A Phase 1 interventional study of levaquin; ethambutol; rifampin and azithromycin. in Pulmonary Sarcoidosis and Lung Function, sponsored by Vanderbilt University. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2012-10-31.
Sponsored by Vanderbilt University · Phase 1, Interventional, and Diagnostic
Sarcoidosis is a granulomatous disease for which the molecular and immunologic association with mycobacteria continues to strengthen. The investigators are interested in conducting a proof-of-concept investigation of the effects of antibiotics on sarcoidosis resolution. The investigators hypothesize that pulmonary sarcoidosis will improve faster if patients are given antimycobacterial therapy, in addition to their standard therapy.
63 studies on the registry are indexed under Sarcoidosis, Pulmonary; 15 are open to participants now.
This study's enrollment of 15 is below the median of 53 across 48 interventional studies indexed under Sarcoidosis, Pulmonary.
Browse Sarcoidosis, Pulmonary studies →Vanderbilt University is the lead sponsor of 508 studies on the registry; 19 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 5 (71%) have results posted.
Counted across the registry records on this site, refreshed daily.
Subjects with sarcoidosis will be enrolled as defined below.
If female, subject is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy), or is using one of the following methods of birth control for the duration of the study and 90 days after study completion:
Exclusion Criteria:
No consent/inability to obtain consent. 2. Age less than 18 years of age. 3. Inability to draw blood. 4. ALT or AST >5 times upper limit of normal (ULN) 5. Pregnancy or breast feeding. 6. Allergy to macrolides, quinolones or rifamycins. 7. Visual Impairment as defined by differentiating colors per personal history. 8. Family or personal history of long QT syndromes. 9. Patients receiving another interventional investigational drug for sarcoidosis within the 30 days prior to dosing 10. Use of any investigational medication within the past 28 days prior to study enrollment.
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.
Drug: levaquin; ethambutol; rifampin and azithromycin.
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.
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
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.
| Milestone | Antibiotics |
|---|---|
| Started | 15 |
| Completed | 8 |
| Not completed | 7 |
| Withdrew: Death | 1 |
| Withdrew: Adverse event | 5 |
| Withdrew: Required antibiotic administration | 1 |
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.
| liters | Antibiotics |
|---|---|
| Change in Absolute FVC From Baseline to Post Completion of 8 Weeks of Antibiotic Therapy. | 2.61 ± 1.01 |
Collected over The AE were collected over six months.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Antibiotics | — | 0/15 (0%) | 8/15 (53.3%) |
| Event | Antibiotics |
|---|---|
| ArthalgiasMusculoskeletal and connective tissue disorders | 2/15 |
| HeadacheNervous system disorders | 2/15 |
| InsomniaGeneral disorders | 1/15 |
| hypotensionCardiac disorders | 1/15 |
| leucopeniaBlood and lymphatic system disorders | 1/15 |
| pneumoniaRespiratory, thoracic and mediastinal disorders | 1/15 |
| rashSkin and subcutaneous tissue disorders | 1/15 |
| Age, Categorical(Participants) | Antibiotics |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 15 |
| >=65 years | 0 |
| Age Continuous(years) | Antibiotics |
|---|---|
| Mean | 54 ± 2 |
| Sex: Female, Male(Participants) | Antibiotics |
|---|---|
| Female | 11 |
| Male | 4 |
| Region of Enrollment(participants) | Antibiotics |
|---|---|
| United States | 15 |
This study is completed, as verified in Oct 2012. You cannot join it, but the record below documents what was studied.
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