Efficacy of Macrolide Immunomodulation in Severe Sepsis.
NCT00708799 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2017-04-21
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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