Trial · NCT02024555

Phase II Investigation of Antimycobacterial Therapy on Progressive, Pulmonary Sarcoidosis

NCT02024555, Phase 2, Completed, Vanderbilt University; results first posted 2020-07-09

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Phase II Investigation of Antimycobacterial Therapy on Progressive, Pulmonary Sarcoidosis. Trials, record NCT02024555. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02024555

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Phase II Investigation of Antimycobacterial Therapy on Progressive, Pulmonary Sarcoidosis
NCT number: NCT02024555
Status: Completed
Phases: Phase 2
Enrollment: 97 participants, actual
Lead sponsor: Vanderbilt University
Conditions: Sarcoidosis; Antimycobacterial Therapy
Interventions: Levofloxacin, Ethambutol, Azithromycin, Rifampin, Placebo
First posted: 2013-12-31
Last updated: 2020-07-09
Results first posted: 2020-07-09

Source ClinicalTrials.gov

Registered outcomes12

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change in Percent Predicted Absolute Forced Vital Capacity (FVC) in Participants With Pulmonary Sarcoidosis, Comparing Baseline With Performance After Completion of 16 Weeks of Therapy.	Baseline to 16 weeks	Change in percent predicted absolute forced vital capacity (FVC) in participants with pulmonary sarcoidosis, comparing baseline with performance after completion of 16 weeks of therapy. This will involve comparing sarcoidosis and placebo after 16 weeks of therapy.
Secondary	Radiographic Improvement in Sarcoidosis Lung Disease by Frontal Chest X-ray .	Baseline and 16 weeks	Radiographic improvement in sarcoidosis lung disease by frontal chest x-ray . Local investigators will score chest x-rays.
Secondary	Six Minute Walk, Distance in Meters	Baseline, 4, 8, and 16 and 24 weeks	The 6-min walk test (6 MWT) is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes.
Secondary	Change in Oxygen Saturation	Baseline, 4, 8, and 16 and 24 weeks	measured using pulse oximetry
Secondary	Change in Level of Dyspnea	Baseline, 4, 8 and 16 weeks	Outcome measure if a composite
Secondary	Change in the Saint George's Respiratory Questionnaire (SGRQ)	Baseline and 16 weeks	The SGRQ is a 50-item questionnaire developed to measure health status (quality of life) in patients with diseases of airways obstruction. Scores range from 0 to 100, with higher scores indicating more limitations. A minimum change in score of 4 units was established as clinically relevant after patient and clinician testing.
Secondary	Fatigue Assessment Scale (FAS).	Baseline, 4, 8, 16 and 24 weeks	The FAS is a 10-item general fatigue questionnaire to assess fatigue. Total scores can range from 10, indicating the lowest level of fatigue, to 50, denoting the highest.
Secondary	Change in the King's Sarcoidosis Questionnaire (KSQ) for the Assessment of Health Status;	Baseline and 16 weeks	The KSQ is a free, online questionnaire to be filled out by sarcoidosis patients. The questionnaire takes around 10 minutes and is split into 5 sections; general health status, lungs, medication, skin and eyes. There are 29 questions in total, however some questions may not be answered (depending on the type of sarcoidosis affected). Each question asks patients to rate how they feel about many different aspects of their life, for instance how much pain they are in or how difficult they find everyday tasks. Information provided is confidential. Results are given as a number between 1-100 with higher numbers indicating better health.
Secondary	Adverse Events	24 weeks	Safety profile of regimen as evidenced by the number of adverse events
Secondary	FEV1%	Baseline, 4, 8, and 16 and 24 weeks	FEV1% was measure pre and post 6 minute walk test

1 to 10 of 12Source ClinicalTrials.gov

See all 12 registered outcomes

Outcomes12

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change in Percent Predicted Absolute Forced Vital Capacity (FVC) in Participants With Pulmonary Sarcoidosis, Comparing Baseline With Performance After Completion of 16 Weeks of Therapy.	Baseline to 16 weeks	Only 43 participants in each arm completed this measure	percentage predicted absolute FVC	MEAN
SECONDARY	Radiographic Improvement in Sarcoidosis Lung Disease by Frontal Chest X-ray .	Baseline and 16 weeks	The outcome was not completed due to lack of funds for radiology services.
SECONDARY	Six Minute Walk, Distance in Meters	Baseline, 4, 8, and 16 and 24 weeks	Week 24 assessment was optional. Not all participants completed the 6 minute walk test.	meters	MEAN
SECONDARY	Change in Oxygen Saturation	Baseline, 4, 8, and 16 and 24 weeks	not all participants completed the measure and it was not recorded at week 24	percentage of oxygen saturation	MEAN
SECONDARY	Change in Level of Dyspnea	Baseline, 4, 8 and 16 weeks	this measure was not administered
SECONDARY	Change in the Saint George's Respiratory Questionnaire (SGRQ)	Baseline and 16 weeks	questionnaire was only administered at baseline and 16 weeks and not all participants completed the questionnaire at week 16	score on a scale	MEAN
SECONDARY	Fatigue Assessment Scale (FAS).	Baseline, 4, 8, 16 and 24 weeks	The FAS was not administered to participants.
SECONDARY	Change in the King's Sarcoidosis Questionnaire (KSQ) for the Assessment of Health Status;	Baseline and 16 weeks	KSQ was not administered to participants.
SECONDARY	Adverse Events	24 weeks		number of events	NUMBER
SECONDARY	FEV1%	Baseline, 4, 8, and 16 and 24 weeks	Week 24 assessment was optional. Not all participants completed all measurements	Percentage of predicted FEV1	MEAN

