Status:
COMPLETED
Effect of Weight and/or Obesity on Sulfamethoxazole and Trimethoprim Concentrations
Lead Sponsor:
Texas Tech University Health Sciences Center
Collaborating Sponsors:
National Center for Research Resources (NCRR)
University of Texas Southwestern Medical Center
Conditions:
Obesity
Pharmacokinetics
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 regardl...
Detailed Description
This study is designed to measure drug concentrations in the blood of volunteers administered a single oral dose of sulfamethoxazole and trimethoprim. The volunteers to be enrolled will not have ear i...
Eligibility Criteria
Inclusion
- Male and female subjects, age \>18 years, of all racial and ethnic origins.
- We are recruiting 12 normal or underweight (BMI \<25kg/m2), 12 overweight or obese (BMI 25-40 kg/m2), and 12 extremely obese (BMI \> 40 kg/m2) for this study. This index is calculated using the volunteer's height and weight (Formula: weight (lb) / \[height (in)\]2 x 703). Half of each group will be male; the other half will be female.
Exclusion
- Pregnant or nursing or unwilling to use a reliable contraception method during the study. The effects of sulfamethoxazole and trimethoprim on pregnancy are unknown. In addition, the metabolic changes that accompany pregnancy may alter the concentration-time profile of sulfamethoxazole and trimethoprim, so that the pregnancy and post-partum state would be a confounding variable.
- Abnormal liver function tests: transaminases\>10 times upper limit of normal, Alkaline phosphatase\>5 times upper limit of normal, total bilirubin\>5 times upper limit of normal.
- History of allergies to sulfones, sulfonamides or trimethoprim.
- Sulfones, sulfonamides or trimethoprim are contraindicated for any reason.
- Volunteers unwilling to comply with study procedures.
- Current suspected or documented ear infection, urinary tract infection, bronchitis, traveler's diarrhea, Pneumocystis carinii pneumonia, or any other bacterial infection.
- Volunteers with colon resection, gastric bypass, lap band, or any other conditions inhibiting gastric absorption of drug.
- Current or previous participation within 28 days of enrollment in another research study that involves the use of medication, contrast, or any other compound that may alter blood count and/or blood chemistry (liver function, kidney function or electrolyte balance), unless waved by PI.
- Donation of 450mL (one unit) of blood or more within 8 weeks (56 days) prior to study enrollment, unless waved by PI.
- Current use of medications contraindication with sulfamethoxazole/trimethoprim use: Bepridil, Cisapride, Dofetilide, Levomethadyl, Mesoridazine, Pimozide, Terfenadine, and Thioridazine. Other medications will be screened by study investigators to ensure the safety of research participants and maintain the quality of the study.
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT01167452
Start Date
July 1 2010
End Date
May 1 2012
Last Update
June 14 2017
Active Locations (1)
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1
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390