POS tablet 300 mg taken orally
- Participants with Treatment Related Adverse Events (AEs) [ Time Frame: Up to 14 days after treatment (up to Day 100) ]Percentage of participants who experience one or more treatment-related adverse events (AEs)
- Participants with a favorable global clinical response [ Time Frame: Up to End of Trial (EOT) visit (up to Day 87) ]Percentage of participants who have a favorable global clinical response
- Participants who have a relapse of invasive aspergillosis (IA) [ Time Frame: Up to 28 days post-treatment (up to Day 114) ]Percentage of participants who have a relapse of invasive aspergillosis (IA) at any point after achieving favorable global clinical response
- Average plasma concentration (Cavg) of Posaconazole (POS) [ Time Frame: Pre-dose, Day 1, Weeks 1, 2, 4, 6, 9 and 12 ]Average plasma concentration (Cavg) of Posaconazole (POS)
- Minimum plasma concentration (Cmin) of POS [ Time Frame: Pre-dose, Day 1, Weeks 1, 2, 4, 6, 9 and 12 ]Minimum plasma concentration (Cmin) of POS
- Maximum plasma concentration (Cmax) of POS [ Time Frame: Pre-dose, Day 1, Weeks 1, 2, 4, 6, 9 and 12 ]Maximum plasma concentration (Cmax) of POS
- Area under the concentration-time curve (AUC) of POS [ Time Frame: Pre-dose, Day 1, Weeks 1, 2, 4, 6, 9 and 12 ]Area under the concentration-time curve (AUC) of POS
- Time to reach Cmax (Tmax) of POS [ Time Frame: Pre-dose, Day 1, Weeks 1, 2, 4, 6, 9 and 12 ]Time to reach Cmax (Tmax) of POS
- Participants with different categories of palatability [ Time Frame: Day 8 and Day 84 ]Percentage of participants with different categories of palatability after treatment with the POS PFS formulation
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|Ages Eligible for Study:||2 Years to 18 Years (Child, Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- Has one or more of pre-defined risks as per modified 2008 EORTC/MSG disease definitions
- Meets pre-defined mycologic and clinical criteria as per modified 2008 EORTC/MSG disease definitions
- Has demonstrated fungal elements (by cytology or microscopy) or positive culture for Aspergillus obtained by sterile sampling of disease tissue as per modified 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 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.
- 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 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04218851
|Contact: Toll Free Number||1-888-577-8839||Trialsites@merck.com|
|Study Director:||Medical Director||Merck Sharp & Dohme LLC|
|Responsible Party:||Merck Sharp & Dohme LLC|
|Other Study ID Numbers:||
MK-5592-104 ( Other Identifier: Merck )
2019-002267-10 ( EudraCT Number )
|First Posted:||January 6, 2020 Key Record Dates|
|Last Update Posted:||February 10, 2023|
|Last Verified:||February 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Yes|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
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