1 to 10 of 12Source ClinicalTrials.gov

See all 12 outcomes

Results by group54

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Change in Percent Predicted Absolute Forced Vital Capacity (FVC) in Participants With Pulmonary Sarcoidosis, Comparing Baseline With Performance After Completion of 16 Weeks of Therapy.	Concomitant Levaquin, Ethambutol, Azithromycin and Rifampin		0.35	Standard Deviation 6.76	percentage predicted absolute FVC
Change in Percent Predicted Absolute Forced Vital Capacity (FVC) in Participants With Pulmonary Sarcoidosis, Comparing Baseline With Performance After Completion of 16 Weeks of Therapy.	Placebo		0.17	Standard Deviation 7.2	percentage predicted absolute FVC
Six Minute Walk, Distance in Meters	Concomitant Levaquin, Ethambutol, Azithromycin and Rifampin	Baseline	416.25	Standard Error 140.69	meters
Six Minute Walk, Distance in Meters	Placebo	Baseline	416.41	Standard Error 105.15	meters
Six Minute Walk, Distance in Meters	Concomitant Levaquin, Ethambutol, Azithromycin and Rifampin	Week 4	432.65	Standard Error 155.5	meters
Six Minute Walk, Distance in Meters	Placebo	Week 4	428.35	Standard Error 92.36	meters
Six Minute Walk, Distance in Meters	Concomitant Levaquin, Ethambutol, Azithromycin and Rifampin	Week 8	451.59	Standard Error 146.12	meters
Six Minute Walk, Distance in Meters	Placebo	Week 8	420.21	Standard Error 93.9	meters
Six Minute Walk, Distance in Meters	Concomitant Levaquin, Ethambutol, Azithromycin and Rifampin	Week 16	440.37	Standard Error 137.08	meters
Six Minute Walk, Distance in Meters	Placebo	Week 16	430.85	Standard Error 111.96	meters

1 to 10 of 54Source ClinicalTrials.gov

See all 54 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Concomitant Levaquin, Ethambutol, Azithromycin and Rifampin	49
Overall Study	STARTED	Placebo	48
Overall Study	COMPLETED	Concomitant Levaquin, Ethambutol, Azithromycin and Rifampin	43
Overall Study	COMPLETED	Placebo	46
Overall Study	NOT COMPLETED	Concomitant Levaquin, Ethambutol, Azithromycin and Rifampin	6
Overall Study	NOT COMPLETED	Placebo	2

Source ClinicalTrials.gov

Adverse events154

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Low Platelet count	Blood and lymphatic system disorders	Concomitant Levaquin, Ethambutol, Azithromycin and Rifampin	1	49
other	Low Platelet count	Blood and lymphatic system disorders	Placebo	0	48
other	Low WBC Count	Blood and lymphatic system disorders	Concomitant Levaquin, Ethambutol, Azithromycin and Rifampin	1	49
other	Low WBC Count	Blood and lymphatic system disorders	Placebo	0	48
other	leukopenia	Blood and lymphatic system disorders	Concomitant Levaquin, Ethambutol, Azithromycin and Rifampin	1	49
other	leukopenia	Blood and lymphatic system disorders	Placebo	0	48
other	WBC Low	Blood and lymphatic system disorders	Concomitant Levaquin, Ethambutol, Azithromycin and Rifampin	1	49
other	WBC Low	Blood and lymphatic system disorders	Placebo	0	48
other	Low WBC	Blood and lymphatic system disorders	Concomitant Levaquin, Ethambutol, Azithromycin and Rifampin	1	49
other	Low WBC	Blood and lymphatic system disorders	Placebo	0	48

1 to 10 of 154Source ClinicalTrials.gov

See all 154 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Concomitant Levaquin, Ethambutol, Azithromycin and Rifampin	0	49
Total, all-cause mortality	Placebo	0	48
Total, other adverse events	Concomitant Levaquin, Ethambutol, Azithromycin and Rifampin	24	49
Total, other adverse events	Placebo	16	48
Total, serious adverse events	Concomitant Levaquin, Ethambutol, Azithromycin and Rifampin	4	49
Total, serious adverse events	Placebo	3	48

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
R01HL117074	Microbial induction of sarcoidosis CD4+ T cell dysfunction	DRAKE, WONDER P.; BERNARD, GORDON RAPHAEL	VANDERBILT UNIVERSITY MEDICAL CENTER	NATIONAL HEART, LUNG, AND BLOOD INSTITUTE	2013 to 2017

Source NIH RePORTER

Trial comparisons3

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Concomitant Levaquin, Ethambutol, Azithromycin and Rifampin vs Placebo: Failure of Standard Therapy	Trial comparisons
Concomitant Levaquin, Ethambutol, Azithromycin and Rifampin vs Placebo: deaths from any cause	Trial comparisons
Concomitant Levaquin, Ethambutol, Azithromycin and Rifampin vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02024555

GET https://conductscience.org/api/trials/v1/NCT02024555/results?page=2

API reference For AI assistants