Posaconazole IV 6 mg/kg for Invasive Fungal Infections

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Invasive Fungal InfectionsPosaconazole IV 6 mg/kg - Drug
Eligibility
1 - 2
All Sexes
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Study Summary

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

Eligible Conditions
  • Invasive Fungal Infections

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

18 Primary · 6 Secondary · Reporting Duration: Predose and 0.25 post-infusion on Day 1; Weeks 1, 2, 4, 6, 9, and 12

Week 1
AUC0-24 of multiple-dose IV POS (Panel B)
AUC0-24 of multiple-dose PFSPOS (Panel B)
AUC0-∞ of multiple-dose IV POS (Panel B)
AUC0-∞ of multiple-dose PFS POS (Panel B)
Cavg of IV POS in neonates and infants <2 years of age compared to adults and older pediatric populations (Panel B)
Cavg of multiple-dose IV POS (Panel B)
Cavg of multiple-dose PFS POS (Panel B)
Clearance (CL) of multiple-dose IV POS (Panel B)
Clearance (CL) of multiple-dose PFS POS (Panel B)
Cmax of multiple-dose IV POS (Panel B)
Cmax of multiple-dose PFS POS (Panel B)
Tmax of multiple-dose IV POS (Panel B)
Tmax of multiple-dose PFS POS (Panel B)
Day 1
Area under the plasma concentration-time curve from dosing to 24 hours postdose (AUC0-24) of single-dose IV POS (Panel A)
Area under the plasma concentration-time curve from dosing to infinity (AUC0-∞) of single-dose IV POS (Panel A)
Average concentration (Cavg) of single-dose IV POS (Panel A)
Clearance (CL) of single-dose IV POS (Panel A)
Maximum concentration (Cmax) of single-dose IV POS (Panel A)
Time to maximum concentration (Tmax) of single-dose IV POS (Panel A)
Up to 28 days
Percentage of participants with all-cause mortality (ACM) [Panel B]
Up to 84 days
Percentage of participants who discontinued study therapy due to an AE
Percentage of participants with need for systemic antifungal therapy (other than POS) during the study period (Panel B)
Up to 98 days
Percentage of participants with a drug-related AE
Percentage of participants with an ≥ 1 adverse event (AE)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

Panel A: POS IV
1 of 2
Panel B: POS IV/PFS
1 of 2

Experimental Treatment

40 Total Participants · 2 Treatment Groups

Primary Treatment: Posaconazole IV 6 mg/kg · No Placebo Group · Phase 2

Panel A: POS IV
Drug
Experimental Group · 1 Intervention: Posaconazole IV 6 mg/kg · Intervention Types: Drug
Panel B: POS IV/PFSExperimental Group · 2 Interventions: Posaconazole IV TBD, Posaconazole PFS TBD · Intervention Types: Drug, Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: predose and 0.25 post-infusion on day 1; weeks 1, 2, 4, 6, 9, and 12

Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,578,319 Total Patients Enrolled
13 Trials studying Invasive Fungal Infections
1,937 Patients Enrolled for Invasive Fungal Infections
Merck Sharp & Dohme LLCLead Sponsor
3,676 Previous Clinical Trials
4,959,884 Total Patients Enrolled
20 Trials studying Invasive Fungal Infections
3,597 Patients Enrolled for Invasive Fungal Infections
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,638 Previous Clinical Trials
7,941,891 Total Patients Enrolled
6 Trials studying Invasive Fungal Infections
3,486 Patients Enrolled for Invasive Fungal Infections

Eligibility Criteria

Age 1 - 2 · All Participants · 9 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
The patient has a central line in place or planned to have one in place before they start the IV study intervention.
The person has symptoms that are consistent with an acute infection caused by a fungus, which lasts for less than 30 days.
The participant has agreed to take part in the study after being told about it and has been given the opportunity to ask any questions.
Weighs at least 500 grams.
Panel B has a diagnosis of an IFI caused by a fungal pathogen for which POS has demonstrated activity.
, then patient is at high risk for IFI If a patient is enrolled with a possible or probable IFI diagnosis and also has one or more of the listed host factors, then the patient is at high risk for developing an IFI.
A person receiving treatment for a possible, probable, or proven infection caused by a fungus against which treatment with POS has been effective is known as being POS-treated.
, and is influenza-like ill, test for influenza If you are enrolled in a health plan with a possible or probable diagnosis of influenza, and you meet the criteria listed by the health plan, you will be tested for influenza.
, empiric antifungal therapy should be initiated If you have a proven diagnosis of an IFI, antifungal therapy should be initiated if you have evidence of a fungal infection such as finding fungal elements by cytology or microscopy, or a positive culture for a fungal pathogen.