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| Name | Class |
|---|---|
| The Hospital for Sick Children | OTHER |
| Canadian Cystic Fibrosis Foundation | OTHER |
| The Physicians' Services Incorporated Foundation | OTHER |
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This clinical trial will attempt to determine whether we can improve clinical outcomes for patients with cystic fibrosis who are infected with a fungus called Aspergillus fumigatus.
The aim of this study is to determine whether antibiotic treatment directed against Aspergillus Fumigatus will be effective at preventing respiratory exacerbations and improving pulmonary function in patients with cystic fibrosis(CF) who are chronically colonized/infected with aspergillus. This aim will be accompanied by means of a randomized, double-blind, placebo-controlled clinical trial incorporating two parallel treatment arms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Itraconazole | Experimental | Itraconazole 5mg/kg/day for 24 weeks |
|
| Placebo | Placebo Comparator | Placebo/day for 24 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Itraconazole | Drug | Oral Itraconazole 5mg/kg/day or identical placebo for 24 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Primary Outcome Measure Will be the Number of Patients Who Experience a Respiratory Exacerbation Requiring Intravenous Antibiotics in the Two Treatment Groups Over the 24 Week Trial Treatment Period. | The Primary outcome measure will be the number of patients who experience a respiratory exacerbation requiring intravenous antibiotics in the two treatment groups over the 24 week trial treatment period. | 24 weeks |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Shawn Aaron, MD | OHRI | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shawn Aaron, The Ottawa Hospital-General Campus | Ottawa | Ontario | K1H 8L6 | Canada | ||
| Felix Ratjen, The Hospital for Sick Children |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22563440 | Derived | Aaron SD, Vandemheen KL, Freitag A, Pedder L, Cameron W, Lavoie A, Paterson N, Wilcox P, Rabin H, Tullis E, Morrison N, Ratjen F. Treatment of Aspergillus fumigatus in patients with cystic fibrosis: a randomized, placebo-controlled pilot study. PLoS One. 2012;7(4):e36077. doi: 10.1371/journal.pone.0036077. Epub 2012 Apr 30. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Itraconazole | Itraconazole 5mg/kg/day Itraconazole: Oral Itraconazole 5mg/kg/day or identical placebo for 24 weeks |
| FG001 | Placebo | Itraconazole: Oral Itraconazole 5mg/kg/day or identical placebo for 24 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Itraconazole | Itraconazole 5mg/kg/day Itraconazole: Oral Itraconazole 5mg/kg/day or identical placebo for 24 weeks |
| BG001 | Placebo | Itraconazole: Oral Itraconazole 5mg/kg/day or identical placebo for 24 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Primary Outcome Measure Will be the Number of Patients Who Experience a Respiratory Exacerbation Requiring Intravenous Antibiotics in the Two Treatment Groups Over the 24 Week Trial Treatment Period. | The Primary outcome measure will be the number of patients who experience a respiratory exacerbation requiring intravenous antibiotics in the two treatment groups over the 24 week trial treatment period. | Posted | Count of Participants | Participants | 24 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Itraconazole | Itraconazole 5mg/kg/day Itraconazole: Oral Itraconazole 5mg/kg/day or identical placebo for 24 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Spontaneous Pneumothorax | Respiratory, thoracic and mediastinal disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Increased Dyspnea | Respiratory, thoracic and mediastinal disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Shawn Aaron | Ottawa Hospital Research Institute | 613-737-8259 | saaron@ohri.ca |
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| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D017964 | Itraconazole |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Toronto |
| Ontario |
| M5G 1X8 |
| Canada |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 1 |
| 18 |
| 2 |
| 18 |
| EG001 | Placebo | Itraconazole: Oral Itraconazole 5mg/kg/day or identical placebo for 24 weeks | 0 | 17 | 2 | 16 |
| Rash | Skin and subcutaneous tissue disorders |
|
| Hemoptysis | Gastrointestinal disorders |
|
| Hyperglycemia | Endocrine disorders |
|
| Flu-like Illness | Gastrointestinal disorders |
|
| Diarrhea | Gastrointestinal disorders |
|
| Conjuctivitis | Eye disorders |
|
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| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
| D010879 |
| Piperazines |