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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
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
Timepoint [1] 0 0
Day 1 to Day 42 (Week 6)
Secondary outcome [1] 0 0
Global Response at Week 6
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)
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)
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
Timepoint [4] 0 0
Day 1 to Day 42 (Week 6)
Secondary outcome [5] 0 0
Time to Death: All-Cause Mortality
Timepoint [5] 0 0
Day 1 to Day 84 (Week 12)
Secondary outcome [6] 0 0
Time to Death Due to Invasive Aspergillosis (IA)
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
Sex
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
1/07/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2011
Sample size
Target
Accrual to date
Final
459
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
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United States of America
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Florida
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United States of America
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Georgia
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United States of America
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Illinois
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United States of America
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Maryland
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United States of America
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Michigan
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New York
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North Carolina
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Oregon
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Pennsylvania
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Texas
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United States of America
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Washington
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Belgium
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Brugge
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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
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PR
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Brazil
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RJ
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Brazil
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RS
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Canada
State/province [22] 0 0
Manitoba
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Canada
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Ontario
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Canada
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Quebec
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Czech Republic
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Praha 2
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France
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Cedex 01
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France
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France
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Brest
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France
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Creteil
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France
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GRENOBLE Cedex 09
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France
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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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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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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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Barcelona
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Madrid
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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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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
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London
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United Kingdom
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Manchester

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

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