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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05101187
Registration number
NCT05101187
Ethics application status
Date submitted
7/09/2021
Date registered
1/11/2021
Date last updated
6/08/2024
Titles & IDs
Public title
Olorofim Aspergillus Infection Study
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Scientific title
Phase III, Adjudicator-blinded, Randomised Study to Evaluate Efficacy and Safety of Treatment With Olorofim Versus Treatment With AmBisome® Followed by Standard of Care in Patients With Invasive Fungal Disease Caused by Aspergillus Species
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Secondary ID [1]
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F901318/0041
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Universal Trial Number (UTN)
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Trial acronym
OASIS
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Invasive Aspergillosis
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Condition category
Condition code
Infection
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Other infectious diseases
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Infection
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0
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Studies of infection and infectious agents
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Olorofim
Treatment: Drugs - AmBisome®
Active comparator: Olorofim - Olorofim versus AmBisome followed by Standard of Care (SOC)
Active comparator: AmBisome - Olorofim versus AmBisome followed by Standard of Care (SOC)
Treatment: Drugs: Olorofim
Loading Dose: 5 tablets (150 mg) to be taken twice daily at a 12-hour (± 1 hour) interval on Day 1 Maintenance Dose: 3 tablets (90 mg) to be taken twice daily at 12-hour (± 1 hour) intervals from Day 2 until Day 84 (± 7 days)
Treatment: Drugs: AmBisome®
Initial course of at least 10 days of AmBisome® administered daily at a dose of 3 mg/kg by IV infusion over a 30- to 60-minute period or according to local guidelines Administration of SOC will follow international, national, or local guidelines and product labelling.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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All-cause mortality
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Assessment method [1]
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To compare all-cause mortality (ACM) at Day 42 following treatment with olorofim versus treatment with AmBisome® followed by standard of care (SOC) in the intent-to-treat (ITT) population of patients with Invasive Fungal Disease (IFD) caused by proven Invasive Aspergillosis (IA) at any site or probable lower respiratory tract disease (LRTD) Aspergillus species (invasive aspergillosis, IA).
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Timepoint [1]
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Treatment Day 42
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Secondary outcome [1]
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Adjudicated Assessment of Overall outcome
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Assessment method [1]
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To compare the effects of treatment with olorofim versus treatment with AmBisome® followed by SOC on Data Review Committee (DRC)-adjudicated assessment of overall outcome in patients with proven IA or probable LRTD IA at Day 42, Day 84, and End of Treatment.
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Timepoint [1]
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Day 42, Day 84, and End of Treatment (anytime during the study between first administration and Day 84)
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Secondary outcome [2]
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Investigator-assessed overall response
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Assessment method [2]
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Investigator-assessed overall response (integrating clinical, radiological, and mycological response).
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Timepoint [2]
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Day 14, Day 28, Day 42, Day 84, EOT (End of Treatment - Maximum Treatment 84 days [± 7 Days]), and 4-week Follow-up (FU).
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Secondary outcome [3]
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To compare the effects of treatment with olorofim versus treatment with AmBisome® followed by SOC on Galactomannan index.
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Assessment method [3]
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The Sponsor's expert advisors suggested that an appropriate rule would be a failure of the GM to decline from baseline. The experts also state that they have seen very significant variation on retesting of both BAL and serum GM samples and believe it is more appropriate to state a fixed reduction of = 1.0 units than any percentage reduction.
These rules are used for changes in GM that document failure of therapy:
1. Serum: After 8 or more days of treatment, serum GM has neither (1) fallen by = 1 unit nor (2) to \< 0.5 based on measurements taken at least 8 days apart.
2. BAL: After 8 or more days of treatment, positive GM from BAL in a patient with a previous BAL test that did not meet the definition of positive (too low or entirely negative) without regard for the interval of time between samples.
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Timepoint [3]
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Day 14, Day 28, Day 42, Day 84, EOT (End of Treatment - Maximum Treatment 84 days [± 7 Days]) and 4-week Follow-up (FU)
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Secondary outcome [4]
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To collect additional olorofim and the disproportionate metabolite H26C pharmacokinetic (PK) data for inclusion in a Population PK model
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Assessment method [4]
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To collect plasma concentration of olorofim and H26C metabolic for for PK analysis (pre-dose and intensive PK). No non-compartmental PK analysis will be performed on the data relating to pre-dose samples and intensive PK samples, apart from data collected from selected regions, which will be reported separately. All relevant olorofim data will be provided to support population PK modelling, which will be reported separately.
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Timepoint [4]
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Day 10, Day 14, Day 21, Day 28, Day 42, Day 56, Day 70, Day 84, and at EOT (End of Treatment - Maximum Treatment 84 days [± 7 Days])
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Secondary outcome [5]
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Data Review Committee's Assessment of Patient Mortality
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Assessment method [5]
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Study data will be independently assessed by a blinded DRC consisting of independent experts in the diagnosis and management of IA, providing an independent adjudication of each patient's mortality based on the survival status collect at time frame.
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Timepoint [5]
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Day 42 and 84 and EOT (End of Treatment - Maximum Treatment 84 days [± 7 Days])
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Secondary outcome [6]
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Diagnosis of a secondary fungal infection
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Assessment method [6]
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To compare incidence of a secondary fungal infection when patients treated with olorofim versus treatment with AmBisome followed by SOC.
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Timepoint [6]
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at any time through End Of Treatment
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Secondary outcome [7]
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Quality of life as measured by the 5 Level 5 Dimension (EQ-5D-5L) at Baseline
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Assessment method [7]
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To assess patient's quality of life measured by the 5-Level 5-Dimension EuroQol Group Health-related Quality of Life Questionnaire (EQ-5D-5L) in both treatment groups
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Timepoint [7]
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Days 14 and EOT (End of Treatment - Maximum Treatment 84 days [± 7 Days])
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Secondary outcome [8]
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Survival status
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Assessment method [8]
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All-cause mortality will be assessed using survival status at time frame.
