Trial Outcomes & Findings for Concentration of Ertapenem in Colorectal Tissue (NCT NCT00535652)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

23 participants

Primary outcome timeframe

3 to 6 hours after a single dose of 1 gram ertapenem I.V..

Results posted on

2017-02-10

Participant Flow

Participant milestones

Participant milestones
Measure	Ertapenem Administration of 1 gram ertapenem I.V. Ertapenem: powder for infusion, 1 gram I.V., single dose over 30 min.
Overall Study STARTED	23
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Concentration of Ertapenem in Colorectal Tissue

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ertapenem n=23 Participants Administration of 1 gram ertapenem I.V. Ertapenem: powder for infusion, 1 gram I.V., single dose over 30 min.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	19 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants
Age, Continuous	55 years n=5 Participants
Gender Female	4 Participants n=5 Participants
Gender Male	19 Participants n=5 Participants
Region of Enrollment Germany	23 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 to 6 hours after a single dose of 1 gram ertapenem I.V..

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: The mean (+- SD) tissuetotal concentrations of ertapenem in the colorectal tissue as an average of every 30 miuntes up to 10 hours

The mean (+- SD) tissuetotal concentrations of ertapenem in the colorectal tissue every 30 minutes up to 10 hours

Outcome measures

Outcome measures
Measure	Ertapenem n=20 Participants Administration of 1 gram ertapenem I.V. Ertapenem: powder for infusion, 1 gram I.V., single dose over 30 min.
Tissue (Total) Concentrations of Ertapenem in the Colorectal Tissue	6.4 mg/kg Standard Deviation 2.3

SECONDARY outcome

Timeframe: 0 to approx. 14 days after admission

Outcome measures

Outcome data not reported

Adverse Events

Ertapenem

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Ertapenem n=20 participants at risk Administration of 1 gram ertapenem I.V. Ertapenem: powder for infusion, 1 gram I.V., single dose over 30 min.
Renal and urinary disorders Urinary tract infection	20.0% 4/20

Additional Information

Prof. Dr. Henne-Bruns, PI

University of Ulm

Phone: ++4973150053500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place