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| ID | Type | Description | Link |
|---|---|---|---|
| 5UL1RR024982-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Research Resources (NCRR) | NIH |
| University of Texas Southwestern Medical Center | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sulfamethoxazole/trimethoprim | Experimental | 2 DS tablets of sulfamehtoxazole/trimethoprim (1600 mg/320 mg) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sulfamethoxazole/trimethoprim | Drug | 2 DS tablets of trimethoprim/sulfamethoxazole x 1 dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Elimination Rate Constants for Sulfamethoxazole and Trimethoprim | 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ronald Hall, PharmD, MSCS | Texas Tech UHSC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27869362 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sulfamethoxazole/Trimethoprim | 2 DS tablets of sulfamehtoxazole/trimethoprim (1600 mg/320 mg) Sulfamethoxazole/trimethoprim: 2 DS tablets of trimethoprim/sulfamethoxazole x 1 dose |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Sulfamethoxazole/Trimethoprim | All volunteers received a single dose oral dose of TMP/SMX (1600 mg/320 mg). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Elimination Rate Constants for Sulfamethoxazole and Trimethoprim | Posted | Median | Full Range | hr-1 | 24 hours |
|
|
24 hours
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sulfamethoxazole/Trimethoprim | All volunteers received a single dose of TMP/SMX (1600 mg/320 mg). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Non-systematic Assessment | Mild headache post-dose (possibly related) One person with a headache also had elevated blood pressure, skin irritation under the medical dressing over the IV line insertion site, and a mild rash (neck, ears); all deemed not related to study drug. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ronald Hall, PharmD, MSCS | Texas Tech University Health Sciences Center | 214-358-9009 | ronald.hall@ttuhsc.edu |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D014376 | Tuberculosis |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D015662 | Trimethoprim, Sulfamethoxazole Drug Combination |
| ID | Term |
|---|---|
| D013420 | Sulfamethoxazole |
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
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| Participants |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
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|
| 0 |
| 36 |
| 4 |
| 36 |
|
| Fainting | Nervous system disorders | Non-systematic Assessment | One person fainted during the screening blood draw, which we judged not to be related to study drug. |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D009930 |
| Organic Chemicals |
| D013424 | Sulfanilamides |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D014295 | Trimethoprim |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |