Effect of Weight and/or Obesity on Sulfamethoxazole and Trimethoprim Concentrations
This study will find how weight affects the dosing of a drug called sulfamethoxazole and trimethoprim. Currently, the amount of sulfamethoxazole and trimethoprim a patient receives is the same regardless of the patient's weight.
All sulfamethoxazole and trimethoprim (Trade name is Bactrim or Septra) medication that you will receive in this study will be referred to as study medication within this informed consent form. This drug is a combination of two antibiotics, sulfamethoxazole and trimethoprim, which belongs to a class of medication known as "sulfones" and is approved by the US Food and Drug Administration (FDA) for the treatment of a wide variety of bacterial infections such as ear infections, urinary tract infections, bronchitis, traveler's diarrhea, and Pneumocystis carinii pneumonia. Sulfamethoxazole and trimethoprim is given orally.
|Study Design:||Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Population Pharmacokinetic Analysis of Sulfamethoxazole and Trimethoprim in Normal Weight, Overweight, and Obese Volunteers|
- Serum clearance [ Time Frame: 24 hours ] [ Designated as safety issue: No ]Blood draws will be conducted over 24 hours to determine the serum clearance of trimethoprim and sulfamethoxazole.
|Study Start Date:||July 2010|
|Study Completion Date:||May 2012|
|Primary Completion Date:||May 2012 (Final data collection date for primary outcome measure)|
2 DS tablets of sulfamehtoxazole/trimethoprim (1600 mg/320 mg)
2 DS tablets of trimethoprim/sulfamethoxazole x 1 dose
|United States, Texas|
|University of Texas Southwestern Medical Center|
|Dallas, Texas, United States, 75390|
|Principal Investigator:||Ronald Hall, PharmD, MSCS||Texas Tech UHSC|