AspergillosisPhase 3NCT00531479

Anidulafungin Plus Voriconazole Versus Voriconazole For The Treatment Of Invasive Aspergillosis

A Phase 3 study testing voriconazole and anidulafungin in people with Aspergillosis, run by Pfizer at 107 sites in 24 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 16 years and older
Conditions the study is for: Aspergillosis
What is being tested?: voriconazole and anidulafungin
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 459 participants
Where: 107 sitesin 24 countries
Study dates: Jul 2008to May 2011
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 16 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Immunocompromised state due to either 1. receipt of hematopoeitic stem cell transplantation or 2. hematologic malignancy;
Diagnosis of possible, probable, or proven invasive aspergillosis.

Who cannot join

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

Trial locations and contacts

107 sites in 24 countries.

Country

City, postcode or hospital

107 sites in 24 countries

United States26 sites

Pfizer Investigational Site
Atlanta, Georgia, 30322
Pfizer Investigational Site
Baltimore, Maryland, 21205
Pfizer Investigational Site
Baltimore, Maryland, 21231-2410
Pfizer Investigational Site
Baltimore, Maryland, 21231
Pfizer Investigational Site
Baltimore, Maryland, 21287
Pfizer Investigational Site
Birmingham, Alabama, 35233
Pfizer Investigational Site
Birmingham, Alabama, 35249
Pfizer Investigational Site
Chapel Hill, North Carolina, 27514
Pfizer Investigational Site
Chicago, Illinois, 60612
Pfizer Investigational Site
Chicago, Illinois, 60637
Pfizer Investigational Site
Detroit, Michigan, 48201
Pfizer Investigational Site
Detroit, Michigan, 48202
Pfizer Investigational Site
Gainesville, Florida, 32610
Pfizer Investigational Site
Houston, Texas, 77030
Pfizer Investigational Site
La Jolla, California, 92037
Pfizer Investigational Site
La Jolla, California, 92093
Pfizer Investigational Site
Little Rock, Arkansas, 72205
Pfizer Investigational Site
Miami, Florida, 33136
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19104
Pfizer Investigational Site
Portland, Oregon, 97239
Pfizer Investigational Site
Rochester, New York, 14642
Pfizer Investigational Site
San Diego, California, 92103-8976
Pfizer Investigational Site
San Francisco, California, 94143
Pfizer Investigational Site
Seattle, Washington, 98109
Pfizer Investigational Site
Seattle, Washington, 98195
Pfizer Investigational Site
Winston-Salem, North Carolina, 27157

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Germany12 sites

Pfizer Investigational Site
Berlin, 10117
Pfizer Investigational Site
Berlin, 12200
Pfizer Investigational Site
Bremen, 28177
Pfizer Investigational Site
Cologne, 50937
Pfizer Investigational Site
Dresden, 01307
Pfizer Investigational Site
Frankfurt (Oder), 15236
Pfizer Investigational Site
Hamburg, 20246
Pfizer Investigational Site
Heidelberg, 69120
Pfizer Investigational Site
Homburg/Saar, 66421
Pfizer Investigational Site
Mainz, 55101
Pfizer Investigational Site
München, 81737
Pfizer Investigational Site
Würzburg, 97080

Other trials in Germany

France8 sites

Pfizer Investigational Site
Brest, 29609
Pfizer Investigational Site
Créteil, 94010
Pfizer Investigational Site
Grenoble, 38043
Pfizer Investigational Site
Marseille, Cedex 09, 13273
Pfizer Investigational Site
Nantes, Cedex 01, 44093
Pfizer Investigational Site
Paris, 75475
Pfizer Investigational Site
Rouen, 76038
Pfizer Investigational Site
Strasbourg, 67098

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Italy7 sites

Pfizer Investigational Site
Cuneo, 12100
Pfizer Investigational Site
Genova, 16132
Pfizer Investigational Site
Milan, 20132
Pfizer Investigational Site
Milan, 20162
Pfizer Investigational Site
Perugia, 06134
Pfizer Investigational Site
Pescara, 65100
Pfizer Investigational Site
Roma, 00168

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Canada6 sites

Pfizer Investigational Site
Hamilton, Ontario, L8N 3Z5
Pfizer Investigational Site
Hamilton, Ontario, L8V 1C3
Pfizer Investigational Site
Montreal, Quebec, H1T 2M4
Pfizer Investigational Site
Québec, Quebec, G1R 2J6
Pfizer Investigational Site
Winnipeg, Manitoba, R3A 1R9
Pfizer Investigational Site
Winnipeg, Manitoba, R3E 0V9

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Spain6 sites

Pfizer Investigational Site
Badalona, Barcelona, 08916
Pfizer Investigational Site
Madrid, Madrid, 28006
Pfizer Investigational Site
Madrid, Madrid, 28050
Pfizer Investigational Site
Salamanca, Salamanca, 37007
Pfizer Investigational Site
Valencia, Valencia, 46010
Pfizer Investigational Site
Valencia, Valencia, 46026

