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

Primary Purpose

Obesity, Pharmacokinetics, MRSA

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Sulfamethoxazole/trimethoprim

About this trial

This is an interventional treatment trial for Obesity focused on measuring Obesity, Pharmacokinetics, MRSA, Tuberculosis, PCP

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

University of Texas Southwestern Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Sulfamethoxazole/trimethoprim

Arm Description

2 DS tablets of sulfamehtoxazole/trimethoprim (1600 mg/320 mg)

Outcomes

Primary Outcome Measures

Elimination Rate Constants for Sulfamethoxazole and Trimethoprim

Secondary Outcome Measures

Full Information

NCT ID

NCT01167452

First Posted

July 20, 2010

Last Updated

May 17, 2017

Sponsor

Texas Tech University Health Sciences Center

Collaborators

National Center for Research Resources (NCRR), University of Texas Southwestern Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT01167452

Brief Title

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

Official Title

Population Pharmacokinetic Analysis of Sulfamethoxazole and Trimethoprim in Normal Weight, Overweight, and Obese Volunteers

Study Type

Interventional

2. Study Status

Record Verification Date

May 2017

Overall Recruitment Status

Completed

Study Start Date

July 2010 (undefined)

Primary Completion Date

May 2012 (Actual)

Study Completion Date

May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Texas Tech University Health Sciences Center

Collaborators

National Center for Research Resources (NCRR), University of Texas Southwestern Medical Center

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity, Pharmacokinetics, MRSA, Tuberculosis, PCP

Keywords

Obesity, Pharmacokinetics, MRSA, Tuberculosis, PCP

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

36 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Sulfamethoxazole/trimethoprim

Arm Type

Experimental

Arm Description

2 DS tablets of sulfamehtoxazole/trimethoprim (1600 mg/320 mg)

Intervention Type

Drug

Intervention Name(s)

Sulfamethoxazole/trimethoprim

Intervention Description

2 DS tablets of trimethoprim/sulfamethoxazole x 1 dose

Primary Outcome Measure Information:

Title

Elimination Rate Constants for Sulfamethoxazole and Trimethoprim

Time Frame

24 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ronald Hall, PharmD, MSCS

Organizational Affiliation

Texas Tech UHSC

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Texas Southwestern Medical Center

City

Dallas

State/Province

Texas

ZIP/Postal Code

75390

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

27869362

Citation

Hall RG Nd, Pasipanodya JG, Meek C, Leff RD, Swancutt M, Gumbo T. Fractal Geometry-Based Decrease in Trimethoprim-Sulfamethoxazole Concentrations in Overweight and Obese People. CPT Pharmacometrics Syst Pharmacol. 2016 Dec;5(12):674-681. doi: 10.1002/psp4.12146. Epub 2016 Nov 21.

Results Reference

result

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

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