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

NCT01167452 | Completed Phase 4 Results

• 2 other identifiers: AMA IRB A10-35925UL1RR024982-02
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Pharmacokinetics; MRSA; Tuberculosis; PCP

Keywords

Obesity; Pharmacokinetics; MRSA; Tuberculosis; PCP

Outcome Measures

Primary Outcomes (1)

• Elimination Rate Constants for Sulfamethoxazole and Trimethoprim

  24 hours

Study Arms (1)

Sulfamethoxazole/trimethoprim

EXPERIMENTAL

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

Drug: Sulfamethoxazole/trimethoprim

Interventions

Sulfamethoxazole/trimethoprim DRUG

2 DS tablets of trimethoprim/sulfamethoxazole x 1 dose

Sulfamethoxazole/trimethoprim

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Texas Tech University Health Sciences Center: lead
• National Center for Research Resources (NCRR): collaborator
• University of Texas Southwestern Medical Center: collaborator

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Related Publications (1)

• 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.

  PMID: 27869362 RESULT

Related Links

• Link to manuscript describing our findings

MeSH Terms

Conditions

Obesity; Tuberculosis

Interventions

Trimethoprim, Sulfamethoxazole Drug Combination

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Sulfamethoxazole; Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Sulfanilamides; Aniline Compounds; Amines; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Trimethoprim; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Results Point of Contact

• Title: Ronald Hall, PharmD, MSCS
• Organization: Texas Tech University Health Sciences Center

ronald.hall@ttuhsc.edu

214-358-9009

Study Officials

• Ronald Hall, PharmD, MSCS

  Texas Tech UHSC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 20, 2010
• First Posted: July 22, 2010
• Study Start: July 1, 2010
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: June 14, 2017
• Results First Posted: November 2, 2016

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)