Clinical trial NCT01169038: Investigation of the Efficacy of Antibiotics on Pulmonary Sarcoidosis
Official title: Investigation of the Efficacy of Antibiotics on Pulmonary Sarcoidosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pulmonary Sarcoidosis
Lung Function
Keywords: sarcoidosis
mycobacteria
lung
pulmonary
radiographic improvement
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
First posted: 2010-07-23
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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 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.

Primary outcomes:
measure: Change in Absolute FVC From Baseline to Post Completion of 8 Weeks of Antibiotic Therapy.
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University School of Medicine
state: Tennessee
Study officials:
affiliation: Vanderbilt University School of Medicine
name: Wonder P Drake, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Drake WP, Richmond BW, Oswald-Richter K, Yu C, Isom JM, Worrell JA, Shipley GR. Effects of broad-spectrum antimycobacterial therapy on chronic pulmonary sarcoidosis. Sarcoidosis Vasc Diffuse Lung Dis. 2013 Nov 25;30(3):201-11.