Trial Outcomes & Findings for Levofloxacin Pharmacokinetics (PK) in the Severely Obese (NCT NCT00176306)

Results Overview

A peripheral intravenous catheter will be placed in each arm for drug administration and serial blood sampling. Pre-existing intravenous access will be utilized when possible. Subjects will rest in a supine position while receiving a 750 mg intravenous dose of levofloxacin over 90 minutes. Serial blood samples will be obtained 1.5, 3, 4, 5, 8, 12, and 24 hours after the beginning of administration of levofloxacin. Data will be presented as mean area under the curve +/- standard deviation.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

15 participants

Primary outcome timeframe

24 hours

Results posted on

2018-06-06

Participant Flow

Participant milestones

Participant milestones
Measure	Levofloxacin Arm Patients receive commercially available levofloxacin 750mg solution for intravnous use
Overall Study STARTED	15
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Levofloxacin Pharmacokinetics (PK) in the Severely Obese

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Levofloxacin Arm n=15 Participants patients receiving levofloxacin
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=99 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants
Age, Continuous	38.4 years STANDARD_DEVIATION 12.8 • n=99 Participants
Sex: Female, Male Female	7 Participants n=99 Participants
Sex: Female, Male Male	8 Participants n=99 Participants
Region of Enrollment United States	15 participants n=99 Participants

PRIMARY outcome

Timeframe: 24 hours

Population: pilot study

A peripheral intravenous catheter will be placed in each arm for drug administration and serial blood sampling. Pre-existing intravenous access will be utilized when possible. Subjects will rest in a supine position while receiving a 750 mg intravenous dose of levofloxacin over 90 minutes. Serial blood samples will be obtained 1.5, 3, 4, 5, 8, 12, and 24 hours after the beginning of administration of levofloxacin. Data will be presented as mean area under the curve +/- standard deviation.

Outcome measures

Outcome measures
Measure	Levofloxacin Arm n=15 Participants Subjects receiving levofloxacin
Plasma Concentration of Levofloxacin	76 mg/L*hr Standard Deviation 32

Adverse Events

Levofloxacin Arm

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

Aaron Cook

University of Kentucky

Phone: 8593239258

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place