Trial Outcomes & Findings for Effect of Weight and/or Obesity on Ethambutol Drug Concentrations (NCT NCT01048697)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

18 participants

Primary outcome timeframe

Blood samples will be collected over a 24 hour period (0, 2, 6, 11, 18, and 24 hours)

Results posted on

2013-01-24

Recruitment of volunteers by fliers.

Participant milestones
Measure	Ethambutol All volunteers received a single dose of oral ethambutol based on American Thoracic Society/Centers for Disease Control and Prevention/Infectious Diseases Society of American (ATS/CDC/IDSA) TB treatment guidelines. No doses were higher than the maximum dose recommended for daily administration by the current ATS/CDC/IDSA TB guidelines (which use ideal body weight for dosing): 40-55kg: 800 mg (two 400 mg tablets) 56-75kg: 1,200 mg (three 400 mg tablets) 76-90kg: 1,600 mg (four 400 mg tablets) \> 90 kg: No dosage recommendations so these volunteers will only receive 1,600 mg (four 400 mg tablets)
Overall Study STARTED	18
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	0

Withdrawal data not reported

Effect of Weight and/or Obesity on Ethambutol Drug Concentrations

Baseline characteristics by cohort
Measure	Ethambutol n=18 Participants All volunteers received a single dose of oral ethambutol based on American Thoracic Society/Centers for Disease Control and Prevention/Infectious Diseases Society of American (ATS/CDC/IDSA) TB treatment guidelines. No doses were higher than the maximum dose recommended for daily administration by the current ATS/CDC/IDSA TB guidelines (which use ideal body weight for dosing): 40-55kg: 800 mg (two 400 mg tablets) 56-75kg: 1,200 mg (three 400 mg tablets) 76-90kg: 1,600 mg (four 400 mg tablets) \> 90 kg: No dosage recommendations so these volunteers will only receive 1,600 mg (four 400 mg tablets)
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	18 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	36.6 years STANDARD_DEVIATION 11.3 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Region of Enrollment United States	18 participants n=5 Participants

Timeframe: Blood samples will be collected over a 24 hour period (0, 2, 6, 11, 18, and 24 hours)

Outcome measures
Measure	Ethambutol n=18 Participants All volunteers received a single dose of oral ethambutol based on American Thoracic Society/Centers for Disease Control and Prevention/Infectious Diseases Society of American (ATS/CDC/IDSA) TB treatment guidelines. No doses were higher than the maximum dose recommended for daily administration by the current ATS/CDC/IDSA TB guidelines (which use ideal body weight for dosing): 40-55kg: 800 mg (two 400 mg tablets) 56-75kg: 1,200 mg (three 400 mg tablets) 76-90kg: 1,600 mg (four 400 mg tablets) \> 90 kg: No dosage recommendations so these volunteers will only receive 1,600 mg (four 400 mg tablets)
Total Clearance of Ethambutol	80.8 L/h Standard Deviation 18.6

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	Ethambutol n=18 participants at risk All volunteers received a single dose of oral ethambutol based on American Thoracic Society/Centers for Disease Control and Prevention/Infectious Diseases Society of American (ATS/CDC/IDSA) TB treatment guidelines. No doses were higher than the maximum dose recommended for daily administration by the current ATS/CDC/IDSA TB guidelines (which use ideal body weight for dosing): 40-55kg: 800 mg (two 400 mg tablets) 56-75kg: 1,200 mg (three 400 mg tablets) 76-90kg: 1,600 mg (four 400 mg tablets) \> 90 kg: No dosage recommendations so these volunteers will only receive 1,600 mg (four 400 mg tablets)
General disorders Nosebleed	5.6% 1/18 • Number of events 1 • 24 hours

Texas Tech UHSC

Phone: 214-654-9404