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Azole Antifungal

Posaconazole for Fungal Infection

Phase 2

Recruiting

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

Has a central line (eg, central venous catheter, peripherally-inserted central catheter) in place or planned to be in place before beginning IV study intervention

If enrolled with a proven IFI diagnosis, sampling of normally sterile tissue has shown fungal elements by cytology or microscopy, or sampling of normally sterile tissue or blood has yielded a positive culture for a fungal pathogen

Must not have

Has any known history of torsade de pointes, unstable cardiac arrhythmia or proarrhythmic conditions, a history of recent myocardial infarction, congenital or acquired QT interval (QT) prolongation, or cardiomyopathy in the context of cardiac failure within 90 days of first dose of study intervention

Has known or suspected Gilbert disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up predose and 0.25 post-infusion on day 1; weeks 1, 2, 4, 6, 9, and 12

Awards & highlights

No Placebo-Only Group

Summary

This trial will study how a drug called posaconazole works in young children with a fungal infection.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Posaconazole may cause side effects like headache, nausea, vomiting, diarrhea, abdominal pain and can affect liver enzymes. Rare but serious effects include heart rhythm problems and allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have or will have a central line placed for IV treatments.

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I have a confirmed fungal infection diagnosed through tissue or blood tests.

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My body weight is at least 500 grams.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of serious heart rhythm problems or recent heart attack.

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I have or might have Gilbert's syndrome.

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I have a hereditary sugar digestion problem.

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I have serious liver problems.

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I have been diagnosed with invasive candidiasis.

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I have a hereditary sugar digestion problem.

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I have cystic fibrosis, pulmonary sarcoidosis, aspergilloma, or allergic bronchopulmonary aspergillosis.

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I have received POS within the last 30 days.

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I currently have or might have COVID-19.

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I am not expected to live more than 5 days due to unstable blood pressure or circulation.

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I have a fungal infection that hasn't improved after 30 days or more of treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ predose and 0.25 post-infusion on day 1; weeks 1, 2, 4, 6, 9, and 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~predose and 0.25 post-infusion on day 1; weeks 1, 2, 4, 6, 9, and 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and predose and 0.25 post-infusion on 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

AUC0-24 of multiple-dose IV POS (Panel B)

AUC0-24 of multiple-dose PFSPOS (Panel B)

Area under the plasma concentration-time curve from dosing to 24 hours postdose (AUC0-24) of single-dose IV POS (Panel A)

+11 more

Secondary study objectives

Cavg of IV POS in neonates and infants <2 years of age compared to adults and older pediatric populations (Panel B)

Percentage of participants who discontinued study therapy due to an AE (Panels A and B)

Percentage of participants with a drug-related AE (Panels A and B)

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Panel B: POS PFSExperimental Treatment1 Intervention

Following a minimum of 7 days IV dosing, participants as clinically able will be transitioned from POS IV to POS PFS nominal 6 mg/kg body weight based on weight bands administered on Day 8, once daily to a maximum 84 days.

Group II: Panel B: POS IVExperimental Treatment1 Intervention

Posaconazole 6 mg/kg body weight administered twice daily by IV infusion on Day 1, and then once daily from Day 2 to a maximum 84 days.

Group III: Panel A: POS IVExperimental Treatment1 Intervention

Posaconazole 6 mg/kg body weight administered in a single dose by IV infusion on Day 1.

0 / 14Eligibility criteria met