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South Korea5 sites

Pfizer Investigational Site
Seoul, 110-744
Pfizer Investigational Site
Seoul, 120-752
Pfizer Investigational Site
Seoul, 135-710
Pfizer Investigational Site
Seoul, 138-736
Pfizer Investigational Site
Seoul, 150-713

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Belgium4 sites

Pfizer Investigational Site
Bruges, 8000
Pfizer Investigational Site
Brussels, 1000
Pfizer Investigational Site
Leuven, 3000
Pfizer Investigational Site
Yvoir, B-5530

Other trials in Belgium

Russia4 sites

Pfizer Investigational Site
Moscow, 105229
Pfizer Investigational Site
Moscow, 115478
Pfizer Investigational Site
Moscow, 125167
Pfizer Investigational Site
Saint Petersburg, 197089

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Australia3 sites

Pfizer Investigational Site
Adelaide, South Australia, 5000
Pfizer Investigational Site
Herston, Queensland, 4029
Pfizer Investigational Site
Westmead, New South Wales, 2145

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Brazil3 sites

Pfizer Investigational Site
Curitiba, Paraná, 80060-900
Pfizer Investigational Site
Porto Alegre, Rio Grande do Sul, 90020-090
Pfizer Investigational Site
Rio de Janeiro, Rio de Janeiro, 21941-913

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Taiwan3 sites

Pfizer Investigational Site
Kaohsiung City, 807
Pfizer Investigational Site
Kuei-Shan Hsiang, Taoyuan County, 333
Pfizer Investigational Site
Taipei, 112

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Thailand3 sites

Pfizer Investigational Site
Bangkok, Thailand, 10330
Pfizer Investigational Site
Bangkok, 10400
Pfizer Investigational Site
Bangkok, 10700

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Poland2 sites

Pfizer Investigational Site
Gdansk, 80-952
Pfizer Investigational Site
Warsaw, 02-097

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Portugal2 sites

Pfizer Investigational Site
Lisbon, 1169-050
Pfizer Investigational Site
Lisbon, 1649-035

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Singapore2 sites

Pfizer Investigational Site
Singapore, Singapore, 119074
Pfizer Investigational Site
Singapore, Singapore, 169608

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Switzerland2 sites

Pfizer Investigational Site
Geneva, CH-1211
Pfizer Investigational Site
Lausanne, 1011

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Turkey (Türkiye)2 sites

Pfizer Investigational Site
Adana, 01330
Pfizer Investigational Site
Ankara, 06100

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United Kingdom2 sites

Pfizer Investigational Site
London, SE5 9RS
Pfizer Investigational Site
Manchester, M20 4BX

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Czechia1 site

Pfizer Investigational Site
Prague, 128 20

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Greece1 site

Pfizer Investigational Site
Thessaloniki, 57010

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India1 site

Pfizer Investigational Site
Pune, Maharashtra, 411004

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Netherlands1 site

Pfizer Investigational Site
RC Leiden, NL-2300

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Peru1 site

Pfizer Investigational Site
Lima, Lima Province, Lima 34

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About this study

Official 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

Conditions: Aspergillosis
Being tested: voriconazole, anidulafungin
Medical subject headings: Aspergillosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

voriconazoleDrug
Also called Vfend
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.
anidulafunginDrug
Also called Eraxis
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.
voriconazoleDrug
Also called Vfend
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.

Study groups in NCT00531479
Study group	Role	What they receive
Voriconazole	Active comparator	Voriconazole monotherapy Receives: Drug: voriconazole
Voriconazole and Anidulafungin	Experimental	Combination therapy with voriconazole and anidulafungin Receives: Drug: anidulafungin; Drug: voriconazole

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Day 1 to Day 42 (Week 6)

Secondary outcomes (6)

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.
Measured: Baseline, Day 42 (Week 6)
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.
Measured: Day 1 to Day 42 (Week 6)
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.
Measured: Day 1 to Day 84 (Week 12)
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.
Measured: Day 1 to Day 42 (Week 6)
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.
Measured: Day 1 to Day 84 (Week 12)
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.
Measured: Day 1 to Day 84 (Week 12)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2008May 2011

First posted18 Sep 2007 (estimated)
Study startJul 2008
Primary completionApr 2011
Study completionMay 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for AspergillosisStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 459 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00531479
Sponsor's protocol ID: A8851009
Status last verified: Apr 2012
First submitted: 14 Sep 2007
Last updated: 30 Apr 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

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.
PubMed 25599346
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.
PubMed 24914120
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.
PubMed 24913161

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Natural History of Individuals With Immune System Problems That Lead to Fungal Infections
Chronic Mucocutaneous Candidiasis, Invasive Aspergillosis
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Compare Oral Itraconazole and Standard Care Versus Standard Care Alone in Patients With Non-cystic Fibrosis Related Bronchiectasis With Chronic Aspergillus Infection in Reducing Bronchiectasis Exacerbations
Bronchiectasis, Bronchiectasis Adult
Not yet recruitingPhase 3
A Study of Itraconazole and Posaconazole for Chronic Pulmonary Aspergillosis
Chronic Pulmonary Aspergillosis
Not yet recruiting
Real-World Effectiveness of Depemokimab in Allergic Bronchopulmonary Aspergillosis With Severe Eosinophilic Asthma
Allergic Bronchopulmonary Aspergillosis, ABPA
RecruitingPhase 3
A Trial to Compare Nebulized Amphotericin B and Nebulized Normal Saline as Maintenance in Patients With Chronic Pulmonary Aspergillosis
Chronic Pulmonary Aspergillosis, CPA

All Aspergillosis trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official 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
ClinicalTrials.gov ID: NCT00531479
Acronym / sponsor ID: A8851009
Conditions: Aspergillosis
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 459 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Jul 2008
Primary completion: Apr 2011 (actual)
Study completion: May 2011 (actual)
First posted: 18 Sep 2007 (estimated)
Results: Posted 30 Apr 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Voriconazole	Active comparator	Drug: voriconazoleVoriconazole monotherapy
Voriconazole and Anidulafungin	Experimental	Drug: anidulafungin, Drug: voriconazoleCombination therapy with voriconazole and anidulafungin

Who may qualify

Ages: 16 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (2 listed)

Immunocompromised state due to either 1. receipt of hematopoeitic stem cell transplantation or 2. hematologic malignancy;
Diagnosis of possible, probable, or proven invasive aspergillosis.

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
voriconazoleAlso: VfendFirst 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.	Drug	Voriconazole
anidulafunginAlso: EraxisFirst 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.	Drug	Voriconazole and Anidulafungin
voriconazoleAlso: VfendFirst 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.	Drug	Voriconazole and Anidulafungin

Primary outcome

All-cause Mortality at Week 6 in Participants With Proven or Probable Invasive Aspergillosis
Time frame: Day 1 to Day 42 (Week 6)
Number of deaths measured 6 weeks after start of treatment. Time to death defined as date of death minus first treatment date + 1.

6 secondary outcomes

Global Response at Week 6
Time frame: Baseline, Day 42 (Week 6)
All-cause Mortality at Week 6 in Participants With Possible, Probable, or Proven Invasive Aspergillosis (IA)
Time frame: Day 1 to Day 42 (Week 6)
All-cause Mortality at Week 12 in Participants With Probable or Proven Invasive Aspergillosis (IA)
Time frame: Day 1 to Day 84 (Week 12)
Mortality Due to Invasive Aspergillosis (IA) at Week 6 in Participants With Probable or Proven IA
Time frame: Day 1 to Day 42 (Week 6)
Time to Death: All-Cause Mortality
Time frame: Day 1 to Day 84 (Week 12)
Time to Death Due to Invasive Aspergillosis (IA)
Time frame: Day 1 to Day 84 (Week 12)

Results and safety

Results posted to the registry on 30 Apr 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Voriconazole/Anidulafungin	230	154
Voriconazole / Placebo	229	146

Primary outcome: All-cause Mortality at Week 6 in Participants With Proven or Probable Invasive Aspergillosis

Time frame: Day 1 to Day 42 (Week 6). Number. Unit: participants

Measure	Voriconazole/Anidulafungin n = 135	Voriconazole / Placebo n = 142
Value	26	39

Voriconazole/Anidulafungin vs Voriconazole / Placebo: Mean Difference (Final Values): -8.74 (95% CI -18.99 to 1.51), p = 0.0434, Z test for difference in proportions

Population analysed: Modified intent-to-treat (MITT) population: all randomized participants with proven or probable IA confirmed by Day 7 following enrollment who received at least 1 dose of study medication. N=number of participants in MITT population at Week 6. Participants not known to have died were censored at last study visit (Day 84).

6 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Voriconazole/Anidulafungin	115 of 228 (50.4%)	194 of 228 (85.1%)	Not reported
Voriconazole / Placebo	104 of 226 (46%)	192 of 226 (85%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 25599346Marr 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.
Derived from this study: PubMed 24914120Liu 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.
Derived from this study: PubMed 24913161Liu 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.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

Related trials for Aspergillosis

RecruitingObservational study
Natural History of Individuals With Immune System Problems That Lead to Fungal Infections
Chronic Mucocutaneous Candidiasis, Invasive Aspergillosis
RecruitingPhase 3
Compare Oral Itraconazole and Standard Care Versus Standard Care Alone in Patients With Non-cystic Fibrosis Related Bronchiectasis With Chronic Aspergillus Infection in Reducing Bronchiectasis Exacerbations
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A Study of Itraconazole and Posaconazole for Chronic Pulmonary Aspergillosis
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RecruitingPhase 3
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Chronic Pulmonary Aspergillosis, CPA

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

107 sites in 24 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing voriconazole and anidulafungin in people with Aspergillosis, run by Pfizer at 107 sites in 24 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 107 sites in United States, Germany, France, Italy, Canada and 19 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Apr 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All-cause Mortality at Week 6 in Participants With Proven or Probable Invasive Aspergillosis (time frame: Day 1 to Day 42 (Week 6)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00531479, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2012.