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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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
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
Secondary ID [1] 0 0
A8851009
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Aspergillosis 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
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.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
All-cause Mortality at Week 6 in Participants With Proven or Probable Invasive Aspergillosis - Number of deaths measured 6 weeks after start of treatment. Time to death defined as date of death minus first treatment date + 1.
Timepoint [1] 0 0
Day 1 to Day 42 (Week 6)
Secondary outcome [1] 0 0
Global Response at Week 6 - 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.
Timepoint [1] 0 0
Baseline, Day 42 (Week 6)
Secondary outcome [2] 0 0
All-cause Mortality at Week 6 in Participants With Possible, Probable, or Proven Invasive Aspergillosis (IA) - 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.
Timepoint [2] 0 0
Day 1 to Day 42 (Week 6)
Secondary outcome [3] 0 0
All-cause Mortality at Week 12 in Participants With Probable or Proven Invasive Aspergillosis (IA) - 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.
Timepoint [3] 0 0
Day 1 to Day 84 (Week 12)
Secondary outcome [4] 0 0
Mortality Due to Invasive Aspergillosis (IA) at Week 6 in Participants With Probable or Proven IA - 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.
Timepoint [4] 0 0
Day 1 to Day 42 (Week 6)
Secondary outcome [5] 0 0
Time to Death: All-Cause Mortality - Survival time from start of treatment. Time to death defined as date of death due to any cause minus first treatment date + 1.
Timepoint [5] 0 0
Day 1 to Day 84 (Week 12)
Secondary outcome [6] 0 0
Time to Death Due to Invasive Aspergillosis (IA) - Survival time from start of treatment. Time to death defined as date of death due to IA minus first treatment date + 1.
Timepoint [6] 0 0
Day 1 to Day 84 (Week 12)

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.
Minimum age
16 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA
Recruitment hospital [1] 0 0
Pfizer Investigational Site - Westmead
Recruitment hospital [2] 0 0
Pfizer Investigational Site - Herston
Recruitment hospital [3] 0 0
Pfizer Investigational Site - Adelaide
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment postcode(s) [2] 0 0
4029 - Herston
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
State/province [2] 0 0
Arkansas
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United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
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United States of America
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Maryland
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United States of America
State/province [8] 0 0
Michigan
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United States of America
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New York
Country [10] 0 0
United States of America
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North Carolina
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Oregon
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United States of America
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Pennsylvania
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United States of America
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Texas
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United States of America
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Washington
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Belgium
State/province [15] 0 0
Brugge
Country [16] 0 0
Belgium
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Bruxelles
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Belgium
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Leuven
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Belgium
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Yvoir
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Brazil
State/province [19] 0 0
PR
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Brazil
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RJ
Country [21] 0 0
Brazil
State/province [21] 0 0
RS
Country [22] 0 0
Canada
State/province [22] 0 0
Manitoba
Country [23] 0 0
Canada
State/province [23] 0 0
Ontario
Country [24] 0 0
Canada
State/province [24] 0 0
Quebec
Country [25] 0 0
Czech Republic
State/province [25] 0 0
Praha 2
Country [26] 0 0
France
State/province [26] 0 0
Cedex 01
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France
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Cedex 09
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France
State/province [28] 0 0
Brest
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France
State/province [29] 0 0
Creteil
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France
State/province [30] 0 0
GRENOBLE Cedex 09
Country [31] 0 0
France
State/province [31] 0 0
Paris
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France
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Rouen Cedex
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France
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Strasbourg
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Germany
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Berlin
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Germany
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Bremen
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Germany
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Dresden
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Germany
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Frankfurt (Oder)
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Germany
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Hamburg
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Germany
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Heidelberg
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Germany
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Homburg/Saar
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Germany
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Koeln
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Germany
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Mainz
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Germany
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Muenchen
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Germany
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Wuerzburg
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Greece
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Thessaloniki
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India
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Maharashtra
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Italy
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Cuneo
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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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Perugia
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Italy
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Pescara
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Italy
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Roma
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Korea, Republic of
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Seoul
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Netherlands
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RC Leiden
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Peru
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Lima
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Poland
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Gdansk
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Poland
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Warszawa
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Portugal
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Lisboa
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Russian Federation
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Moscow
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Russian Federation
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Saint Petersburg
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Singapore
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Singapore
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Salamanca
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Spain
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Valencia
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Switzerland
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Geneve 14
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Switzerland
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Lausanne
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Taiwan
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Taoyuan County
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Taiwan
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Kaohsiung
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Taiwan
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Taipei
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Thailand
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Bangkok
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Turkey
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Adana
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Turkey
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Ankara
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United Kingdom
State/province [74] 0 0
London
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United Kingdom
State/province [75] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT00531479
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications