Phase 4 N=36 Treatment

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

Obesity · Pharmacokinetics · MRSA · Tuberculosis · PCP

Bottom Line

View on ClinicalTrials.gov: NCT01167452 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2016

Primary outcome: Primary: Elimination Rate Constants for Sulfamethoxazole and Trimethoprim — 0.060; 0.03 hr-1 — p=0.0004

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Sulfamethoxazole/trimethoprim (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Texas Tech University Health Sciences Center
Primary completion: May 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Elimination Rate Constants for Sulfamethoxazole and Trimethoprim	0.060; 0.03	0.0004 sig

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.

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 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01167452). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.