Effect of Weight and/or Obesity on Sulfamethoxazole and Trimethoprim Concentrations
This study has been completed.
Sponsor:
Texas Tech University Health Sciences Center
Collaborators:
University of Texas Southwestern Medical Center
Information provided by (Responsible Party):
Ron Hall, Texas Tech University Health Sciences Center
ClinicalTrials.gov Identifier:
NCT01167452
First received: July 20, 2010
Last updated: December 13, 2012
Last verified: December 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Obesity Pharmacokinetics MRSA Tuberculosis PCP |
Drug: Sulfamethoxazole/trimethoprim |
Phase 4 |
| Study Type: | Interventional |
| 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 |
Resource links provided by NLM:
Further study details as provided by Texas Tech University Health Sciences Center:
Primary Outcome Measures:
- 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.
| Enrollment: | 36 |
| Study Start Date: | July 2010 |
| Study Completion Date: | May 2012 |
| Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Sulfamethoxazole/trimethoprim
2 DS tablets of sulfamehtoxazole/trimethoprim (1600 mg/320 mg)
|
Drug: Sulfamethoxazole/trimethoprim
2 DS tablets of trimethoprim/sulfamethoxazole x 1 dose
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01167452
Locations
| United States, Texas | |
| University of Texas Southwestern Medical Center | |
| Dallas, Texas, United States, 75390 | |
Sponsors and Collaborators
Texas Tech University Health Sciences Center
University of Texas Southwestern Medical Center
Investigators
| Principal Investigator: | Ronald Hall, PharmD, MSCS | Texas Tech UHSC |
More Information
No publications provided
| Responsible Party: | Ron Hall, Associate Professor, Texas Tech University Health Sciences Center |
| ClinicalTrials.gov Identifier: | NCT01167452 History of Changes |
| Other Study ID Numbers: | AMA IRB A10-3592, 5UL1RR024982-02 |
| Study First Received: | July 20, 2010 |
| Last Updated: | December 13, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Texas Tech University Health Sciences Center:
|
Obesity Pharmacokinetics MRSA Tuberculosis PCP |
Additional relevant MeSH terms:
|
Obesity Tuberculosis Overnutrition Nutrition Disorders Overweight Body Weight Signs and Symptoms Mycobacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections Sulfamethoxazole Trimethoprim |
Trimethoprim-Sulfamethoxazole Combination Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Anti-Infective Agents, Urinary Renal Agents Antimalarials Antiprotozoal Agents Antiparasitic Agents Folic Acid Antagonists Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 19, 2013