Trial Outcomes & Findings for Effect of Weight and/or Obesity on Sulfamethoxazole and Trimethoprim Concentrations (NCT NCT01167452)

NCT ID: NCT01167452

Last Updated: 2017-06-14

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 36 participants
• Primary outcome timeframe: 24 hours
• Results posted on: 2017-06-14

Participant Flow

Participant milestones

Measure	Sulfamethoxazole/Trimethoprim 2 DS tablets of sulfamehtoxazole/trimethoprim (1600 mg/320 mg) Sulfamethoxazole/trimethoprim: 2 DS tablets of trimethoprim/sulfamethoxazole x 1 dose
Overall Study STARTED	36
Overall Study COMPLETED	36
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Sulfamethoxazole/Trimethoprim n=36 Participants All volunteers received a single dose oral dose of TMP/SMX (1600 mg/320 mg).
Age, Categorical <=18 years	1 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	34 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age, Continuous	37 years n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants
Region of Enrollment United States	36 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 hours

Outcome measures

Measure	Sulfamethoxazole n=36 Participants Results from sulfamethoxazole analysis	Trimethoprim n=36 Participants Results from trimethoprim analysis
Elimination Rate Constants for Sulfamethoxazole and Trimethoprim	0.060 hr-1 Interval 0.015 to 0.18	0.03 hr-1 Interval 0.02 to 0.14

Adverse Events

Sulfamethoxazole/Trimethoprim

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Sulfamethoxazole/Trimethoprim n=36 participants at risk All volunteers received a single dose of TMP/SMX (1600 mg/320 mg).
Nervous system disorders Headache	8.3% 3/36 • Number of events 3 • 24 hours
Nervous system disorders Fainting	2.8% 1/36 • Number of events 1 • 24 hours

Additional Information

Ronald Hall, PharmD, MSCS

Texas Tech University Health Sciences Center

Phone: 214-358-9009

Email: ronald.hall@ttuhsc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place