Trial Outcomes & Findings for Single Dose Population Pharmacokinetics of Intravenous Posaconazole in Critically Ill Patients (NCT NCT02968134)

Last Updated: 2018-09-21

Results Overview

The primary outcome is plasma posaconazole exposure expressed as the area under the total plasma concentration-time curve from time zero to infinity resulting from a single dose of 300 mg of posaconazole administered intravenously.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

8 participants

Primary outcome timeframe

48 hours

Results posted on

2018-09-21

Participant Flow

Participant milestones

Participant milestones
Measure	Posaconazole The study will enrol eight patients with presumed or confirmed systemic fungal infections, who are admitted to ICU Posaconazole: A single dose of 300mg intravenous posaconazole will be administered and blood samples will be taken prior to start of infusion, at 15,45,75minutes, 3,5,8,12,18,24,30,36 and 48 hours.
Overall Study STARTED	8
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Posaconazole n=8 Participants The study will enrol eight patients with presumed or confirmed systemic fungal infections, who are admitted to ICU Posaconazole: A single dose of 300mg intravenous posaconazole will be administered and blood samples will be taken prior to start of infusion, at 15,45,75minutes, 3,5,8,12,18,24,30,36 and 48 hours.
Age, Categorical <=18 years	0 Participants n=8 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=8 Participants
Age, Categorical >=65 years	0 Participants n=8 Participants
Sex: Female, Male Female	1 Participants n=8 Participants
Sex: Female, Male Male	7 Participants n=8 Participants
BMI	22.6 kg/m^2 n=8 Participants
Acute Physiology and Chronic Health Evaluation II Score	17 units on a scale n=8 Participants
Serum creatinine	106 umol/L n=8 Participants
Urinary creatinine clearance	74 mL/min n=8 Participants
Serum albumin	20 g/L n=8 Participants
ALT	53 IU/mL n=8 Participants
AST	47 IU/mL n=8 Participants
ALP	75 IU/mL n=8 Participants
Total bilirubin	11 umol/L n=8 Participants
INR	1.3 ratio n=8 Participants

PRIMARY outcome

Timeframe: 48 hours

Outcome measures

Outcome measures
Measure	Posaconazole n=8 Participants The study will enrol eight patients with presumed or confirmed systemic fungal infections, who are admitted to ICU Posaconazole: A single dose of 300mg intravenous posaconazole will be administered and blood samples will be taken prior to start of infusion, at 15,45,75minutes, 3,5,8,12,18,24,30,36 and 48 hours.
Posaconazole Exposure Described as Area Under the Total Plasma Concentration-time Curve From Time Zero to Infinity After a Single Dose	17932 ng*h/mL Interval 13823.0 to 27905.0

PRIMARY outcome

Timeframe: 48 hours

This is a measure of free posaconazole ( not bound to plasma proteins) exposure in the plasma. This is an important measure of exposure because its the free concentration that distributes into targets sites of infection to produce clinical effect.

Outcome measures

Outcome measures
Measure	Posaconazole n=8 Participants The study will enrol eight patients with presumed or confirmed systemic fungal infections, who are admitted to ICU Posaconazole: A single dose of 300mg intravenous posaconazole will be administered and blood samples will be taken prior to start of infusion, at 15,45,75minutes, 3,5,8,12,18,24,30,36 and 48 hours.
Posaconazole Exposure Expressed as Area Under the Unbound Concentrations-time Curve From Time Zero to Infinity	97.2 ng*h/mL Interval 72.8 to 134.8

Adverse Events

Posaconazole

Serious events: 1 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Posaconazole n=8 participants at risk The study will enrol eight patients with presumed or confirmed systemic fungal infections, who are admitted to ICU Posaconazole: A single dose of 300mg intravenous posaconazole will be administered and blood samples will be taken prior to start of infusion, at 15,45,75minutes, 3,5,8,12,18,24,30,36 and 48 hours.
Gastrointestinal disorders Death	12.5% 1/8 • Number of events 1 • Adverse event data were collected over one and half year of patient enrolment.

Other adverse events

Adverse event data not reported

Additional Information

Prof. Jason Roberts

The University of Queensland

Phone: +61 7 3646 4108

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60