40 Participants Needed

Posaconazole for Fungal Infection

Recruiting at 16 trial locations
TF
Overseen ByToll Free Number
Age: < 18
Sex: Any
Trial Phase: Phase 2
Sponsor: Merck Sharp & Dohme Corp.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 3 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This study aims to estimate the pharmacokinetics (PK) of posaconazole (POS, MK-5592) intravenous (IV) and powder for oral suspension (PFS) formulations in pediatric participants \<2 years of age with invasive fungal infection (IFI).

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it mentions that certain medications are prohibited before starting the study. It's best to discuss your current medications with the study team to see if any need to be adjusted.

Is posaconazole generally safe for humans?

Posaconazole, also known as Noxafil, is generally well tolerated by patients and is approved for use in treating and preventing fungal infections. It is available in different forms, including oral suspension, tablets, and intravenous solution, and has been shown to have good tolerability in clinical settings.12345

How is the drug Posaconazole different from other treatments for fungal infections?

Posaconazole is unique because it is a triazole antifungal drug that can be taken orally or intravenously and is effective against a wide range of fungi, including those resistant to other antifungal drugs like fluconazole and amphotericin B. It also offers a gastro-resistant tablet form that provides better absorption and consistent plasma levels, making it a preferred option for treating invasive fungal infections.13456

What data supports the effectiveness of the drug Posaconazole for fungal infections?

Posaconazole has been shown to be effective against a wide range of fungal infections, including those resistant to other treatments, and is particularly useful for preventing serious fungal infections in high-risk patients. Clinical trials and studies have demonstrated its effectiveness in treating infections like aspergillosis and candidiasis, and it is well-tolerated with few side effects.13457

Who Is on the Research Team?

MD

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Are You a Good Fit for This Trial?

This trial is for children under 2 years old with invasive fungal infections. They must have symptoms of an acute IFI episode, weigh at least 500g, and have a central line in place. Kids can't join if they've had posaconazole recently, cystic fibrosis, certain metabolic disorders, active COVID-19, liver dysfunction or known severe reactions to similar antifungals.

Inclusion Criteria

I have a fungal infection that is not candidiasis, and it responds to POS medication.
The participant (or legally acceptable representative) has provided documented informed consent for the study
I have had symptoms of a fungal infection for less than 30 days.
See 6 more

Exclusion Criteria

Has QTc prolongation at screening >500 msec
I have or might have Gilbert's syndrome.
I have a hereditary sugar digestion problem.
See 12 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive posaconazole IV and/or PFS formulations. In Panel A, a single dose of IV POS is administered. In Panel B, participants receive IV POS for a minimum of 7 days, then transition to PFS for up to 84 days.

Up to 84 days
Daily visits for IV administration initially, then weekly visits for monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Posaconazole
Trial Overview The study tests how the body processes two forms of posaconazole: intravenous (IV) and oral suspension (PFS), in young kids with fungal infections. It aims to understand the appropriate dosing by observing how the drug moves through their bodies.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Group I: Panel B: POS PFSExperimental Treatment1 Intervention
Group II: Panel B: POS IVExperimental Treatment1 Intervention
Group III: Panel A: POS IVExperimental Treatment1 Intervention

Posaconazole is already approved in European Union, United States, Canada for the following indications:

🇪🇺
Approved in European Union as Noxafil for:
🇺🇸
Approved in United States as Noxafil for:
🇨🇦
Approved in Canada as Noxafil for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Merck Sharp & Dohme Corp.

Lead Sponsor

Trials
2,287
Recruited
4,582,000+
Chirfi Guindo profile image

Chirfi Guindo

Merck Sharp & Dohme Corp.

Chief Medical Officer

Engineering degree from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis profile image

Robert M. Davis

Merck Sharp & Dohme Corp.

Chief Executive Officer since 2021

J.D. from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Merck Sharp & Dohme LLC

Lead Sponsor

Trials
4,096
Recruited
5,232,000+
Chirfi Guindo profile image

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis profile image

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Published Research Related to This Trial

Posaconazole is an orally active triazole antifungal that is currently undergoing phase III clinical trials for treating serious opportunistic fungal infections, such as aspergillosis and candidiasis.
In addition to its primary indications, preclinical studies suggest that posaconazole may also be effective against Cryptococcus neoformans, which causes cryptococcosis.
Posaconazole: SCH 56592.[2019]
Posaconazole demonstrated potent antifungal activity against a wide range of clinically important fungi, with MIC(50) and MIC(90) values of 0.063 microg/ml and 1 microg/ml, respectively, based on testing of approximately 19,000 strains across 45 laboratories.
It was particularly effective against resistant strains of Candida and Aspergillus spp., showing superior activity compared to other antifungal agents like itraconazole, fluconazole, and amphotericin B, making it a promising option for treating difficult fungal infections.
In vitro activities of posaconazole, fluconazole, itraconazole, voriconazole, and amphotericin B against a large collection of clinically important molds and yeasts.Sabatelli, F., Patel, R., Mann, PA., et al.[2022]
A study using MRI on adult and juvenile Beagle dogs showed that the intravenous administration of posaconazole (Noxafil) did not affect brain ventricle volume over three months, indicating its safety regarding brain development in older dogs.
The research highlighted significant natural variability in brain ventricle sizes among dogs, which is important for accurately interpreting the effects of treatments like posaconazole and supports its potential use in children over two years of age.
Magnetic resonance imaging assessment of the ventricular system in the brains of adult and juvenile beagle dogs treated with posaconazole IV Solution.Hines, CD., Song, X., Kuruvilla, S., et al.[2015]

Citations

Posaconazole: SCH 56592. [2019]
In vitro activities of posaconazole, fluconazole, itraconazole, voriconazole, and amphotericin B against a large collection of clinically important molds and yeasts. [2022]
Magnetic resonance imaging assessment of the ventricular system in the brains of adult and juvenile beagle dogs treated with posaconazole IV Solution. [2015]
Posaconazole: when and how? The clinician's view. [2013]
Posaconazole: a review of the gastro-resistant tablet and intravenous solution in invasive fungal infections. [2018]
Role of posaconazole in the treatment of oropharyngeal candidiasis. [2021]
Posaconazole. [2018]
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