Trial Outcomes & Findings for Treatment of Aspergillus Fumigatus (a Fungal Infection) in Patients With Cystic Fibrosis (NCT NCT00528190)
NCT ID: NCT00528190
Last Updated: 2017-05-10
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
35 participants
Primary outcome timeframe
24 weeks
Results posted on
2017-05-10
Participant Flow
Participant milestones
| Measure |
Itraconazole
Itraconazole 5mg/kg/day
Itraconazole: Oral Itraconazole 5mg/kg/day or identical placebo for 24 weeks
|
Placebo
Itraconazole: Oral Itraconazole 5mg/kg/day or identical placebo for 24 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
17
|
|
Overall Study
COMPLETED
|
18
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Itraconazole
n=18 Participants
Itraconazole 5mg/kg/day
Itraconazole: Oral Itraconazole 5mg/kg/day or identical placebo for 24 weeks
|
Placebo
n=17 Participants
Itraconazole: Oral Itraconazole 5mg/kg/day or identical placebo for 24 weeks
|
Total
n=35 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
25.3 years
STANDARD_DEVIATION 10.5 • n=18 Participants
|
25.2 years
STANDARD_DEVIATION 9.1 • n=17 Participants
|
25.3 years
STANDARD_DEVIATION 10.5 • n=35 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=18 Participants
|
8 Participants
n=17 Participants
|
16 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=18 Participants
|
9 Participants
n=17 Participants
|
19 Participants
n=35 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Canada
|
18 participants
n=18 Participants
|
17 participants
n=17 Participants
|
35 participants
n=35 Participants
|
PRIMARY outcome
Timeframe: 24 weeksThe 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.
Outcome measures
| Measure |
Itraconazole
n=18 Participants
Itraconazole 5mg/kg/day
Itraconazole: Oral Itraconazole 5mg/kg/day or identical placebo for 24 weeks
|
Placebo
n=16 Participants
Itraconazole: Oral Itraconazole 5mg/kg/day or identical placebo for 24 weeks
|
|---|---|---|
|
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.
|
4 Participants
|
5 Participants
|
Adverse Events
Itraconazole
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Itraconazole
n=18 participants at risk
Itraconazole 5mg/kg/day
Itraconazole: Oral Itraconazole 5mg/kg/day or identical placebo for 24 weeks
|
Placebo
n=16 participants at risk；n=17 participants at risk
Itraconazole: Oral Itraconazole 5mg/kg/day or identical placebo for 24 weeks
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Spontaneous Pneumothorax
|
5.6%
1/18
|
0.00%
0/17
|
Other adverse events
| Measure |
Itraconazole
n=18 participants at risk
Itraconazole 5mg/kg/day
Itraconazole: Oral Itraconazole 5mg/kg/day or identical placebo for 24 weeks
|
Placebo
n=16 participants at risk；n=17 participants at risk
Itraconazole: Oral Itraconazole 5mg/kg/day or identical placebo for 24 weeks
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Increased Dyspnea
|
11.1%
2/18
|
12.5%
2/16
|
|
Skin and subcutaneous tissue disorders
Rash
|
11.1%
2/18
|
6.2%
1/16
|
|
Gastrointestinal disorders
Hemoptysis
|
11.1%
2/18
|
6.2%
1/16
|
|
Endocrine disorders
Hyperglycemia
|
5.6%
1/18
|
0.00%
0/16
|
|
Gastrointestinal disorders
Flu-like Illness
|
11.1%
2/18
|
0.00%
0/16
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/18
|
6.2%
1/16
|
|
Eye disorders
Conjuctivitis
|
0.00%
0/18
|
6.2%
1/16
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place