Anidulafungin Plus Voriconazole Versus Voriconazole For The Treatment Of Invasive Aspergillosis
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| ClinicalTrials.gov Identifier: NCT00531479 |
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Recruitment Status :
Completed
First Posted : September 18, 2007
Results First Posted : April 30, 2012
Last Update Posted : April 30, 2012
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Aspergillosis | Drug: voriconazole Drug: anidulafungin | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 459 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| 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 |
| Study Start Date : | July 2008 |
| Actual Primary Completion Date : | April 2011 |
| Actual Study Completion Date : | May 2011 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Voriconazole
Voriconazole monotherapy
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Drug: 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. Other Name: Vfend |
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Experimental: Voriconazole and Anidulafungin
Combination therapy with voriconazole and anidulafungin
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Drug: 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. Other Name: Eraxis Drug: 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. Other Name: Vfend |
- 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.
- Global Response at Week 6 [ Time Frame: Baseline, Day 42 (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.
- 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) ]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.
- All-cause Mortality at Week 12 in Participants With Probable or Proven Invasive Aspergillosis (IA) [ Time Frame: Day 1 to Day 84 (Week 12) ]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.
- 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) ]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.
- Time to Death: All-Cause Mortality [ Time Frame: Day 1 to Day 84 (Week 12) ]Survival time from start of treatment. Time to death defined as date of death due to any cause minus first treatment date + 1.
- Time to Death Due to Invasive Aspergillosis (IA) [ Time Frame: Day 1 to Day 84 (Week 12) ]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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| Ages Eligible for Study: | 16 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00531479
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| Study Director: | Pfizer CT.gov Call Center | Pfizer |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00531479 History of Changes |
| Other Study ID Numbers: |
A8851009 |
| First Posted: | September 18, 2007 Key Record Dates |
| Results First Posted: | April 30, 2012 |
| Last Update Posted: | April 30, 2012 |
| Last Verified: | April 2012 |
Additional relevant MeSH terms:
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Aspergillosis Mycoses Hyalohyphomycosis Dermatomycoses Lung Diseases, Fungal Skin Diseases, Infectious Skin Diseases Voriconazole Anidulafungin Echinocandins Antifungal Agents |
Anti-Infective Agents 14-alpha Demethylase Inhibitors Cytochrome P-450 Enzyme Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Steroid Synthesis Inhibitors Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Cytochrome P-450 CYP3A Inhibitors |