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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00531479
Registration number
NCT00531479
Ethics application status
Date submitted
14/09/2007
Date registered
18/09/2007
Date last updated
30/04/2012
Titles & IDs
Public title
Anidulafungin Plus Voriconazole Versus Voriconazole For The Treatment Of Invasive Aspergillosis
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Scientific title
A Prospective, Randomized Trial Comparing The Efficacy Of Anidulafungin And Voriconazole In Combination To That Of Voriconazole Alone When Used For Primary Therapy Of Proven Or Probable Invasive Aspergillosis
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Secondary ID [1]
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A8851009
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
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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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 - voriconazole
Treatment: Drugs - anidulafungin
Treatment: Drugs - voriconazole
Active comparator: Voriconazole - Voriconazole monotherapy
Experimental: Voriconazole and Anidulafungin - Combination therapy with voriconazole and anidulafungin
Treatment: Drugs: voriconazole
First week: Voriconazole 6 mg/kg IV bid for the first 24 hours, followed by 4 mg/kg IV BID plus anidulafungin placebo IV qd.
Second week: Voriconazole 4 mg/kg IV bid or 300 mg PO bid plus anidulafungin placebo IV qd.
Third and fourth weeks: Voriconazole 4 mg/kg IV bid OR 300 mg PO bid plus anidulafungin placebo IV qd,
OR
Voriconazole 4 mg/kg IV bid or 300 mg PO bid monotherapy.
Fifth and sixth weeks: Voriconazole 4 mg/kg IV bid or 300 mg PO bid monotherapy.
Treatment: Drugs: anidulafungin
First week: Voriconazole 6 mg/kg IV bid for the first 24 hours, followed by 4 mg/kg IV bid plus anidulafungin 200 mg IV on day 1, followed by 100 mg IV qd thereafter.
Second week: Voriconazole 4 mg/kg IV bid or 300 mg PO bid plus anidulafungin 100 mg IV qd.
Third and fourth weeks: Voriconazole 4 mg/kg IV bid OR 300 mg PO bid plus anidulafungin 100 mg IV qd,
OR
Voriconazole 4 mg/kg IV bid or 300 mg PO bid monotherapy.
Fifth and sixth weeks: Voriconazole 4 mg/kg IV bid or 300 mg PO bid monotherapy.
Treatment: Drugs: voriconazole
First week: Voriconazole 6 mg/kg IV bid for the first 24 hours, followed by 4 mg/kg IV bid plus anidulafungin 200 mg IV on day 1, followed by 100 mg IV qd thereafter.
Second week: Voriconazole 4 mg/kg IV bid or 300 mg PO bid plus anidulafungin 100 mg IV qd.
Third and fourth weeks: Voriconazole 4 mg/kg IV bid OR 300 mg PO bid plus anidulafungin 100 mg IV qd,
OR
Voriconazole 4 mg/kg IV bid or 300 mg PO bid monotherapy.
Fifth and sixth weeks: Voriconazole 4 mg/kg IV bid or 300 mg PO bid monotherapy.
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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 at Week 6 in Participants With Proven or Probable Invasive Aspergillosis
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Assessment method [1]
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Number of deaths measured 6 weeks after start of treatment. Time to death defined as date of death minus first treatment date + 1.
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Timepoint [1]
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Day 1 to Day 42 (Week 6)
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Secondary outcome [1]
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Global Response at Week 6
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Assessment method [1]
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Number of participants with a successful response (complete or partial global response). Complete response = resolution of all clinical signs and symptoms and \>90% of lesions due to IA that were visible on radiologic studies at baseline (BL); partial response = clinical improvement and \>50% improvement in radiological findings present at BL.
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Timepoint [1]
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Baseline, Day 42 (Week 6)
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Secondary outcome [2]
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All-cause Mortality at Week 6 in Participants With Possible, Probable, or Proven Invasive Aspergillosis (IA)
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Assessment method [2]
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Number of deaths due to any cause measured 6 weeks after start of treatment. Time to death defined as date of death minus first treatment date + 1.
