Isavuconazole for CPA
Research type
Research Study
Full title
Open label study of the efficacy and safety of isavuconazole for the treatment of Chronic Pulmonary Aspergillosis
IRAS ID
216274
Contact name
Christos Kosmidis
Contact email
Sponsor organisation
University Hospital of South Manchester NHS Foundation Trust
Eudract number
2016-003921-40
Duration of Study in the UK
2 years, 6 months, 0 days
Research summary
Current treatment of Chronic Pulmonary Aspergillosis (CPA) is associated with improvement of symptoms and quality of life but patients experience relapses and treatment side effects. The new antifungal isavuconazole may be at least as safe and effective. Isavuconazole is currently licensed for invasive aspergillosis but not for CPA.
The primary objective of this trial is to determine the efficacy and safety of isavuconazole in CPA and the secondary objectives include understanding the pharmacology and determining rate of resistance development to the drug. Patients with CPA who have not been on treatment will be eligible. Patients will be attending 9 visits (more if clinically needed). Each participant will be treated with isavuconazole (200mg daily) for 52 weeks and followed up for 26 weeks. Participants will be identified from patients attending or referred to the National Aspergillosis Centre (NAC- Wythenshawe Hospital). Eligibility checks will be determined from screening tests or tests done within 3 months of the referral. Informed consent would be sought from all patients and after confirmation of eligibility they would be registered on the trial before treatment started.
Efficacy will be measured from clinical improvement (symptom review, pulmonary function test, weight gain, MRC dyspnoea score, St George’s Respiratory Questionnaire (SGRQ)), laboratory improvement (Aspergillus serology, sputum studies, inflammatory markers) and radiological improvement (chest X-Ray, chest CT scan). Safety will be assessed by documentation of side effects, rate of drug discontinuation/ compliance, laboratory parameters and biochemical studies. Compliance will be assessed by measuring drug levels in blood. Rate of development of resistance will be documented by obtaining sputum samples for fungal culture and susceptibility at each clinic appointment. The results of the study will be compared with data already published elsewhere, and with patients treated previously with standard of care in NAC.REC name
North West - Liverpool Central Research Ethics Committee
REC reference
17/NW/0298
Date of REC Opinion
21 Jul 2017
REC opinion
Further Information Favourable Opinion