A Multicenter, Prospective, Randomized, Double-Blind Clinical Trial Comparing Itraconazole Oral Solution in Cyclodextrin to Placebo in the Treatment of Aspergilloma
NCT00005668 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 96
Last updated 2010-08-27
Summary
To compare the safety and effectiveness of itraconazole oral solution to placebo in the treatment of a pulmonary aspergilloma.
Aspergilloma is a "fungal ball" in the lungs caused by Aspergillus. The infection can spread from the lungs through the blood to other organs. Aspergilloma can be life-threatening; therefore, an effective treatment is needed.
Conditions
- Aspergillosis
- Lung Diseases, Fungal
Interventions
- DRUG
-
Itraconazole oral solution
Sponsors & Collaborators
-
National Institute of Allergy and Infectious Diseases (NIAID)
lead NIH
Study Design
- Purpose
- TREATMENT
- Masking
- DOUBLE
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Completion
- 2005-11-30
Countries
- United States
Study Locations
More Related Trials
-
A Study to Evaluate the Effect of Multiple Doses of Isavuconazole on the Pharmacokinetics of a Single Dose of Prednisone in Healthy Adult Subjects
NCT01711827 ·Status: COMPLETED ·Phase: PHASE1
-
An Efficacy and Safety Study of Itraconazole Sequential Therapy (Intravenous Injection Followed by Oral Solution) in Invasive Pulmonary Fungal Infections
NCT01823289 ·Status: COMPLETED ·Phase: PHASE4
-
A Trial to Compare Nebulized Amphotericin B and Nebulized Normal Saline as Maintenance in Patients With Chronic Pulmonary Aspergillosis
NCT06447402 ·Status: RECRUITING ·Phase: PHASE3
-
Single Ascending Oral Dose Study of F901318
NCT02394483 ·Status: COMPLETED ·Phase: PHASE1
-
A Randomized, Open, Comparative Multicenter Study of Initial Treatment With Intravenous Itraconazole Versus Amphotericin B Followed by Consolidation Treatment With Itraconazole Capsules in Patients With Blastomycosis or Histoplasmosis
NCT00002159 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy Of Itraconazole In Chronic Cavitary Pulmonary Aspergillosis
NCT01259336 ·Status: COMPLETED ·Phase: PHASE4
-
Treatment of Aspergillus Fumigatus (a Fungal Infection) in Patients With Cystic Fibrosis
NCT00528190 ·Status: COMPLETED ·Phase: PHASE4
-
A Study to Learn About How Itraconazole Affects the Blood Level of Study Medicine (PF-07817883) in Healthy Adults.
NCT05822440 ·Status: COMPLETED ·Phase: PHASE1
-
Trial of Micafungin (FK463) in Combination With Liposomal Amphotericin B (AmBisome) for Aspergillosis
NCT00047827 ·Status: TERMINATED ·Phase: PHASE2
-
Isavuconazole (BAL8557) for Primary Treatment of Invasive Aspergillosis
NCT00412893 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy of Intrabronchial Voriconazole Instillation for Inoperable Pulmonary Aspergilloma
NCT03799809 ·Status: UNKNOWN ·Phase: PHASE2/PHASE3
-
A Study To Assess The Anidulafungin And Voriconazole Concentration In Lung Following Intravenous Administration In Healthy Subjects
NCT00940017 ·Status: COMPLETED ·Phase: PHASE4
-
An Open-label, Two-period, Fixed-sequence Study to Evaluate Multiple-dose Itraconazole Effect on The Single-dose PK of PF-06372865 in Healthy Subjects
NCT02475746 ·Status: WITHDRAWN ·Phase: PHASE1
-
Comparative Study of Micafungin (FK463) Versus Placebo as Prophylactic Antifungal Therapy in the ICU
NCT00048750 ·Status: TERMINATED ·Phase: PHASE3
-
A Randomized Controlled Trial to Compare the Clinical Outcomes With Six Months of Therapy With Oral Itraconazole Versus Oral Voriconazole for Management of Treatment naïve Subjects With Chronic Pulmonary Aspergillosis
NCT04824417 ·Status: COMPLETED ·Phase: PHASE3
-
MK0991 in Combination With Standard Antifungal Agent(s) for the Treatment of Salvage Invasive Aspergillosis (0991-037)
NCT00076869 ·Status: COMPLETED ·Phase: PHASE2
-
Study to Evaluate the Pharmacokinetics of 14C-labeled Isavuconazole Following a Single Oral Dose of 14C-labeled Prodrug Isavuconazonium Sulfate (BAL8557) in Healthy Male Subjects
NCT01813461 ·Status: COMPLETED ·Phase: PHASE1
-
Posaconazole as Salvage Therapy for Aspergillus Pulmonary Infection.
NCT02020213 ·Status: WITHDRAWN ·Phase: PHASE4
-
Phase II Study of Fluconazole for Lymphocutaneous and Visceral Sporotrichosis
NCT00004938 ·Status: COMPLETED ·Phase: PHASE2
-
Post Marketing Study to Evaluate the Efficacy and Safety of Micafungin Treatment on Invasive Aspergillosis
NCT02646774 ·Status: TERMINATED ·Phase: PHASE4
-
Six Months Versus 12 Months of Oral Itraconazole Therapy for Management of Treatment naïve Subjects With CPA
NCT03920527 ·Status: COMPLETED ·Phase: PHASE3
-
Post Marketing Study to Evaluate the Safety and Efficacy of Micafungin Against Fungal Infections Caused by Candida Spp or Aspergillus Spp
NCT02646800 ·Status: TERMINATED ·Phase: PHASE4
-
Caspofungin Study for Fungal Infections in Adults in Critical Care Settings
NCT00095316 ·Status: TERMINATED ·Phase: PHASE3
-
F901318 Single Ascending Dose Study in Healthy Male Volunteers
NCT02142153 ·Status: COMPLETED ·Phase: PHASE1
-
Micafungin Salvage Mono-therapy in Invasive Aspergillosis
NCT00376337 ·Status: TERMINATED ·Phase: PHASE2