Phase II Investigation of Antimycobacterial Therapy on Progressive, Pulmonary Sarcoidosis

NCT02024555 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 97

Last updated 2020-07-09

Study results available
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Summary

The primary purpose of this study is to investigate the efficacy and safety of oral antimycobacterial therapy in patients with confirmed progressive pulmonary sarcoidosis. We suspect that the CLEAR regimen will improve the absolute FVC percent predicted in chronic pulmonary sarcoidosis participants.

Conditions

  • Sarcoidosis; Antimycobacterial Therapy

Interventions

DRUG

Levofloxacin

DRUG

Ethambutol

DRUG

Rifampin

DRUG

Placebo

This will serve as a placebo to the antibiotics used in antimycobacterial therapy.

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH
  • Vanderbilt University

    lead OTHER

Principal Investigators

  • Wonder Drake, MD · Vanderbilt University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2019-04-01
Completion
2019-04-01

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02024555 on ClinicalTrials.gov