CClinicalTrials.gg
CompletedNCT00752908Updated Sep 9, 2019Results posted

Tissue Penetration of Antibiotics in Obesity

An observational study in Obesity, sponsored by Washington University School of Medicine. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-09-09.

Sponsored by Washington University School of Medicine · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
27
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to evaluate cefoxitin pharmacokinetics in obese surgical patients.

02

Conditions studied

  • Obesity

Browse trials for

03

In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.

This study's enrollment of 27 is below the median of 135 across 1,283 observational studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Washington University School of Medicine is the lead sponsor of 1,765 studies on the registry; 271 are open to participants now.

Of its 324 completed or terminated interventional studies of FDA-regulated products, 212 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Surgical Patients at BJH

Inclusion criteria

  • BMI \<25 and >40
  • Scheduled for elective abdominal or pelvic surgery
  • Surgical plan for intraoperative cefoxitin prophylaxis
  • Able to provide informed consent

Exclusion criteria

Exclusion Criteria:

  • Allergy to Cefoxitin
  • Renal or Hepatic insufficiency
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
27 participants (actual)
Biospecimen retention
Samples without dna

Groups and cohorts

  • Obese patients

    Obese patients

  • Normal weight patients and volunteers

    Normal weight patients and volunteers

06

What researchers measure

Primary outcomes

  1. Cefoxitin Plasma Concentrations

    Cefoxitin plasma concentrations

    Time frame: 8 hours

Secondary outcomes

  1. Cefoxitin Tissue Concentrations

    Cefoxitin tissue concentrations

    Time frame: 8 hours

07

Results

Posted Sep 9, 2019

Participant flow

Participant flow — Overall Study
MilestoneObese PatientsNormal Weight Patients and Volunteers
Started1413
Completed1413
Not completed00

Outcome measures

PrimaryCefoxitin Plasma Concentrations

Cefoxitin plasma concentrations

Time frame:
8 hours
Reported as:
Mean · (µg/mL)
Cefoxitin Plasma Concentrations
(µg/mL)Obese PatientsNormal Weight Patients and Volunteers
Cefoxitin Plasma Concentrations89 ± 2081 ± 33
Statistical analysis
  • Obese Patients vs Normal Weight Patients and Volunteers · t-test, 2 sided · p = <0.05
SecondaryCefoxitin Tissue Concentrations

Cefoxitin tissue concentrations

Time frame:
8 hours
Reported as:
Mean · (µg/mL)
Cefoxitin Tissue Concentrations
(µg/mL)Obese PatientsNormal Weight Patients and Volunteers
Cefoxitin Tissue Concentrations8.8 ± 6.626 ± 20

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Obese Patients0/14 (0%)0/14 (0%)0/14 (0%)
Normal Weight Patients and Volunteers0/13 (0%)0/13 (0%)0/13 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Obese PatientsNormal Weight Patients and VolunteersTotal
Mean52 ± 828 ± 1240 ± 10
Sex: Female, Male
Sex: Female, Male(Participants)Obese PatientsNormal Weight Patients and VolunteersTotal
Female12719
Male268
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Obese PatientsNormal Weight Patients and VolunteersTotal
Count of participants——0
Region of Enrollment
Region of Enrollment(Participants)Obese PatientsNormal Weight Patients and VolunteersTotal
United States141327
08

Study locations

1 site
  • Barnes Jewish Hospital
    Saint Louis, Missouri 63110, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 9, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00752908
Lead sponsor
Washington University School of Medicine
Responsible party
Sponsor
First posted
Sep 16, 2008
Start date
Feb 2008
Primary completion
Jun 2011
Completion
Jun 2011
Results posted
Sep 9, 2019
Last update
Sep 9, 2019

Study contacts

Evan D Kharasch, MD, PhD
principal investigator · Washington University School of Medicine

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion