Clinical trial: Investigation of the Efficacy of Antibiotics on Pulmonary Sarcoidosis (NCT01169038)

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.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 75 Years

Patient description (medical language): A 39-year-old woman comes to the clinic complaining of arthralgias and nodules on her legs.  She has no fever or other skin rashes. The prior medical condition is unremarkable, and she takes no medications.  On physical examination, there is moderate hepatomegaly. The lesions on her legs are tender and present predominantly on the anterior surface of the lower extremities. She doesn't smoke and drinks alcohol occasionally. The patient has 2 male sexual partners. Vital signs are normal. Chest x-ray demonstrates enlarged hilar lymph nodes, and laboratory testing reveals an elevated ACE level. Biopsy of the skin lesion shows noncaseating granulomas that stain negative for fungi & acid-fast bacilli.

Patient description (patient's own words): I'm just a 39-year-old young woman but lately I have noticed some underlying cysts on my legs and my joints were hurting so much. I don't have a fever. I don't have rashes. My medical history is totally clean and I don't take any medication. When I went to the clinic they did a physical examination where they found that my liver is enlarged. They also found that the lesions on my legs are kind of tender and they are located on the front side of my legs. I do not smoke and I drink alcohol occasionally. I have to male sexual partners. On the day of my visit my vitals were fine. I did an X-ray of my chest and I had swollen lymph nodes. I also has a blood test and it came back with a high ACE level. I also had a biopsy of my skin lesions that came back negative for fungi and AFB.

Does the patient match the trial criteria? 1