The main purpose of this study is to investigate the efficacy and safety of oral antimycobacterial therapy in patients with confirmed progressive pulmonary sarcoidosis.
CLEAR is an acronym used to describe treatment with Combination Levofloxacin, Ethambutol, Azithromycin, and Rifampin, four medications being studied because of the thought that sarcoidosis might be influenced or caused by a type of infection. Researchers suspect that the CLEAR regimen will improve the forced vital capacity (FVC) or the amount of air that can be exhaled after taking the deepest breath possible in chronic pulmonary sarcoidosis participants.
This is a double-blind, placebo-controlled study. That means neither participants nor researchers know which participants are receiving the CLEAR therapy. Patients who are selected for the trial will be randomly assigned to one of two groups, the control group and experimental group. Those research participants in the control group will receive placebo, a treatment designed to have no real effect on their condition. Those participants in the experimental group will receive the CLEAR regimen.
Criteria that may make you able to participate in this trial include:
- Patients must be at least 18 years old
- Diagnosed with pulmonary sarcoidosis via biopsy demonstrating granulomas and no alternative cause for granulomas, such as tuberculosis for at least one year before joining this trial
- Evidence of disease progression
- Evidence of disease in lung and lymph node tissue in chest xray.
Criteria that may not allow for you to participate include:
- Participants cannot be less than 18 years old
- If you are female, you must either be unable to get pregnant or use a form of birth control for the duration of the study and 90 days after study completion
- Participants currently receiving more than 40mg prednisone.
- View more exclusion criteria
Locations currently recruiting:
- Albany, New York, USA – Albany Medical Center
Sub-Investigator Marc Judson, MD
Contact Marc Judson, MD at 518-262-0355 or judsonm@mail.amc.edu - Cincinnati, Ohio, USA – University of Cincinnati
Principal Investigator: Robert Baughman, MD - Cleveland, Ohio, USA – Cleveland Clinic
Principal Investigator: Daniel Culver, DO - Columbus, Ohio, USA – Ohio State University
Sub-Investigator: Elliott Crouser, MD
Contact: Elliott Crouser, MD at 614-293-4925 or elliott.crouser@osumc.edu
Contact: Karen Martin at 614-293-4978 or karen.martin@osumc.edu - Charleston, South Carolina, USA – Medical University of South Carolina
Principal Investigator: James Ennis, MD
Contact James Ennis, MD at 843-792-3769 or jamesw@musc.edu - Nashville, Tennessee, USA – Vanderbilt University
Principal Investigator: Wonder Drake, MD
Contact Wonder Drake, MD at 615-322-2035 or wonder.drake@vanderbilt.edu
If you qualify and are not local, travel arrangement may be arranged for you through the study coordinators. Participants will be reimbursed for study participation. To learn more, view the full trial information on clinicaltrials.gov.
Choosing to participate in a study is an important decision we encourage you to discuss with your physicians, family members, and friends. Every study comes with potential risks and benefits you should discuss thoroughly with you physicians and study coordinators.