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Azole Antifungal

Posaconazole for Aspergillosis

Phase 2
Waitlist Available
Research Sponsored by Merck Sharp & Dohme Corp.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-dose, day 1, weeks 1, 2, 4, 6, 9 and 12
Awards & highlights
No Placebo-Only Group

Summary

This trial will study how well posaconazole works in children with aspergillosis, a fungal infection.

Who is the study for?
Children aged 2 to <18 with invasive aspergillosis can join this trial. They must have a diagnosis of IA, show clinical symptoms for less than 30 days, weigh at least 10 kg, and use contraception if applicable. Kids with cystic fibrosis or known allergies to azole antifungals, on ventilation, or not expected to survive one month post-treatment are excluded.
What is being tested?
The study tests the safety and effectiveness of Posaconazole in IV and oral forms for treating pediatric invasive aspergillosis. It will also look at how children's bodies absorb and process the medication.
What are the potential side effects?
Posaconazole may cause side effects like headaches, nausea, vomiting, diarrhea, liver problems (like increased liver enzymes), fever, rash or other allergic reactions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-dose, day 1, weeks 1, 2, 4, 6, 9 and 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-dose, day 1, weeks 1, 2, 4, 6, 9 and 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Participants with Treatment Related Adverse Events (AEs)
Secondary study objectives
Area under the concentration-time curve (AUC) of POS
Average plasma concentration (Cavg) of Posaconazole (POS)
Maximum plasma concentration (Cmax) of POS
+5 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: PosaconazoleExperimental Treatment3 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Posaconazole IV
2020
Completed Phase 2
~40
Posaconazole PFS
2020
Completed Phase 2
~40
Posaconazole tablet
2020
Completed Phase 2
~40

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,582,327 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
3,985 Previous Clinical Trials
5,178,670 Total Patients Enrolled
1 Trials studying Invasive Aspergillosis
100 Patients Enrolled for Invasive Aspergillosis
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,868 Previous Clinical Trials
8,082,599 Total Patients Enrolled
1 Trials studying Invasive Aspergillosis
43 Patients Enrolled for Invasive Aspergillosis

Media Library

Posaconazole (Azole Antifungal) Clinical Trial Eligibility Overview. Trial Name: NCT04218851 — Phase 2
Invasive Aspergillosis Research Study Groups: Posaconazole
Invasive Aspergillosis Clinical Trial 2023: Posaconazole Highlights & Side Effects. Trial Name: NCT04218851 — Phase 2
Posaconazole (Azole Antifungal) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04218851 — Phase 2
~6 spots leftby Nov 2025
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