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Timepoint [8]
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Day 42, Day 84, and End Of Treatment and at the 4 weeks ± 7 days FU
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Secondary outcome [9]
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Safety Assessment
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Assessment method [9]
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To monitor incidence of Adverse Events and Serious Adverse Events in both treatment arms (Olorofim or AmBisome followed by Standard of Care).
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Timepoint [9]
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up to the Day 84 and 4-week Follow-up (FU)
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Eligibility
Key inclusion criteria
1. Male and female patients ages over 18 years and weighing more than 30 kg
2. Patients with proven IA at any site or probable LRTD IA per EORTC/MSG 2019 criteria as adapted for this study and where the duration of specific therapy for this episode of IA has been = 28 days. For purposes of this inclusion, the duration of specific therapy includes any mould-active therapy given for this episode of IA whether subsequently judged potentially effective or not.
3. Patients requiring therapy with an antifungal agent other than a mould-active azole, and who have had = 96 hours of potentially effective prior therapy. Potentially effective prior therapy includes any agent to which the infecting strain of Aspergillus is likely to be susceptible. There are no exclusions or limitations on such agents (eg, AmBisome® is permitted) other than their duration.
4. AmBisome® is an appropriate therapy for the patient.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Women who are pregnant or breastfeeding.
2. Known history of allergy, hypersensitivity, or any serious reaction to any component of the study drug
3. Patients with only chronic aspergillosis, aspergilloma, or allergic bronchopulmonary aspergillosis.
4. Suspected mucormycosis (zygomycosis).
5. Patients with a known active second fungal infection of any type, other than candidiasis that can be treated with fluconazole.
6. The requirement for ongoing use of echinocandin as Candida prophylaxis.
7. Microbiological findings (eg, bacteriological, virological) or other potential conditions that are temporally related and suggest a different aetiology for the clinical features.
8. Human immunodeficiency virus (HIV) infection but not currently receiving antiretroviral therapy.
9. Patients with a baseline prolongation of QT using Fridericia's Correction Formula (QTcF) = 500 msec, or at high risk for QT/QTc prolongation.
10. Evidence of hepatic dysfunction.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
31/03/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/11/2026
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Actual
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Sample size
Target
225
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
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Recruitment hospital [1]
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Royal NorthShore Hospital - Saint Leonards
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Recruitment hospital [2]
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Royal Brisbane & Women's Hospital - Herston
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Recruitment hospital [3]
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The Alfred Hospital - Melbourne
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Recruitment hospital [4]
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Royal Melbourne Hospital - Parkville
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Recruitment hospital [5]
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Fiona Stanley Hospital - Murdoch
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2065 - Saint Leonards
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Recruitment postcode(s) [2]
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4029 - Herston
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Recruitment postcode(s) [3]
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3181 - Melbourne
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Recruitment postcode(s) [4]
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3050 - Parkville
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Recruitment postcode(s) [5]
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6150 - Murdoch
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Recruitment outside Australia
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United States of America
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Alabama
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California
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Florida
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Georgia
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Illinois
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Kansas
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Maryland
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Massachusetts
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Michigan
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North Carolina
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Washington
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Brugge
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Bruxelles
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Gent
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Leuven
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China
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Fuzhou
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China
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Nanning
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Shengyang
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China
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Shijiazhuang
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Xi'an
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Zhengzhou
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France
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Doubs
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Gironde
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France
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France
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France
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Nord
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France
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Paris
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Germany
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Berlin
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Germany
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Koeln
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Israel
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Jerusalem
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Israel
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Ramat Gan
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Israel
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Tel Aviv
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Italy
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Campania
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Italy
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Di Monza E Della Brianza
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Italy
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Genova
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Italy
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Milano
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Italy
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Modena
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Italy
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Perugia
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Italy
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Pisa
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Italy
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Roma
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Japan
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Chiba Ken
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Japan
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Fukuoka Ken
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Japan
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Miyagi Ken
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Japan
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Osaka Fu
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Japan
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Tokyo To
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Japan
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Tokyo
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Bunkyo-Ku
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Nagasaki
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Japan
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Okayama
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Saitama
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Japan
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Shimotsuke
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Korea, Republic of
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Seoul
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Netherlands
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Nijmegen
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Utrecht
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Auckland
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Singapore
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Singapore
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Spain
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Madrid
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Spain
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Barcelona
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Spain
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Valencia
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Kaohsiung
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Taiwan
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New Taipei City
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Taiwan
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Taichung
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Taiwan
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Taipei
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Thailand
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Bangkok
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Thailand
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Khon Kaen
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Turkey
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Ankara
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Turkey
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Diyarbakir
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Turkey
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Istanbul
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Turkey
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Izmir
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Turkey
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Samsun
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United Kingdom
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Wales
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United Kingdom
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London
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
F2G Biotech GmbH
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Address
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Country
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Other collaborator category [1]
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Commercial sector/industry
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Name [1]
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Iqvia Pty Ltd
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Commercial sector/industry
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Shionogi
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Ethics approval
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Summary
Brief summary
The purpose of this study is to compare treatment with olorofim versus treatment with AmBisome® followed by standard of care (SOC) in patients with IFD caused by proven IA or probable lower respiratory tract disease Aspergillus species (invasive aspergillosis, IA).
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Trial website
https://clinicaltrials.gov/study/NCT05101187
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Johan Maertens, MD
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UZ Leuven
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Contact person for public queries
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Daniela Zinzi, MD
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+43 06643582281
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[email protected]
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05101187
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