AmBiVor
Research type
Research Study
Full title
A Multi-country, Non-interventional, Retrospective Drug Utilization Study in Haematological Malignancy Patients Treated for Probable or Proven Invasive Aspergillosis
IRAS ID
326753
Contact name
Varun Mehra
Contact email
Sponsor organisation
Gilead Sciences Europe Ltd
Duration of Study in the UK
0 years, 5 months, 2 days
Research summary
Opportunistic fungal infections are a major cause of disease and death in patients with blood cancers, with invasive aspergillosis (IA) being a particular problem in these patients despite the use of mould-active preventative treatments.
International clinical guidelines recommend voriconazole and isavuconazole as the first-line treatment for IA, with AmBisome (which is a lipid formulation of amphotericin B) recommended as an alternative. However, there is a lack of real world data in the targeted treatment setting. This study will therefore generate evidence associated with the use of AmBisome and voriconazole in IA-treated patients, looking at effectiveness and adverse events of special interests.
This retrospective chart review study will use existing patient medical record data collected from approximately 16 hospitals in five European countries. High-risk patients with blood cancers (including acute myeloid leukaemia, myelodysplastic syndromes, acute lymphoblastic leukaemia and patients who have undergone haematopoietic stem cell transplantation) with a diagnosis of documented probable or proven IA, who initiated treatment of AmBisome or voriconazole between 01 January 2014 and 31 December 2019 will be included in the study. Approximately 200 patients will be included in each arm (AmBisome or voriconazole).
This study will not influence patient treatment, as it does not require any intervention and does not interfere with standard medical care. There will be no additional samples, visits, diagnostic or monitoring procedures required in the study.
Clinical data will be collected from the start of AmBisome or voriconazole treatment (baseline), until the end of the follow-up period (defined as death, lost to follow-up or 84 (± 7 days) days after the start of primary therapy, whichever came earliest.
The study will last approximately 5 months.
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
23/WM/0144
Date of REC Opinion
20 Jun 2023
REC opinion
Favourable Opinion