Posaconazole (MK-5592) IV and oral in children (less than 2 years) with IFI
Research type
Research Study
Full title
A Phase 2, Open-Label, Single-Arm, Sequential-Panel Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Posaconazole (POS, MK-5592) Intravenous and Powder for Oral Suspension Formulations in Pediatric Participants From Birth to Less Than 2 Years of Age With Possible, Probable, or Proven Invasive Fungal Infection
IRAS ID
1004668
Contact name
- -
Contact email
Sponsor organisation
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc
Eudract number
2019-003842-34
Clinicaltrials.gov Identifier
Research summary
Invasive Fungal Infections (IFI) are serious infections caused by fungi (e.g. mould or yeast). IFI infections can affect important organs like the lungs & may spread through the blood. IFI are rare but can be life threatening for people with weak immune systems. IFI represent a major cause of morbidity and mortality in paediatric haematology–oncology. Progress has been achieved in treatment, but mortality remains as high as 20%.
Posaconazole (POS) has been approved for use in adults and children age 13 and older to prevent and treat IFI. POS is available by prescription as an intravenous (IV) solution, a delayed-release tablet, and an oral suspension (liquid form).
•The IV solution, which is given through a needle in a vein, is approved for use in adults age 18 and older.
•The delayed-release tablet and oral suspension (both given orally), are approved for use in adults and children aged over 13yrs.
This study tests the IV solution and powder for oral suspension (PFS) forms of POS. The PFS form of POS has the same ingredients as the delayed release tablet, but in liquid form that can be given to younger children. This study aims to;
•Test the safety of POS in children less than 2 years old
•See how the body handles POS
•See if taking POS can help children with IFI survive
•See if children who take POS also need other medicines for their IFI
•Measure what happens when IV POS and oral PFS POS go through the body.
This study is open label and interventional (both the patient’s family and doctor will know the allocated treatment). About 40 children will participate. Children in Panel A will be in this trial for about 4 weeks and will visit the trial site about 5 times. Children in Panel B will be in the trial for up to 16 weeks and will visit the trial site about 12 times. The study will run for approximately 2.5 years.
The study is sponsored by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. (“MSD”), and will open at 2 sites in the UK.REC name
South Central - Berkshire Research Ethics Committee
REC reference
22/SC/0106
Date of REC Opinion
4 Aug 2022
REC opinion
Further Information Unfavourable Opinion