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Effect of Weight and/or Obesity on Sulfamethoxazole and Trimethoprim Concentrations

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: NCT01167452
Recruitment Status : Completed
First Posted : July 22, 2010
Results First Posted : November 2, 2016
Last Update Posted : June 14, 2017
Sponsor:
Collaborators:
National Center for Research Resources (NCRR)
University of Texas Southwestern Medical Center
Information provided by (Responsible Party):
Ron Hall, Texas Tech University Health Sciences Center

Study Description
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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 regardless of the patient's weight. The entire cohort was analyzed for the study outcomes. BMI groups were for recruitment purposes only and were not used for ordinal data analysis.

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 or disease Intervention/treatment Phase
Obesity Pharmacokinetics MRSA Tuberculosis PCP Drug: Sulfamethoxazole/trimethoprim Phase 4

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 infections, urinary tract infections, bronchitis, traveler's diarrhea, Pneumocystis carinii pneumonia, or any other bacterial infection. This is a single center study. A total of 36 adult volunteers will be consented for the study at the Clinical and Translational Research Center (CTRC). Volunteers will be recruited using IRB approved fliers. Volunteers will be admitted to the CTRC for an overnight stay. Half will be female and half male. Twelve volunteers will have a body mass index (BMI) less than 25 kg/m2, twelve will have a BMI 25-40 kg/m2, and twelve will have a BMI greater than 40 kg/m2. Volunteers will have height and weight measured after they have consented to participate. All volunteers will receive a single oral dose of sulfamethoxazole and trimethoprim of 1600 mg/320 mg. The volunteers will have blood drawn via an intravenous catheter just prior to the dose, and then at 1, 2, 4, 8, 12, and 24h after the drug dose. The intravenous catheter is then removed after the 24h blood draw, and the volunteer is discharged from the study.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Population Pharmacokinetic Analysis of Sulfamethoxazole and Trimethoprim in Normal Weight, Overweight, and Obese Volunteers
Study Start Date : July 2010
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Elimination Rate Constants for Sulfamethoxazole and Trimethoprim [ Time Frame: 24 hours ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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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): NCT01167452


Locations
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United States, Texas
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Sponsors and Collaborators
Texas Tech University Health Sciences Center
National Center for Research Resources (NCRR)
University of Texas Southwestern Medical Center
Investigators
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Principal Investigator: Ronald Hall, PharmD, MSCS Texas Tech UHSC
More Information
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Additional Information:

Publications of Results:

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Responsible Party: Ron Hall, Associate Professor, Texas Tech University Health Sciences Center
ClinicalTrials.gov Identifier: NCT01167452    
Other Study ID Numbers: AMA IRB A10-3592
5UL1RR024982-02 ( U.S. NIH Grant/Contract )
First Posted: July 22, 2010    Key Record Dates
Results First Posted: November 2, 2016
Last Update Posted: June 14, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Ron Hall, Texas Tech University Health Sciences Center:
Obesity
Pharmacokinetics
MRSA
Tuberculosis
PCP
Additional relevant MeSH terms:
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Tuberculosis
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
Infections
Trimethoprim
Trimethoprim, Sulfamethoxazole Drug Combination
 Sulfamethoxazole
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Cytochrome P-450 CYP2C8 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Anti-Bacterial Agents