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Investigation of the Efficacy of Antibiotics on Pulmonary Sarcoidosis (CLEAR Lung)

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ClinicalTrials.gov Identifier: NCT01169038
Recruitment Status : Completed
First Posted : July 23, 2010
Results First Posted : October 19, 2012
Last Update Posted : October 31, 2012
Sponsor:
Information provided by (Responsible Party):
Wonder Drake, Vanderbilt University

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Conditions Pulmonary Sarcoidosis
Lung Function
Intervention Drug: levaquin; ethambutol; rifampin and azithromycin.
Enrollment 15
Recruitment Details 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.
Pre-assignment Details  
Arm/Group Title Antibiotics
Hide Arm/Group Description

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.

Period Title: Overall Study
Started 15
Completed 8
Not Completed 7
Reason Not Completed
Death             1
Adverse Event             5
Required antibiotic administration             1
Arm/Group Title Antibiotics
Hide Arm/Group Description

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 Number of Baseline Participants 15
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
<=18 years
0
   0.0%
Between 18 and 65 years
15
 100.0%
>=65 years
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants
54  (2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
Female
11
  73.3%
Male
4
  26.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants
15
1.Primary Outcome
Title Change in Absolute FVC From Baseline to Post Completion of 8 Weeks of Antibiotic Therapy.
Hide Description 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.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Antibiotics
Hide Arm/Group Description:

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 Number of Participants Analyzed 15
Mean (Standard Deviation)
Unit of Measure: liters
2.61  (1.01)
Time Frame The AE were collected over six months.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Antibiotics
Hide Arm/Group Description

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.

All-Cause Mortality
Antibiotics
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Antibiotics
Affected / at Risk (%) # Events
Total   0/15 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Antibiotics
Affected / at Risk (%) # Events
Total   8/15 (53.33%)    
Blood and lymphatic system disorders   
leucopenia  1  1/15 (6.67%)  1
Cardiac disorders   
hypotension  1  1/15 (6.67%)  1
General disorders   
Insomnia  1  1/15 (6.67%)  1
Musculoskeletal and connective tissue disorders   
Arthalgias  1  2/15 (13.33%)  2
Nervous system disorders   
Headache  1  2/15 (13.33%)  2
Respiratory, thoracic and mediastinal disorders   
pneumonia  1  1/15 (6.67%)  1
Skin and subcutaneous tissue disorders   
rash  1  1/15 (6.67%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.0)
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Wonder Drake
Organization: Vanderbilt University
Phone: 615-322-2035
EMail: wonder.drake@vanderbilt.edu
Layout table for additonal information
Responsible Party: Wonder Drake, Vanderbilt University
ClinicalTrials.gov Identifier: NCT01169038    
Other Study ID Numbers: 100552
First Submitted: July 22, 2010
First Posted: July 23, 2010
Results First Submitted: September 17, 2012
Results First Posted: October 19, 2012
Last Update Posted: October 31, 2012