Phase 1
N=15
Investigation of the Efficacy of Antibiotics on Pulmonary Sarcoidosis
Pulmonary Sarcoidosis · Lung Function
Bottom Line
View on ClinicalTrials.gov: NCT01169038 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Oct 2012
Primary outcome: Primary: Change in Absolute FVC From Baseline to Post Completion of 8 Weeks of Antibiotic Therapy. — 2.61 liters
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- levaquin; ethambutol; rifampin and azithromycin. (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Vanderbilt University
- Primary completion
- Nov 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Absolute FVC From Baseline to Post Completion of 8 Weeks of Antibiotic Therapy. |
2.61 | — |
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.
- 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 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.
- Subject has been hospitalized for infection or received IV antibiotics within the previous 2 months prior to baseline.
- 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.
- 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.
- 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.
- No smoking for past one year.
Data sourced from ClinicalTrials.gov (NCT01169038). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.