Trial Outcomes & Findings for Investigation of the Efficacy of Antibiotics on Pulmonary Sarcoidosis (NCT NCT01169038)

Last Updated: 2012-10-31

Results Overview

The primary endpoint was improvement in absolute FVC from baseline to completion of therapy. Spirometry testing was performed using a standardized calibrated laptop spirometer, Flowscreen II USA Spirometer (VIASYS Healthcare Inc., Yorba Linda, CA). The volume accuracy of the spirometer was checked daily using a three liter calibration syringe. Each subject was given at least three attempts and the greatest measurement for absolute FVC and Forced Expiratory Volume (FEV1) at baseline, four week, and eight week assessments was recorded.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

15 participants

Primary outcome timeframe

8 weeks

Results posted on

2012-10-31

Participant Flow

Participants were recruited from outpatient pulmonary clinics at Vanderbilt University Medical Center and the surrounding community between July 14 and August 24, 2010. All patients met American Thoracic Society/European Respiratory Society/World Association of Sarcoidosis and Other Granulomatous Diseases (ATS/ERS/WASOG) criteria.

Participant milestones

Participant milestones
Measure	Antibiotics Levaquin 750 mg loading on day 1, then 500 mg po QD Ethambutol 15-25 mg/kg for a maximum of 1200mg po QD Azithromycin 500mg on day 1, then 250 mg po QD \\Rifampin 10 mg/kg for a maximum of 600mg po QD or Rifabutin 10 mg/kg for a maximum of 300 mg po QD. \\We will not use both, but either one or the other based upon if the patient is on other medications that are metabolized by the cytochrome P450 pathway.
Overall Study STARTED	15
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Antibiotics Levaquin 750 mg loading on day 1, then 500 mg po QD Ethambutol 15-25 mg/kg for a maximum of 1200mg po QD Azithromycin 500mg on day 1, then 250 mg po QD \\Rifampin 10 mg/kg for a maximum of 600mg po QD or Rifabutin 10 mg/kg for a maximum of 300 mg po QD. \\We will not use both, but either one or the other based upon if the patient is on other medications that are metabolized by the cytochrome P450 pathway.
Overall Study Death	1
Overall Study Adverse Event	5
Overall Study Required antibiotic administration	1

Baseline Characteristics

Investigation of the Efficacy of Antibiotics on Pulmonary Sarcoidosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Antibiotics n=15 Participants Levaquin 750 mg loading on day 1, then 500 mg po QD Ethambutol 15-25 mg/kg for a maximum of 1200mg po QD Azithromycin 500mg on day 1, then 250 mg po QD \\Rifampin 10 mg/kg for a maximum of 600mg po QD or Rifabutin 10 mg/kg for a maximum of 300 mg po QD. \\We will not use both, but either one or the other based upon if the patient is on other medications that are metabolized by the cytochrome P450 pathway.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	54 years STANDARD_DEVIATION 2 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks

Population: In the ITT analysis, we included the values from the last measured value for those who did not complete the trial. We analyzed the measured value at 8 weeks among those subjects who completed 8 weeks of therapy in the per protocol analysis.

Outcome measures

Outcome measures
Measure	Antibiotics n=15 Participants Levaquin 750 mg loading on day 1, then 500 mg po QD Ethambutol 15-25 mg/kg for a maximum of 1200mg po QD Azithromycin 500mg on day 1, then 250 mg po QD \\Rifampin 10 mg/kg for a maximum of 600mg po QD or Rifabutin 10 mg/kg for a maximum of 300 mg po QD. \\We will not use both, but either one or the other based upon if the patient is on other medications that are metabolized by the cytochrome P450 pathway.
Change in Absolute FVC From Baseline to Post Completion of 8 Weeks of Antibiotic Therapy.	2.61 liters Standard Deviation 1.01

Adverse Events

Antibiotics

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Antibiotics n=15 participants at risk Levaquin 750 mg loading on day 1, then 500 mg po QD Ethambutol 15-25 mg/kg for a maximum of 1200mg po QD Azithromycin 500mg on day 1, then 250 mg po QD \\Rifampin 10 mg/kg for a maximum of 600mg po QD or Rifabutin 10 mg/kg for a maximum of 300 mg po QD. \\We will not use both, but either one or the other based upon if the patient is on other medications that are metabolized by the cytochrome P450 pathway.
Musculoskeletal and connective tissue disorders Arthalgias	13.3% 2/15 • Number of events 2 • The AE were collected over six months.
Nervous system disorders Headache	13.3% 2/15 • Number of events 2 • The AE were collected over six months.
General disorders Insomnia	6.7% 1/15 • Number of events 1 • The AE were collected over six months.
Cardiac disorders hypotension	6.7% 1/15 • Number of events 1 • The AE were collected over six months.
Blood and lymphatic system disorders leucopenia	6.7% 1/15 • Number of events 1 • The AE were collected over six months.
Respiratory, thoracic and mediastinal disorders pneumonia	6.7% 1/15 • Number of events 1 • The AE were collected over six months.
Skin and subcutaneous tissue disorders rash	6.7% 1/15 • Number of events 1 • The AE were collected over six months.

Additional Information

Wonder Drake

Vanderbilt University

Phone: 615-322-2035

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place