Investigation of the Efficacy of Antibiotics on Pulmonary Sarcoidosis
Condition: Pulmonary Sarcoidosis; Lung Function
MeSH terms: Sarcoidosis, Pulmonary; Sarcoidosis
Intervention: levaquin; ethambutol; rifampin and azithromycin.
Intervention 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.
Intervention MeSH terms: Azithromycin; Rifampin; Ethambutol; Levofloxacin
Phase: Phase 1
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: sarcoidosis; mycobacteria; lung; pulmonary; radiographic improvement

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with sarcoidosis will be enrolled as defined below.

               1. Patients with sarcoidosis as defined by the ATS/ERS/WASOG statement on
                  sarcoidosis as defined by the clinical presentation consistent with sarcoidosis,
                  as well as biopsy finding granulomas, and no alternative for the cause of the
                  granulomas, such as tuberculosis.

               2. Evidence of parenchymal disease on chest radiograph (Stage II, III or IV) or
                  Stage I disease by chest radiographs and evidence of abnormal spirometry. .
                  Subjects with concurrent extrapulmonary sarcoidosis, particularly skin and eye
                  involvement, can be enrolled.

               3. FVC of >=45% and <=80% of predicted normal value at screening.

               4. 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:

                    1. condoms, sponge, foams, jellies, diaphragm, or intrauterine device

                    2. contraceptives (oral or parenteral) for three months prior to study drug
                       administration

                    3. a vasectomized sole partner

                    4. Females of childbearing potential must have a negative urine pregnancy test
                       at screening visit.

        Exclusion Criteria:

          -  1. 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.

             11. Subject has been hospitalized for infection or received IV antibiotics within the
             previous 2 months prior to baseline.

             12. Subject has a history of tuberculosis at anytime or close contact with a person
             with active tuberculosis within the previous 6 months, or persistent or active
             infections requiring hospitalization or treatment with IV antibiotics, IV
             antiretrovirals, or IV antifungals within 30 days of baseline, OR oral antibiotics,
             antivirals, or antifungals for purpose of treating infection, within 14 days of
             baseline.

             13. Subject has an active infection requiring systemic antibiotics at time of
             screening 14. Subject has a history of listeriosis, treated or untreated tuberculosis,
             exposure to individuals with tuberculosis.

             15. Have a diagnosis of other significant respiratory disorder other than sarcoidosis
             that would complicate the evaluation of response to treatment 16. Patients otherwise
             unsuitable for participation in the opinion of the investigator.

             17. No smoking for past one year.