Investigation of the Efficacy of Antibiotics on Pulmonary Sarcoidosis (CLEAR Lung)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Wonder Drake, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT01169038
First received: July 22, 2010
Last updated: October 26, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
Pulmonary Sarcoidosis
Lung Function
Drug: levaquin; ethambutol; rifampin and azithromycin.
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Investigation of the Efficacy of Antibiotics on Pulmonary Sarcoidosis

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Change in Absolute FVC From Baseline to Post Completion of 8 Weeks of Antibiotic Therapy. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    The primary endpoint was improvement in absolute FVC from baseline to completion of therapy. Spirometry testing was performed using a standardized calibrated laptop spirometer, Flowscreen II USA Spirometer (VIASYS Healthcare Inc., Yorba Linda, CA). The volume accuracy of the spirometer was checked daily using a three liter calibration syringe. Each subject was given at least three attempts and the greatest measurement for absolute FVC and Forced Expiratory Volume (FEV1) at baseline, four week, and eight week assessments was recorded.


Enrollment: 15
Study Start Date: July 2010
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Antibiotics

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.

Drug: levaquin; ethambutol; rifampin and azithromycin.

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.


  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01169038

Locations
United States, Tennessee
Vanderbilt University School of Medicine
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Wonder P Drake, MD Vanderbilt University School of Medicine
  More Information

No publications provided

Responsible Party: Wonder Drake, Associate Professor of Medicine, Vanderbilt University
ClinicalTrials.gov Identifier: NCT01169038     History of Changes
Other Study ID Numbers: 100552
Study First Received: July 22, 2010
Results First Received: September 17, 2012
Last Updated: October 26, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
sarcoidosis
mycobacteria
lung
pulmonary
radiographic improvement

Additional relevant MeSH terms:
Sarcoidosis
Sarcoidosis, Pulmonary
Lymphoproliferative Disorders
Lymphatic Diseases
Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases
Anti-Bacterial Agents
Ethambutol
Ofloxacin
Levofloxacin
Rifampin
Azithromycin
Antibiotics, Antitubercular
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents
Anti-Infective Agents, Urinary
Renal Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Leprostatic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on August 19, 2014