Status:
COMPLETED
Investigation of the Efficacy of Antibiotics on Pulmonary Sarcoidosis
Lead Sponsor:
Vanderbilt University
Conditions:
Pulmonary Sarcoidosis
Lung Function
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief 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 ...
Eligibility Criteria
Inclusion
- Subjects with sarcoidosis will be enrolled as defined below.
- 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.
- 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.
- FVC of \>=45% and \<=80% of predicted normal value at screening.
- 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:
- condoms, sponge, foams, jellies, diaphragm, or intrauterine device
- contraceptives (oral or parenteral) for three months prior to study drug administration
- a vasectomized sole partner
- Females of childbearing potential must have a negative urine pregnancy test at screening visit.
Exclusion
- 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.
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT01169038
Start Date
July 1 2010
End Date
November 1 2010
Last Update
October 31 2012
Active Locations (1)
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1
Vanderbilt University School of Medicine
Nashville, Tennessee, United States, 37232