Trial Outcomes & Findings for Tissue Penetration of Antibiotics in Obesity (NCT NCT00752908)

Results Overview

Cefoxitin plasma concentrations

Recruitment status

COMPLETED

Target enrollment

27 participants

Primary outcome timeframe

8 hours

Results posted on

2019-09-09

Participant Flow

Participant milestones

Participant milestones
Measure	Obese Patients Obese patients	Normal Weight Patients and Volunteers Normal weight patients and volunteers
Overall Study STARTED	14	13
Overall Study COMPLETED	14	13
Overall Study NOT COMPLETED	0	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	Obese Patients n=14 Participants Obese patients	Normal Weight Patients and Volunteers n=13 Participants Normal weight patients and volunteers	Total n=27 Participants Total of all reporting groups
Age, Continuous	52 years STANDARD_DEVIATION 8 • n=14 Participants	28 years STANDARD_DEVIATION 12 • n=13 Participants	40 years STANDARD_DEVIATION 10 • n=27 Participants
Sex: Female, Male Female	12 Participants n=14 Participants	7 Participants n=13 Participants	19 Participants n=27 Participants
Sex: Female, Male Male	2 Participants n=14 Participants	6 Participants n=13 Participants	8 Participants n=27 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	14 Participants n=14 Participants	13 Participants n=13 Participants	27 Participants n=27 Participants

PRIMARY outcome

Timeframe: 8 hours

Cefoxitin plasma concentrations

Outcome measures

Outcome measures
Measure	Obese Patients n=14 Participants Obese patients	Normal Weight Patients and Volunteers n=13 Participants Normal weight patients and volunteers
Cefoxitin Plasma Concentrations	89 (µg/mL) Standard Deviation 20	81 (µg/mL) Standard Deviation 33

SECONDARY outcome

Timeframe: 8 hours

Cefoxitin tissue concentrations

Outcome measures

Outcome measures
Measure	Obese Patients n=10 Participants Obese patients	Normal Weight Patients and Volunteers n=10 Participants Normal weight patients and volunteers
Cefoxitin Tissue Concentrations	8.8 (µg/mL) Standard Deviation 6.6	26 (µg/mL) Standard Deviation 20

Adverse Events

Obese Patients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Normal Weight Patients and Volunteers

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

Evan Kharasch MD PhD

Washington University

Phone: 3143628796

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place