Posaconazole versus Voraconazole for Invasive Aspergillosis Treatment
Research type
Research Study
Full title
A Phase 3 Randomized Study of the Efficacy and Safety of Posaconazole versus Voriconazole for the Treatment of Invasive Aspergillosis in Adults (Phase 3; Protocol No. MK-5592-069)
IRAS ID
122576
Contact name
Achyut Guleri
Contact email
Sponsor organisation
MSD
Eudract number
2011-003938-14
Clinicaltrials.gov Identifier
Research summary
Aspergillosis is a fungus which occurs everywhere and produces microscopically small spores that float in the air. Normally, when aspergillus spores are inhaled, the immune system recognises the spores as foreign and destroys them. Occasionally, in an individual with a weakened immune system or a pre-existing medical condition the aspergillus spores can grow inside a lung or a wound. This is known as invasive aspergillosis (IA).
Current guidelines recommend the use of an antifungal drug called voriconazole (VOR) as the primary treatment for IA. It is recommended that antifungal treatment is started while the diagnosis of IA is still being evaluated. VOR is a type of antifungal drug called an azole and the length of treatment with azoles is not yet well defined. Based on previous clinical studies it is currently recommended that the minimum treatment for patients with a weak immune system is between 6 and 12 weeks.
Posaconazole (POS) is a highly active azole which is currently approved as Noxafil® oral suspension for the treatment of IA. POS may have some potential advantages in terms of tolerability, drug interactions and safety.
This study will investigate POS and VOR in patients with proven or probable IA. Patients with possible IA may also be enrolled into the study with further evaluation of proven or probable IA. Patients will be enrolled into the study randomly in a 1:1 ratio to receive either POS or VOR.
The study will assess the effect of POS on IA and compare it to the effect of VOR on IA. This study will also assess the safety of POS in two new formulations, intravenous (IV) and oral tablet form. Most patients will begin on IV therapy and move to oral; however, some patients may start the study receiving oral therapy. In addition, the study will also look at how the POS is absorbed and broken down in the body.
REC name
North West - Haydock Research Ethics Committee
REC reference
14/NW/0269
Date of REC Opinion
15 Jul 2014
REC opinion
Further Information Favourable Opinion