Trial Outcomes & Findings for Pharmacokinetics of Ceftolozane/Tazobactam in Plasma and Cerebrospinal Fluid (NCT NCT03309657)

Results Overview

Unbound Ceftolozane Exposure in the plasma given by the area under the unbound concentration-time curve from time zero to infinity (AUC0-inf).

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

10 participants

Primary outcome timeframe

Samples collected from 0 to 8 hours post dose at "0, 1, 2,4,6, & 8 h post dose were use estimate area under the curve from time zero to infinity estimated by non-compartmental analysis

Results posted on

2020-09-10

Participant Flow

Participant milestones

Participant milestones
Measure	Ceftolozane Tazobactam Infected patients with external intraventricular drain will receive a single dose of Ceftolozane/ tazobactam (3000mg) over 1 hour and will undergo blood , csf and urine sampling at specific times over an 8 hour period. Ceftolozane/tazobactam: IV ceftolozane 2000mg /tazobactam 1000mg once only
Overall Study STARTED	10
Overall Study COMPLETED	10
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	Ceftolozane Tazobactam n=10 Participants Infected patients with external intraventricular drain will receive a single dose of Ceftolozane/ tazobactam (3000mg) over 1 hour and will undergo blood , csf and urine sampling at specific times over an 8 hour period. Ceftolozane/tazobactam: IV ceftolozane 2000mg /tazobactam 1000mg once only
Age, Continuous	60.5 years n=10 Participants
Sex: Female, Male Female	7 Participants n=10 Participants
Sex: Female, Male Male	3 Participants n=10 Participants
Region of Enrollment Australia	10 participants n=10 Participants
Weight	75 kg n=10 Participants
Serum Creatinine	48.5 micro-mole/litre n=10 Participants
Albumin	24 g/L n=10 Participants
Acute Physiology and Chronic Health Evaluation (APACHE) II	17.5 units on a scale n=10 Participants

PRIMARY outcome

Timeframe: Samples collected from 0 to 8 hours post dose at "0, 1, 2,4,6, & 8 h post dose were use estimate area under the curve from time zero to infinity estimated by non-compartmental analysis

Unbound Ceftolozane Exposure in the plasma given by the area under the unbound concentration-time curve from time zero to infinity (AUC0-inf).

Outcome measures

Outcome measures
Measure	Ceftolozane Tazobactam n=10 Participants Infected patients with external intraventricular drain will receive a single dose of Ceftolozane/ tazobactam (3000mg) over 1 hour and will undergo blood , csf and urine sampling at specific times over an 8 hour period. Ceftolozane/tazobactam: IV ceftolozane 2000mg /tazobactam 1000mg once only
Unbound Ceftolozane Exposure in the Plasma	322.6 mg*h/L Interval 182.7 to 413.9

PRIMARY outcome

Timeframe: Samples collected from 0 to 8 hours post dose at "0, 1, 2,4,6, & 8 h post dose were use estimate area under the curve from time zero to infinity estimated by non-compartmental analysis

Unbound Tazobactam Exposure in the plasma given by the area under the unbound concentration-time curve from time zero to infinity (AUC0-inf).

Outcome measures

Outcome measures
Measure	Ceftolozane Tazobactam n=10 Participants Infected patients with external intraventricular drain will receive a single dose of Ceftolozane/ tazobactam (3000mg) over 1 hour and will undergo blood , csf and urine sampling at specific times over an 8 hour period. Ceftolozane/tazobactam: IV ceftolozane 2000mg /tazobactam 1000mg once only
Unbound Tazobactam Exposure in the Plasma	52.1 mg*h/L Interval 35.7 to 79.6

PRIMARY outcome

Timeframe: Samples collected from 0 to 8 hours post dose at "0, 1, 2,4,6, & 8 h post dose were use estimate area under the curve from time zero to infinity estimated by non-compartmental analysis

Unbound Ceftolozane Exposure in the CSF given by the area under the unbound concentration-time curve from time zero to infinity (AUC0-inf).

Outcome measures

Outcome measures
Measure	Ceftolozane Tazobactam n=10 Participants Infected patients with external intraventricular drain will receive a single dose of Ceftolozane/ tazobactam (3000mg) over 1 hour and will undergo blood , csf and urine sampling at specific times over an 8 hour period. Ceftolozane/tazobactam: IV ceftolozane 2000mg /tazobactam 1000mg once only
Unbound Ceftolozane Exposure in the CSF	30.2 mg*h/L Interval 18.8 to 128.3

PRIMARY outcome

Timeframe: Samples collected from 0 to 8 hours post dose at "0, 1, 2,4,6, & 8 h post dose were use estimate area under the curve from time zero to infinity estimated by non-compartmental analysis

Unbound Tazobactam Exposure in the CSF given by the area under the unbound concentration-time curve from time zero to infinity (AUC0-inf).

Outcome measures

Outcome measures
Measure	Ceftolozane Tazobactam n=10 Participants Infected patients with external intraventricular drain will receive a single dose of Ceftolozane/ tazobactam (3000mg) over 1 hour and will undergo blood , csf and urine sampling at specific times over an 8 hour period. Ceftolozane/tazobactam: IV ceftolozane 2000mg /tazobactam 1000mg once only
Unbound Tazobactam Exposure in the CSF	5.6 mg*h/L Interval 1.6 to 24.4

Adverse Events

Ceftolozane Tazobactam

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Prof. Jason Roberts

University of Queensland Center for Clinical Research

Phone: +61 7 334 65032

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place