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Sponsors and Collaborators: |
Department of Veterans Affairs University Hospital Feinberg School of Medicine, Northwestern University |
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Information provided by: | Department of Veterans Affairs |
ClinicalTrials.gov Identifier: | NCT00708799 |
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.
Condition | Intervention | Phase |
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Systemic Inflammatory Response Syndrome |
Other: Azithromycin on admission - not enrolled in the RCT |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Efficacy of Macrolide Immunomodulation in Severe Sepsis |
Estimated Enrollment: | 100 |
Study Start Date: | November 2007 |
Estimated Study Completion Date: | November 2010 |
Estimated Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Standard antibiotic therapy +Azithromycin 500 mg intravenously daily for 5 days
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Other: Azithromycin on admission - not enrolled in the RCT
One dose of azithromycin prior to inclusion to the RCT
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2: No Intervention
Standard antibiotic therapy
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In recent studies, the significant effects of macrolide antibiotics (azithromycin) on immune response, unrelated to their anti-microbial properties, have been appreciated. . Clinical trials of macrolides added to -lactams in bacteremic Streptococcus pneumoniae community-acquired pneumonia (CAP) have consistently demonstrated an absolute risk reduction in mortality of 15% in most populations. Several cytokines including tumor necrosis factor (TNF ) interleukin (IL) -1 and IL-8 which are generally proinflammatory and IL-6 and IL-10, which tend to be anti-inflammatory have been associated with sepsis. TNF is a cytokine that for a number of reasons is thought to play a central role in the pathogenesis of sepsis and septic shock.TNF concentrations are increased during clinical and experimental sepsis and increasing concentrations and especially persistence of high concentrations of TNF during sepsis are associated with decreased survival.Therefore, our primary aim 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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
1.Subject, or legal representative, has given written informed consent.
2.18 years of age or older.
3.SIRS is defined as two or more of:
White blood cell count > 12.000/mm3; < 4000/mm3; or > 10% immature (band) forms.
4.Presence of a suspected or proven infection. Patients with suspected infection must have evidence of an infection, such as white blood cells in a normally sterile body fluid, perforated viscus, chest x-ray consistent with pneumonia and associated with purulent sputum production, or a clinical syndrome associated with a high probability of infection (for example, purpura fulminans or ascending cholangitis).
5.Presence of one or more sepsis-associated organ failure. The onset of the first sepsis-associated organ failure must occur within the 48-hour period immediately preceding initiation of study drug infusion. A patient must have an organ failure attributable to the sepsis episode. The organ failure must be newly developed and not explained by underlying disease processes or by effects of concomitant therapy.
Adequate fluid resuscitation or adequate intravascular volume is defined as either pulmonary arterial wedge pressure 12 mm Hg or central venous pressure 8 mm Hg. Vasopressors is defined as dopamine 5 g/kg/min or any dose of norepinephrine, epinephrine, or phenylephrine. Dobutamine is not considered a vasopressor.
Exclusion Criteria:
Immunosuppression as defined by:
Contact: Maria I Velez, MD | (210) 913-0828 | maria.velez@va.gov |
Contact: Timothy Houlihan, RN | (210) 807-0674 ext 14549 | houlihan@uthscsa.edu |
United States, Texas | |
VA South Texas Health Care System | Recruiting |
San Antonio, Texas, United States, 78229 | |
Contact: Maria I Velez, MD 210-913-0828 maria.velez@va.gov | |
Contact: Marcos I Restrepo, MD BA (210) 815-7511 ext 15443 marcos.restrepo@va.gov | |
Principal Investigator: Marcos I. Restrepo, MD BA |
Principal Investigator: | Marcos I. Restrepo, MD BA | VA South Texas Health Care System |
Responsible Party: | Department of Veterans Affairs ( Restrepo, Marcos - Principal Investigator ) |
Study ID Numbers: | VISN 17-001, UHS#20151 |
Study First Received: | June 27, 2008 |
Last Updated: | December 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00708799 |
Health Authority: | United States: Federal Government |
Systemic Inflammatory Response Syndrome Sepsis Shock Azithromycin Inflammation |
Anti-Infective Agents Anti-Bacterial Agents Pathologic Processes Disease |
Therapeutic Uses Syndrome Infection Pharmacologic Actions |