Trial Outcomes & Findings for Pharmacokinetic and Pharmacodynamic Evaluation of Doripenem in Critically Ill Trauma Patients (NCT NCT01027897)

Results Overview

The Volume of distribution is the calculated volume that the given amount of drug is uniformly distributed in the body to achieve a particular concentration

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

30 participants

Primary outcome timeframe

After 3rd dose of study medication

Results posted on

2014-01-27

Participant Flow

Patients recruited from April 2010 to July 2011. All patients were admitted to the Surgical ICU during the study period

Participant milestones

Participant milestones
Measure	Doripenem Group Patients will receive doripenem 1 gm IV over 4 hours X 3 doses for the empiric treatment of an infection
Overall Study STARTED	30
Overall Study COMPLETED	28
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Doripenem Group Patients will receive doripenem 1 gm IV over 4 hours X 3 doses for the empiric treatment of an infection
Overall Study Protocol Violation	1
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Pharmacokinetic and Pharmacodynamic Evaluation of Doripenem in Critically Ill Trauma Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Doripenem Group n=30 Participants Patients will receive doripenem 1 gm IV over 4 hours X 3 doses for the empiric treatment of an infection
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	25 Participants n=99 Participants
Age, Categorical >=65 years	5 Participants n=99 Participants
Age, Continuous	43.6 years STANDARD_DEVIATION 15 • n=99 Participants
Sex: Female, Male Female	6 Participants n=99 Participants
Sex: Female, Male Male	24 Participants n=99 Participants
Region of Enrollment United States	30 participants n=99 Participants

PRIMARY outcome

Timeframe: After 3rd dose of study medication

Population: Patients that completed the study and did not have atypical variations in the measurement of serum concentrations were included in the final evaluation

The Volume of distribution is the calculated volume that the given amount of drug is uniformly distributed in the body to achieve a particular concentration

Outcome measures

Outcome measures
Measure	Doripenem Group n=27 Participants Patients will receive doripenem 1 gm IV over 4 hours X 3 doses for the empiric treatment of an infection
Volume of Distribution (Vd)	28.52 liters Standard Deviation 16.01

PRIMARY outcome

Timeframe: After 3rd dose of study medication

Population: Patients that completed the study and did not have atypical variations in the measurement of serum concentrations were included in the final evaluation

Clearance is the volume of drug removed from the body per unit of time (hrs).

Outcome measures

Outcome measures
Measure	Doripenem Group n=27 Participants Patients will receive doripenem 1 gm IV over 4 hours X 3 doses for the empiric treatment of an infection
Clearance (CL)	16.94 liters per hour Standard Deviation 11.4

PRIMARY outcome

Timeframe: after 3rd dose of study drug

Population: Patients that completed the study and did not have atypical variations in the measurement of serum concentrations were included in the final evaluation

The elimination rate constant of a drug from the central compartment

Outcome measures

Outcome measures
Measure	Doripenem Group n=27 Participants Patients will receive doripenem 1 gm IV over 4 hours X 3 doses for the empiric treatment of an infection
Elimination Constant (ke)	1.47 per hour Standard Deviation 2.24

Adverse Events

Doripenem Group

Serious events: 8 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Doripenem Group n=30 participants at risk Patients will receive doripenem 1 gm IV over 4 hours X 3 doses for the empiric treatment of an infection
Gastrointestinal disorders Lower gastrointestinal	3.3% 1/30 • Number of events 1
Cardiac disorders cardiac arrest	3.3% 1/30 • Number of events 1
Skin and subcutaneous tissue disorders Post operative wound	3.3% 1/30 • Number of events 1
Cardiac disorders atrial fibrillation	6.7% 2/30 • Number of events 2
Vascular disorders deep vein thrombosis	3.3% 1/30 • Number of events 1
Renal and urinary disorders renal failure acute	6.7% 2/30 • Number of events 2

Other adverse events

Adverse event data not reported

Additional Information

Prasad Abraham

Grady Health System

Phone: 404-616-3246

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place