Trial Outcomes & Findings for A Trial Comparing Efficacy and Safety of Voriconazole Administered With Therapeutic Drug Monitoring vs. Standard Dosing (NCT NCT01416025)

NCT ID: NCT01416025

Last Updated: 2016-08-18

Results Overview

The primary endpoint of the study will be a binary outcome, called Failure, defined as one of the following: measured at 42 days from initiation of drug administration: 1. Progression of underlying infection (clinical failure) 2. Death 3. Development of a voriconazole-associated SAE: LFTs, Rash, Visual disturbance, Neurologic abnormality (e.g: hallucinations)

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 29 participants
• Primary outcome timeframe: 42 days
• Results posted on: 2016-08-18

Participant Flow

Participant milestones

Measure	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
Overall Study STARTED	14	15
Overall Study COMPLETED	14	15
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Prospective TDM Arm n=14 Participants 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 n=15 Participants Standard doses of voriconazole will be used	Total n=29 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Age, Continuous	63.4 years n=5 Participants	59.1 years n=7 Participants	62.5 years n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	10 Participants n=7 Participants	19 Participants n=5 Participants
Region of Enrollment United States	14 participants n=5 Participants	15 participants n=7 Participants	29 participants n=5 Participants

PRIMARY outcome

Timeframe: 42 days

The primary endpoint of the study will be a binary outcome, called Failure, defined as one of the following: measured at 42 days from initiation of drug administration:

1. Progression of underlying infection (clinical failure)

2. Death

3. Development of a voriconazole-associated SAE: LFTs, Rash, Visual disturbance, Neurologic abnormality (e.g: hallucinations)

Outcome measures

Measure	Prospective TDM Arm n=14 Participants 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 n=15 Participants Standard doses of voriconazole will be used
Number of Participants With Treatment Failure	1 participants	5 participants

Adverse Events

Prospective TDM Arm

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Standard Dosing

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Measure	Prospective TDM Arm n=14 participants at risk 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 n=15 participants at risk Standard doses of voriconazole will be used
Respiratory, thoracic and mediastinal disorders hospitalization	0.00% 0/14	6.7% 1/15 • Number of events 1

Other adverse events

Measure	Prospective TDM Arm n=14 participants at risk 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 n=15 participants at risk Standard doses of voriconazole will be used
Psychiatric disorders Stop voriconazole	21.4% 3/14 • Number of events 3	26.7% 4/15 • Number of events 4

Additional Information

Dr. Darin Ostrander

JohnHopkinsU

Phone: (443) 287-6217

Email: dostrander@jhu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place