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Tissue Penetration of Antibiotics in Obesity
This study has been completed.

First Received on September 12, 2008.   Last Updated on June 27, 2011   History of Changes
Sponsor: Washington University School of Medicine
Information provided by: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00752908
  Purpose

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


Condition
Obesity

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Tissue Penetration of Antibiotics in Obesity

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • plasma and tissue cefoxitin concentrations at the time of incision [ Time Frame: 8 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • cefoxitin pharmacokinetic parameters [ Time Frame: 8 hours ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

plasma, interstitial fluid


Estimated Enrollment: 30
Study Start Date: February 2008
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
2

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00752908

Locations
United States, Missouri
Barnes Jewish Hospital
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Evan D Kharasch, MD, PhD Washington University School of Medicine
  More Information

No publications provided

Responsible Party: Evan Kharasch, MD, PhD, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00752908     History of Changes
Other Study ID Numbers: 070678
Study First Received: September 12, 2008
Last Updated: June 27, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012