Posaconazole (MK-5592) Intravenous and Oral in Children (<2 Years) With Invasive Fungal Infection (MK-5592-127)

  • STATUS
    Recruiting
  • End date
    Jul 31, 2023
  • participants needed
    40
  • sponsor
    Merck Sharp & Dohme Corp.
Updated on 27 October 2021
Investigator
Toll Free Number
Primary Contact
Instituto Nacional de Enfermedades Neoplasicas ( Site 1601) (2.5 mi away) Contact
+12 other location

Summary

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).

Description

There are 2 panels in this study. In Panel A, POS IV will be evaluated in 8 participants, including 5 who are <3 months of age and 3 who are 3 months to <2 years of age. In Panel B, both POS IV and POS PFS will be evaluated in 14 participants, including 3 who are <3 months of age and 5 who transition to the PFS formulation of POS.

Details
Condition Mycoses, Systemic Fungal Infections, Invasive Fungal Infection, Invasive Fungal Infections, Fungal Infections
Treatment Posaconazole IV 6 mg/kg, Posaconazole IV TBD, Posaconazole PFS TBD
Clinical Study IdentifierNCT04665037
SponsorMerck Sharp & Dohme Corp.
Last Modified on27 October 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Panel A: Is undergoing treatment for possible, probable, or proven IFI known or suspected to be cause by fungal pathogens against which POS has demonstrated activity (which can include candidiasis)
Panel B: has a diagnosis of possible, probable, or proven IFI known or suspected to be cause by fungal pathogens against which POS has demonstrated activity (and cannot include candidiasis)
If enrolled with a possible or probable IFI diagnosis, has one or more of the listed host factors
If enrolled with a possible or probable IFI diagnosis, meets listed criteria
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
Has clinical symptoms consistent with an acute episode of IFI, defined as duration of clinical syndrome of <30 days
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
Has a body weight of 500 g
The participant (or legally acceptable representative) has provided documented informed consent for the study

Exclusion Criteria

Has received POS within 30 days before Day 1
Has cystic fibrosis, pulmonary sarcoidosis, aspergilloma, or allergic bronchopulmonary aspergillosis
Has a known hereditary problem of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
Has known or suspected active COVID-19 infection
Has chronic (30 days' duration) IFI, relapsed/recurrent IFI, or refractory IFI that has not responded to prior antifungal treatment
Has a known hypersensitivity or other serious adverse reaction to any azole antifungal therapy, or to any other ingredient of the study intervention used
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
Has received any listed prohibited medications within the specified timeframes before the start of study intervention
Has a known hereditary problem of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption (Part B)
Has enrolled previously in the current study and been discontinued
Has invasive candidiasis (Part B)
Is hemodynamically unstable, exhibits hemodynamic compromise, or is not expected to survive at least 5 days
Has QTc prolongation at screening >500 msec
Has significant liver dysfunction
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note