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Treatment of Aspergillus Fumigatus (a Fungal Infection) in Patients With Cystic Fibrosis

This study has been completed.
Sponsor:
Collaborators:
The Hospital for Sick Children
Canadian Cystic Fibrosis Foundation
The Physicians' Services Incorporated Foundation
Information provided by (Responsible Party):
Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT00528190
First received: September 10, 2007
Last updated: April 3, 2017
Last verified: February 2017
Results First Received: February 1, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Participant, Care Provider, Investigator, Outcomes Assessor;   Primary Purpose: Prevention
Condition: Cystic Fibrosis
Intervention: Drug: Itraconazole

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
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

Participant Flow:   Overall Study
    Itraconazole   Placebo
STARTED   18   17 
COMPLETED   18   16 
NOT COMPLETED   0   1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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
Total Total of all reporting groups

Baseline Measures
   Itraconazole   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 18   17   35 
Age 
[Units: Years]
Mean (Standard Deviation)
     
Participants Analyzed 
[Units: Participants]
 18   17   35 
   25.3  (10.5)   25.2  (9.1)   25.3  (10.5) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 18   17   35 
Female      8  44.4%      8  47.1%      16  45.7% 
Male      10  55.6%      9  52.9%      19  54.3% 
Race and Ethnicity Not Collected [1] 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 0   0   0 
         0 
[1] Race and Ethnicity were not collected from any participant.
Region of Enrollment 
[Units: Participants]
     
Canada       
Participants Analyzed 
[Units: Participants]
 18   17   35 
Canada   18   17   35 


  Outcome Measures

1.  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.   [ Time Frame: 24 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Shawn Aaron
Organization: Ottawa Hospital Research Institute
phone: 613-737-8259
e-mail: saaron@ohri.ca


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT00528190     History of Changes
Other Study ID Numbers: 2006768
Study First Received: September 10, 2007
Results First Received: February 1, 2017
Last Updated: April 3, 2017