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CompletedNCT01169038CLEAR LungUpdated Oct 31, 2012Results posted

Investigation of the Efficacy of Antibiotics on Pulmonary Sarcoidosis

A Phase 1 interventional study of levaquin; ethambutol; rifampin and azithromycin. in Pulmonary Sarcoidosis and Lung Function, sponsored by Vanderbilt University. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2012-10-31.

Sponsored by Vanderbilt University · Phase 1, Interventional, and Diagnostic

Phase
Phase 1
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Pulmonary Sarcoidosis
  • Lung Function

Keywords

  • sarcoidosis
  • mycobacteria
  • lung
  • pulmonary
  • radiographic improvement
03

In context

Sarcoidosis, Pulmonary

63 studies on the registry are indexed under Sarcoidosis, Pulmonary; 15 are open to participants now.

This study's enrollment of 15 is below the median of 53 across 48 interventional studies indexed under Sarcoidosis, Pulmonary.

Browse Sarcoidosis, Pulmonary studies →

Lead sponsor

Vanderbilt University is the lead sponsor of 508 studies on the registry; 19 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 5 (71%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.

      1. Subject has been hospitalized for infection or received IV antibiotics within the previous 2 months prior to baseline.
      1. 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.
      1. 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.
      1. 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.
      1. No smoking for past one year.
05

Study design

Phase
Phase 1
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (actual)

Study arms

  • 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.

Interventions

  • Druglevaquin; 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.

06

What researchers measure

Primary outcomes

  1. Change in Absolute FVC From Baseline to Post Completion of 8 Weeks of Antibiotic Therapy.

    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.

    Time frame: 8 weeks

07

Results

Posted Oct 19, 2012

Participant flow

Participants were recruited from outpatient pulmonary clinics at Vanderbilt University Medical Center and the surrounding community between July 14 and August 24, 2010. All patients met American Thoracic Society/European Respiratory Society/World Association of Sarcoidosis and Other Granulomatous Diseases (ATS/ERS/WASOG) criteria.

Participant flow — Overall Study
MilestoneAntibiotics
Started15
Completed8
Not completed7
Withdrew: Death1
Withdrew: Adverse event5
Withdrew: Required antibiotic administration1

Outcome measures

PrimaryChange in Absolute FVC From Baseline to Post Completion of 8 Weeks of Antibiotic Therapy.

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.

Time frame:
8 weeks
Reported as:
Mean · liters
Change in Absolute FVC From Baseline to Post Completion of 8 Weeks of Antibiotic Therapy.
litersAntibiotics
Change in Absolute FVC From Baseline to Post Completion of 8 Weeks of Antibiotic Therapy.2.61 ± 1.01

Adverse events

Collected over The AE were collected over six months.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Antibiotics—0/15 (0%)8/15 (53.3%)
Most frequent other events
Most frequent other events
EventAntibiotics
ArthalgiasMusculoskeletal and connective tissue disorders2/15
HeadacheNervous system disorders2/15
InsomniaGeneral disorders1/15
hypotensionCardiac disorders1/15
leucopeniaBlood and lymphatic system disorders1/15
pneumoniaRespiratory, thoracic and mediastinal disorders1/15
rashSkin and subcutaneous tissue disorders1/15

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Antibiotics
<=18 years0
Between 18 and 65 years15
>=65 years0
Age Continuous
Age Continuous(years)Antibiotics
Mean54 ± 2
Sex: Female, Male
Sex: Female, Male(Participants)Antibiotics
Female11
Male4
Region of Enrollment
Region of Enrollment(participants)Antibiotics
United States15
08

Study locations

1 site
  • Vanderbilt University School of Medicine
    Nashville, Tennessee 37232, United States
09

References and documents

Publications

  • 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. PubMed 24284293 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 31, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01169038
Lead sponsor
Vanderbilt University
Responsible party
Wonder Drake (Associate Professor of Medicine, Vanderbilt University) — Principal investigator
First posted
Jul 23, 2010
Start date
Jul 2010
Primary completion
Nov 2010
Completion
Nov 2010
Results posted
Oct 19, 2012
Last update
Oct 31, 2012

Study contacts

Wonder P Drake, MD
principal investigator · Vanderbilt University School of Medicine

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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