9766-CL-0107:Isavuconazonium Sulfate for IA and IM in paediatrics
Research type
Research Study
Full title
A Phase 2, Open-Label, Non-Comparative, Multicenter Study to Evaluate the Safety and Tolerability,Efficacy and Pharmacokinetics of Isavuconazonium Sulfate for the Treatment of Invasive Aspergillosis (IA) or Invasive Mucormycosis (IM) in Pediatric Subjects
IRAS ID
263454
Contact name
Robert Phillips
Contact email
Sponsor organisation
Astellas Pharma Global Development, Inc.
Eudract number
2018-003975-36
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 3 months, 2 days
Research summary
This study is looking at how safe and effective isavuconazonium sulfate is in paediatric patients. It will also look at how well they can tolerate this drug dose while they are being treated for either of the following fungal infections; invasive aspergillosis (IA) or invasive mucormycosis (IM).
Fungal infections remain an important cause of morbidity and mortality in paediatric patients. In paediatric patients with an impaired immune system they have a higher chance of picking up hospital acquired invasive mould infections like IA and IM and they are the leading cause of mortality in this population. Isavuconazonium sulfate is a new azole antifungal agent that was approved for use in adults for the treatment of invasive aspergillosis (IA) and invasive mucormycosis (IM) in the US and in Europe for treatment of IA; and for the treatment of IM in patients for whom amphotericin B is inappropriate.There are currently very limited approved treatment options for paediatric patients. Therefore,establishing an efficacious and safe dosage regimen for isavuconazole for use in paediatric patients will provide important information for physicians treating these patients.
Approximately 30 centres in the US and EU are planned to enrol approximately 30 patients ages 1 to < 18 years of age. These patients will be recruited at their attending hospital and will have a positive diagnosis with IA or IM. All patients will receive isavuconazonium sulfate via a needle into the vein. Treatment will begin on day 1 and will be administered daily until the patient has a successful outcome or for a maximum duration of 84 days (IA) or 180 days (IM),whichever occurs first. Throughout the study, safety and tolerability will be assessed by the recording of Adverse Events,vital signs, ECGs and safety laboratory evaluations.
REC name
East of England - Cambridge South Research Ethics Committee
REC reference
19/EE/0299
Date of REC Opinion
26 Nov 2019
REC opinion
Further Information Favourable Opinion