Efficacy of Macrolide Immunomodulation in Severe Sepsis.

NCT00708799 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2017-04-21

No results posted yet for this study

Summary

The purpose of this study is to determine whether macrolide treatment of patients with severe sepsis has an advantageous immunomodulatory and clinical effect compared to severe septic patients without macrolide therapy. Our main hypothesis is macrolide use in addition to standard therapy in severe septic patients has an advantageous immunomodulatory and clinical effect compared to patients with severe sepsis not treated with a macrolide.

Conditions

  • Systemic Inflammatory Response Syndrome

Interventions

OTHER

Azithromycin on admission - not enrolled in the RCT

One dose of azithromycin prior to inclusion to the RCT

Sponsors & Collaborators

  • Northwestern University Feinberg School of Medicine

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

    collaborator NIH
  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Marcos I Restrepo, MD BA MSc · South Texas Health Care System, San Antonio, TX

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2013-11-30
Completion
2013-11-30

Countries

  • United States

Study Locations

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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 NCT00708799 on ClinicalTrials.gov