AspergillosisPhase 4NCT00620074

Study to Test the Combination of Voriconazole and Anidulafungin in Patients Who Have, or Are Thought to Have, Invasive Aspergillosis and Who Are Unable to Take a Common Antifungal Therapy (Polyene)

A Phase 4 study testing voriconazole and anidulafungin in people with Aspergillosis, run by Pfizer at 4 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

This study will test the effectiveness and the safety of giving two antifungal agents (voriconazole and anidulafungin) together to treat invasive aspergillosis in patients who are unable to tolerate polyene therapy. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Aspergillosis
What is being tested?: voriconazole and anidulafungin
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 6 participants
Where: 4 sitesUnited States
Study dates: Aug 2008to Feb 2009
Phase: Phase 4
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Proven or probable invasive aspergillosis. Patient is intolerant to polyene therapy.

Who cannot join

Patients with invasive aspergillosis for more than 30 days at the time of study entry. Patients with uncontrolled bacterial or viral infection at the time of study entry. Patients with significant liver dysfunction or who are taking certain medications which interact with voriconazole.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Pfizer Investigational Site
Atlanta, Georgia, 30322
Pfizer Investigational Site
Detroit, Michigan, 48202
Pfizer Investigational Site
Fort Worth, Texas, 76104
Pfizer Investigational Site
Fort Worth, Texas, 76107

Other trials in United States

About this study

Official title: Phase IV Open-Label Pilot Study to Evaluate the Combination of Voriconazole and Anidulafungin for the Treatment of Subjects With Proven or Probable Invasive Aspergillosis Who Are Intolerant of Polyene Treatment

Read the detailed description

The study was terminated on January 12, 2009 due to the overall low rate of enrollment. The decision to terminate the trial was not based on any safety concerns. Patients who were enrolled in the study prior to January 12, 2009 were allowed to remain in the study until completing their participation as specified in the protocol.

Conditions: Aspergillosis
Being tested: voriconazole, anidulafungin
Keywords: invasive aspergillosis, opportunistic mold infection
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
Subjects with creatinine clearance at least 50 ml/min will receive initial treatment with IV (loading dose of 6 mg/kg Q12h followed by maintenance dose of 4 mg/kg Q12h) or oral (loading dose of 400 mg Q12h followed by maintenance dose of 300 mg Q12h). Subjects with creatinine clearance <50 ml/min will receive oral voriconazole (loading dose of 400 mg Q12h followed by maintenance dose of 300 mg Q12h).
anidulafunginDrug
Also called Eraxis
Loading dose of 200 mg QD followed by maintenance dose of 100 mg QD for up to a total of 28 days therapy

Study groups in NCT00620074
Study group	Role	What they receive
combination 2	Experimental	anidulafungin plus voriconazole Receives: Drug: voriconazole
combination 1	Experimental	anidulafungin plus voriconazole Receives: Drug: anidulafungin

What is being measured

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

Summary of Global Response at End of Treatment (EOT)
Number of subjects with global response consisting of a combination of clinical and radiological findings at the end of therapy. Possible outcome categories: Complete Response: resolution of all clinical signs and symptoms and more than 90% of lesions due to invasive aspergillosis that were visible on radiological studies; Partial Response: clinical improvement and greater than 50% improvement in radiological findings; Stable Response: no change from baseline or an improvement of less than 50% in radiological findings; Failure (no response): worsening disease.
Measured: End of Treatment (Day 42)

Secondary outcomes (4)

Summary of Global Response at Week 2, Week 4, and Week 6
Number of subjects with global response consisting of a combination of clinical and radiological findings at the end of therapy. Possible outcome categories: Complete Response: resolution of all clinical signs and symptoms and more than 90% of lesions due to invasive aspergillosis that were visible on radiological studies; Partial Response: clinical improvement and greater than 50% improvement in radiological findings; Stable Response: no change from baseline or an improvement of less than 50% in radiological findings; Failure (no response): worsening disease.
Measured: Week 2, Week 4, Week 6
Summary of Mortality
Number of subects with documented mortality (death).
Measured: Up to Week 6
Galactomannan Titer Assay Levels and Global Response
Number of subjects per Galactomannan titer level with global response for all subjects (with or without renal impairment). The galactomann assay is an immunological blood serum test used to diagnose invasive aspergillosis and to monitor disease progression. Global response is a composite of clinical and radiological findings summarized as Complete Response: resolution of all clinical signs and symptoms; Partial Response: clinical improvement; Stable Response: no change from baseline or an improvement of less than 50% in radiological findings; Failure (no response): worsening disease.
Measured: Up to Week 6
Voriconazole Trough Levels With Intravenous and Oral Dosing
Voriconazole trough plasma concentrations measured as nanograms per milliliter (ng/mL).
Measured: Week 1 through Week 6

