CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 30 enrolled
Drug / intervention
Antibiotic Regimen +1 moredrug
Likely dose
Antibiotic Regimen 750 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01074554
NCT01074554Phase 2Completed
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Phase I/II Study of the Effects of Antibiotics on Sarcoidosis Pathogenesis

Vanderbilt University·interventional·Posted Feb 24, 2010·Updated Dec 12, 2016

In Brief

A Phase 2 clinical trial evaluating Antibiotic Regimen and Placebo Regimen for Sarcoidosis. Completed, enrolled 30 participants across 1 site.

Detailed Summary

Growing research from independent laboratories provide an association between mycobacteria and sarcoidosis. More recent immunologic and molecular studies demonstrate immune responses to mycobacteria virulence factors. The purpose of this study is to assess if administration of anti-mycobacterial drug therapy will aid in resolution of cutaneous sarcoidosis lesions.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSarcoidosis
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 24, 2010
Enrollment StartFeb 1, 2010
Primary CompletionFeb 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 16.4 years ago

Interventions

Antibiotic Regimendrug

Levaquin 750 mg loading on day 1, then 500 mg po QD Ethambutol 15-25 mg/kg for a maximum of 1200mg QD Azithromycin 500mg on day 1, then 250 mg po QD Rifampin 5-10 mg/kg for a maximum of 300mg po QD All four drugs are given concomitanly

Placebo Regimendrug

lactose control tablets; one for each antibiotic with equivalent pills