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A Trial Comparing Efficacy and Safety of Voriconazole Administered With Therapeutic Drug Monitoring vs. Standard Dosing (VoriTDM)

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Kieren Marr, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01416025
First received: August 11, 2011
Last updated: July 18, 2016
Last verified: July 2016
Results First Received: April 15, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Fungal Infection
Intervention: Drug: Prospective TDM Arm

  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
Prospective TDM Arm

Voriconazole dose will be adjusted based on per protocol obtained TDM levels

Prospective TDM Arm: Voriconazole dose will be adjusted based on per protocol obtained TDM levels

Standard Dosing Standard doses of voriconazole will be used

Participant Flow:   Overall Study
    Prospective TDM Arm     Standard Dosing  
STARTED     14     15  
COMPLETED     14     15  
NOT COMPLETED     0     0  



  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
Prospective TDM Arm

Voriconazole dose will be adjusted based on per protocol obtained TDM levels

Prospective TDM Arm: Voriconazole dose will be adjusted based on per protocol obtained TDM levels

Standard Dosing Standard doses of voriconazole will be used
Total Total of all reporting groups

Baseline Measures
    Prospective TDM Arm     Standard Dosing     Total  
Number of Participants  
[units: participants]
  14     15     29  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     10     10     20  
>=65 years     4     5     9  
Age  
[units: years]
Mean (Full Range)
  63.4  
  (49 to 83)  
  59.1  
  (28 to 84)  
  62.5  
  (28 to 84)  
Gender  
[units: participants]
     
Female     5     5     10  
Male     9     10     19  
Region of Enrollment  
[units: participants]
     
United States     14     15     29  



  Outcome Measures

1.  Primary:   Number of Participants With Treatment Failure   [ Time Frame: 42 days ]


  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: Dr. Darin Ostrander
Organization: JohnHopkinsU
phone: (443) 287-6217
e-mail: dostrander@jhu.edu



Responsible Party: Kieren Marr, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01416025     History of Changes
Other Study ID Numbers: NA_00041916
Study First Received: August 11, 2011
Results First Received: April 15, 2016
Last Updated: July 18, 2016
Health Authority: United States: Food and Drug Administration