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NCT01169038 · ClinicalTrials.gov registry record · Phase 1

Investigation of the Efficacy of Antibiotics on Pulmonary Sarcoidosis

A Phase 1 study, sponsored by Vanderbilt University.

Completed
Registry status
Phase 1
Development phase
15
Enrollment target

NCT01169038: Completed Phase 1 study, sponsored by Vanderbilt University.

NCT01169038 is a Phase 1 study that has completed, run by Vanderbilt University. The registered enrollment target is 15 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01169038, a Phase 1 study, has completed, sponsored by Vanderbilt University.

COMPLETED
Registry status
Phase 1
Development phase
15 participants
Enrollment target

Study 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.

Primary Outcome

The primary endpoint was improvement in absolute FVC from baseline to completion of therapy. Spirometry testing was performed using a standardized calibrated laptop spirometer, Flowscreen II USA Spirometer (VIASYS Healthcare Inc., Yorba Linda, CA). The volume accuracy of the spirometer was checked daily using a three liter calibration syringe. Each subject was given at least three attempts and the greatest measurement for absolute FVC and Forced Expiratory Volume (FEV1) at baseline, four week, a

Interventions

  • DRUG levaquin; ethambutol; rifampin and azithromycin.

Trial Details

FieldValue
Enrollment Target 15 participants
Start Date 2010-07
Est. Completion 2010-11
Phase Phase 1
Vanderbilt University

430 total trials

What the finished NCT01169038 record still lists

NCT01169038 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower).

The record links to 0 conditions, and to 1 intervention - of which levaquin; ethambutol; rifampin and azithromycin. is the first listed.

NCT01169038 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01169038 about?

NCT01169038 is a clinical study titled "Investigation of the Efficacy of Antibiotics on Pulmonary Sarcoidosis". 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...

What is the current status of trial NCT01169038?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2010-07. Estimated completion is 2010-11.

What interventions are being tested in trial NCT01169038?

The interventions under investigation include: levaquin; ethambutol; rifampin and azithromycin. (DRUG).

Who is sponsoring clinical trial NCT01169038?

This trial is sponsored by Vanderbilt University, which has 430 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01169038's enrollment target sits among peer trials

15 1798th of 2000 higher than 157 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01169038, the US trial registry maintained by the National Library of Medicine. NCT01169038 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.