A Study To Evaluate The Safety Of Voriconazole As Treatment Of Invasive Aspergillosis (Fungal Infection) And Other Rare Molds In Children

This study has been terminated.
(This protocol terminated prematurely on July 8, 2013 due to slow enrollment, not because of any safety issues or concerns.)
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00836875
First received: February 3, 2009
Last updated: June 19, 2014
Last verified: June 2014
Results First Received: May 9, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Invasive Aspergillosis
Intervention: Drug: Voriconazole

  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
No text entered.

Reporting Groups
  Description
Voriconazole: 2 to <12 Years Participants aged 2 to less than (<)12 years (and young adolescents aged 12 to 14 years weighing <50 kilograms [kg]) received a loading dose of voriconazole of 9 milligrams per kg (mg/kg), intravenously (IV), every 12 hours (q12h) for the first 24 hours, followed by maintenance dosing of 8 mg/kg IV q12h for a minimum of 7 days of IV therapy. Once significant clinical improvement was observed, participants could have been switched or oral (PO) therapy and received 9 mg/kg PO voriconazole q12h for a maximum dose of 350 mg.
Voriconazole: 12 to <18 Years Participants aged 12 to <18 years (excluding those aged 12-14 years weighing <50 kg) received a loading dose of 6 mg/kg IV q12h for the first 24 hours followed by maintenance dosing of 4 mg/kg IV q12h for a minimum of 7 days of IV therapy. Once significant clinical improvement was observed, participants could have been switched or oral therapy and received 200-300 mg PO q12h.

Participant Flow:   Overall Study
    Voriconazole: 2 to <12 Years     Voriconazole: 12 to <18 Years  
STARTED     11     20  
COMPLETED     8     17  
NOT COMPLETED     3     3  
Death                 3                 2  
Withdrawal by Subject                 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.
Safety population: included all participants who received at least 1 dose of study medication.

Reporting Groups
  Description
Voriconazole: 2 to <12 Years Participants aged 2 to less than (<)12 years (and young adolescents aged 12 to 14 years weighing <50 kilograms [kg]) received a loading dose of voriconazole of 9 milligrams per kg (mg/kg), intravenously (IV), every 12 hours (q12h) for the first 24 hours, followed by maintenance dosing of 8 mg/kg IV q12h for a minimum of 7 days of IV therapy. Once significant clinical improvement was observed, participants could have been switched or oral (PO) therapy and received 9 mg/kg PO voriconazole q12h for a maximum dose of 350 mg.
Voriconazole: 12 to <18 Years Participants aged 12 to <18 years (excluding those aged 12-14 years weighing <50 kg) received a loading dose of 6 mg/kg IV q12h for the first 24 hours followed by maintenance dosing of 4 mg/kg IV q12h for a minimum of 7 days of IV therapy. Once significant clinical improvement was observed, participants could have been switched or oral therapy and received 200-300 mg PO q12h.
Total Total of all reporting groups

Baseline Measures
    Voriconazole: 2 to <12 Years     Voriconazole: 12 to <18 Years     Total  
Number of Participants  
[units: participants]
  11     20     31  
Age  
[units: years]
Mean ± Standard Deviation
  7.9  ± 2.3     14.1  ± 1.7     11.9  ± 3.5  
Gender  
[units: participants]
     
Female     4     11     15  
Male     7     9     16  



  Outcome Measures
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1.  Primary:   Number of Participants With Adverse Events (AEs)   [ Time Frame: Baseline, daily while hospitalized, Days 7, 14, 28, 42, 84, and 114, at end of treatment, and up to 1 month post treatment ]

2.  Secondary:   Percentage of Participants With a Global Response of Success   [ Time Frame: Weeks 6 and End of Treatment (EOT; up to Week 12) ]

3.  Secondary:   All-Cause Mortality - Number of Participant Deaths   [ Time Frame: Week 6 and EOT (up to Week 12) ]

4.  Secondary:   Attributable Mortality - Number of Participant Deaths   [ Time Frame: Weeks 6 and EOT (up to Week 12) ]

5.  Secondary:   Time to Death   [ Time Frame: Baseline up to 1 month post treatment ]


  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
The study was prematurely terminated due to slow enrollment. The study was not terminated due to any safety issues or concerns. Interpretation of the data are limited due to the small sample size and descriptive design.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com


No publications provided


Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00836875     History of Changes
Other Study ID Numbers: A1501080
Study First Received: February 3, 2009
Results First Received: May 9, 2014
Last Updated: June 19, 2014
Health Authority: United States: Food and Drug Administration