Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

Tissue Penetration of Antibiotics in Obesity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00752908
Recruitment Status : Completed
First Posted : September 16, 2008
Results First Posted : September 9, 2019
Last Update Posted : September 9, 2019
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

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

Condition or disease
Obesity

Layout table for study information
Study Type : Observational
Actual Enrollment : 27 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Tissue Penetration of Antibiotics in Obesity
Study Start Date : February 2008
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Group/Cohort
Obese patients
Obese patients
Normal weight patients and volunteers
Normal weight patients and volunteers



Primary Outcome Measures :
  1. Cefoxitin Plasma Concentrations [ Time Frame: 8 hours ]
    Cefoxitin plasma concentrations


Secondary Outcome Measures :
  1. Cefoxitin Tissue Concentrations [ Time Frame: 8 hours ]
    Cefoxitin tissue concentrations


Biospecimen Retention:   Samples Without DNA
plasma, interstitial fluid


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Surgical Patients at BJH
Criteria

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:

  • Allergy to Cefoxitin
  • Renal or Hepatic insufficiency

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00752908


Locations
Layout table for location information
United States, Missouri
Barnes Jewish Hospital
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Layout table for investigator information
Principal Investigator: Evan D Kharasch, MD, PhD Washington University School of Medicine

Layout table for additonal information
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00752908    
Other Study ID Numbers: 070678
First Posted: September 16, 2008    Key Record Dates
Results First Posted: September 9, 2019
Last Update Posted: September 9, 2019
Last Verified: September 2019
Additional relevant MeSH terms:
Layout table for MeSH terms
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Anti-Bacterial Agents
Anti-Infective Agents