Timeline

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

Aug 2008Feb 2009

First posted21 Feb 2008 (estimated)
Study startAug 2008
Primary completionFeb 2009
Study completionFeb 2009

Why it stopped: See Detailed Description

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.
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 4
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 6 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00620074
Sponsor's protocol ID: A8851014
Status last verified: Jan 2010
First submitted: 8 Feb 2008
Last updated: 15 Feb 2010
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

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

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
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 15 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase IV Open-Label Pilot Study to Evaluate the Combination of Voriconazole and Anidulafungin for the Treatment of Subjects With Proven or Probable Invasive Aspergillosis Who Are Intolerant of Polyene Treatment
ClinicalTrials.gov ID: NCT00620074
Acronym / sponsor ID: A8851014
Conditions: Aspergillosis
Keywords: invasive aspergillosis, opportunistic mold infection
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: See Detailed Description
Enrolment: 6 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Aug 2008
Primary completion: Feb 2009 (actual)
Study completion: Feb 2009 (actual)
First posted: 21 Feb 2008 (estimated)
Results: Posted 15 Feb 2010

Clinical summary

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
combination 2	Experimental	Drug: voriconazoleanidulafungin plus voriconazole
combination 1	Experimental	Drug: anidulafunginanidulafungin plus voriconazole

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Proven or probable invasive aspergillosis. Patient is intolerant to polyene therapy.

Key exclusion criteria (1 listed)

Patients with invasive aspergillosis for more than 30 days at the time of study entry. Patients with uncontrolled bacterial or viral infection at the time of study entry. Patients with significant liver dysfunction or who are taking certain medications which interact with voriconazole.

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: VfendSubjects with creatinine clearance at least 50 ml/min will receive initial treatment with IV (loading dose of 6 mg/kg Q12h followed by maintenance dose of 4 mg/kg Q12h) or oral (loading dose of 400 mg Q12h followed by maintenance dose of 300 mg Q12h). Subjects with creatinine clearance <50 ml/min will receive oral voriconazole (loading dose of 400 mg Q12h followed by maintenance dose of 300 mg Q12h).	Drug	combination 2
anidulafunginAlso: EraxisLoading dose of 200 mg QD followed by maintenance dose of 100 mg QD for up to a total of 28 days therapy	Drug	combination 1

Primary outcome

Summary of Global Response at End of Treatment (EOT)
Time frame: End of Treatment (Day 42)
Number of subjects with global response consisting of a combination of clinical and radiological findings at the end of therapy. Possible outcome categories: Complete Response: resolution of all clinical signs and symptoms and more than 90% of lesions due to invasive aspergillosis that were visible on radiological studies; Partial Response: clinical improvement and greater than 50% improvement in radiological findings; Stable Response: no change from baseline or an improvement of less than 50% in radiological findings; Failure (no response): worsening disease.

4 secondary outcomes

Summary of Global Response at Week 2, Week 4, and Week 6
Time frame: Week 2, Week 4, Week 6
Summary of Mortality
Time frame: Up to Week 6
Galactomannan Titer Assay Levels and Global Response
Time frame: Up to Week 6
Voriconazole Trough Levels With Intravenous and Oral Dosing
Time frame: Week 1 through Week 6

Results and safety

Results posted to the registry on 15 Feb 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Anidulalfungin and Voriconazole	6	5

Primary outcome: Summary of Global Response at End of Treatment (EOT)

Time frame: End of Treatment (Day 42). Number. Unit: participants

Measure	Anidulalfungin and Voriconazole n = 6
Failure (No response)	1
Partial response	3
Stable response	0
Complete response	2

Population analysed: Intent-to-treat (ITT): includes all subjects who received at least 1 dose of study medication. No descriptive or inferential analysis was completed due to low enrollment and subsequent early termination of study.

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Anidulalfungin and Voriconazole	4 of 6 (66.7%)	6 of 6 (100%)	Not reported

Limitations and caveats (from the sponsor): Due to low enrollment and early termination of the study, data was insufficient for descriptive or inferential analysis as planned; no significant treatment-related safety results were identified in the subjects treated with combination therapy.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2010.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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
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

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

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing voriconazole and anidulafungin in people with Aspergillosis, run by Pfizer at 4 sites in United States.

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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 15 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 15 Feb 2010). 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?

Summary of Global Response at End of Treatment (EOT) (time frame: End of Treatment (Day 42)). 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 NCT00620074.

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 15 Feb 2010.