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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

Study 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.Check my eligibility
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.See study design
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

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

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
4,581,797 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
3,886 Previous Clinical Trials
5,054,522 Total Patients Enrolled
1 Trials studying Invasive Aspergillosis
100 Patients Enrolled for Invasive Aspergillosis
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,777 Previous Clinical Trials
8,063,455 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has research on Posaconazole Plasma Free Concentration been conducted previously?

"Presently, there are 9 clinical trials that examine Posaconazole PFS with 2 of them in the final phase. Most studies pertaining to this treatment are located in Brussels, Bruxelles-Capitale, Region De and a total of 110 sites have been established for research on it."

Answered by AI

What medical conditions necessitate the use of Posaconazole PFS?

"Posaconazole PFS can be deployed to manage HIV, candidiasis, and other ailments resulting from weakened immunity."

Answered by AI

What is the size of the current participant cohort for this research?

"Affirmative. Clinicaltrials.gov points to this experiment as actively seeking patients, having been uploaded on July 2nd 2020 and most recently revised November 29th 2022. To complete the trial, 30 individuals must be recruited from 3 separate research centres."

Answered by AI

Does the age criterion for this experiment cap at 45 years old?

"This trial is seeking participants that are within the age range of 2 to 18 years old."

Answered by AI

Are there still open slots for participation in this research?

"According to the clinicaltrials.gov listing, this medical trial is still open for recruitment and was initially posted on July 2nd 2020 with a most recent edit taking place November 29th 2022."

Answered by AI

Are there any specific characteristics of participants that make them better suited for this trial?

"This clinical trial seeks 30 minors afflicted with invasive aspergillosis. Eligible candidates must meet the following prerequisites: having one or more of the EORTC/MSG defined risks, a diagnosis consistent with an acute episode of IA (<30 days), weighting no less than 10 kgs, positive mycological and clinical test results per 2008 modified definitions, abstaining from heterosexual intercourse for males unless medically confirmed to be azoospermic (or using contraception if applicable) and female participants being neither pregnant nor breastfeeding nor potentially able to become pregnant without highly effective contraceptive methods tested within 24 hours before intake."

Answered by AI

What risks come with the employment of Posaconazole PFS?

"Though there is some evidence of Posaconazole PFS's safety, due to this being a Phase 2 trial and the lack of data supporting its efficacy, we assign it an overall score of 2."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Posaconazole (MK-5592) Intravenous and Oral in Children With Invasive Aspergillosis (IA) (MK-5592-104)
2020. "Posaconazole (MK-5592) Intravenous and Oral in Children With Invasive Aspergillosis (IA) (MK-5592-104)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04218851.
~7 spots leftby Apr 2025
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