CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 15 enrolled
Drug / intervention
levaquin; ethambutol; rifampin and azithromycin.drug
Likely dose
levaquin; ethambutol; rifampin and azithromycin. 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/NCT01169038
NCT01169038Phase 1Completed
CompareCT.gov

Investigation of the Efficacy of Antibiotics on Pulmonary Sarcoidosis

Vanderbilt University·interventional·Posted Jul 23, 2010·Updated Oct 31, 2012

In Brief

A Phase 1 clinical trial evaluating levaquin; ethambutol; rifampin and azithromycin. for Pulmonary Sarcoidosis and Lung Function. Completed, enrolled 15 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPulmonary Sarcoidosis, Lung Function
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJul 23, 2010
Enrollment StartJul 1, 2010
Primary CompletionNov 1, 2010
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 15.9 years ago

Interventions

levaquin; ethambutol; rifampin and azithromycin.drug

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.