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Timepoint [2]
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Day 1 to Day 42 (Week 6)
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Secondary outcome [3]
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All-cause Mortality at Week 12 in Participants With Probable or Proven Invasive Aspergillosis (IA)
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Assessment method [3]
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Number of deaths due to any cause measured 12 weeks after start of treatment. Time to death defined as date of death minus first treatment date + 1.
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Timepoint [3]
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Day 1 to Day 84 (Week 12)
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Secondary outcome [4]
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Mortality Due to Invasive Aspergillosis (IA) at Week 6 in Participants With Probable or Proven IA
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Assessment method [4]
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Number of deaths due to Invasive Aspergillosis measured 6 weeks after start of treatment. Time to death defined as date of death minus first treatment date + 1.
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Timepoint [4]
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Day 1 to Day 42 (Week 6)
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Secondary outcome [5]
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Time to Death: All-Cause Mortality
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Assessment method [5]
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Survival time from start of treatment. Time to death defined as date of death due to any cause minus first treatment date + 1.
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Timepoint [5]
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Day 1 to Day 84 (Week 12)
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Secondary outcome [6]
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Time to Death Due to Invasive Aspergillosis (IA)
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Assessment method [6]
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Survival time from start of treatment. Time to death defined as date of death due to IA minus first treatment date + 1.
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Timepoint [6]
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Day 1 to Day 84 (Week 12)
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Eligibility
Key inclusion criteria
* Immunocompromised state due to either 1. receipt of hematopoeitic stem cell transplantation or 2. hematologic malignancy;
* Diagnosis of possible, probable, or proven invasive aspergillosis.
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Minimum age
16
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
* Patients with aspergilloma or chronic aspergillosis
* Receipt of 4 or more days of systemic antifungal treatment for the current episode of invasive aspergillosis
* Anticipated survival of less than 5 days or Karnofsky score <=20
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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 receiving the treatment/s
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The people assessing the outcomes
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
Completed
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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
1/07/2008
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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
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Actual
1/05/2011
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Sample size
Target
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Accrual to date
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Final
459
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA
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Recruitment hospital [1]
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Pfizer Investigational Site - Westmead
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Pfizer Investigational Site - Herston
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Pfizer Investigational Site - Adelaide
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2145 - Westmead
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4029 - Herston
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5000 - Adelaide
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Pfizer
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
This study compares the effectiveness and safety of the combination of anidulafungin and voriconazole compared to that of voriconazole alone (which is generally considered the standard of care) for the treatment of Invasive Aspergillosis.
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Trial website
https://clinicaltrials.gov/study/NCT00531479
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Trial related presentations / publications
Marr KA, Schlamm HT, Herbrecht R, Rottinghaus ST, Bow EJ, Cornely OA, Heinz WJ, Jagannatha S, Koh LP, Kontoyiannis DP, Lee DG, Nucci M, Pappas PG, Slavin MA, Queiroz-Telles F, Selleslag D, Walsh TJ, Wingard JR, Maertens JA. Combination antifungal therapy for invasive aspergillosis: a randomized trial. Ann Intern Med. 2015 Jan 20;162(2):81-9. doi: 10.7326/M13-2508. Erratum In: Ann Intern Med. 2015 Mar 17;162(6):463. doi: 10.7326/L15-5068. Ann Intern Med. 2019 Feb 5;170(3):220. doi: 10.7326/L18-0712. Liu P, Mould DR. Population pharmacokinetic-pharmacodynamic analysis of voriconazole and anidulafungin in adult patients with invasive aspergillosis. Antimicrob Agents Chemother. 2014 Aug;58(8):4727-36. doi: 10.1128/AAC.02809-13. Epub 2014 Jun 9. Liu P, Mould DR. Population pharmacokinetic analysis of voriconazole and anidulafungin in adult patients with invasive aspergillosis. Antimicrob Agents Chemother. 2014 Aug;58(8):4718-26. doi: 10.1128/AAC.02808-13. Epub 2014 Jun 9.
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Public notes
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Contacts
Principal investigator
Name
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Pfizer CT.gov Call Center
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Pfizer
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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 are available at
https://clinicaltrials.gov/study/NCT00531479
Download to PDF