Clinical Trials Logo
  1. Home
  2. Other
  3. NCT00708799

Efficacy of Macrolide Immunomodulation in Severe Sepsis.

Systemic Inflammatory Response Syndrome Clinical Trial

Official title:
Efficacy of Macrolide Immunomodulation in Severe Sepsis

Clinical Trial 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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

  • Sepsis
  • Systemic Inflammatory Response Syndrome
Clinical Trial Details
NCT number NCT00708799
Study type Interventional
Source VA Office of Research and Development
Contact
Status Terminated
Phase Phase 2
Start date November 2007
Completion date November 2013
View Details
See also
  Status Clinical Trial Phase
Completed NCT02518087 - Increased Adsorption Membranes During Cardiopulmonary Bypass N/A
Completed NCT02902939 - Myeloid-Derived Supressor Cells in Cardiac Surgery Patients N/A
Completed NCT02563652 - Can Biomarkers Aid in the Prediction of Postoperative Pain and Circulatory Instability After Major Abdominal Surgery?
Recruiting NCT01157299 - Hemodynamic Evaluation of Preload Responsiveness in Children by Using PiCCO N/A
Completed NCT01388725 - Comparison the Value of Several Biomarkers of Sepsis N/A
Unknown status NCT00254176 - Cysteine Supplementation in Critically Ill Neonates Phase 2/Phase 3
Not yet recruiting NCT03617796 - Prognostic Value of CD64 Marker for Patients in Intensive Care Unit
Completed NCT03876041 - Evaluation of Corticosteroid in Systemic Inflammatory Response Syndrome Phase 4
Recruiting NCT05608096 - European Registry for Hemadsorption in Sepsis With the Seraph Filter
Completed NCT03314831 - The Role of Myristic Acid in Serum for Early Diagnosis of Sepsis and Comparison With Selected Biomarkers of Sepsis
Completed NCT02568410 - Platelets as Regulators of Inflammation in Cardiac Surgery
Completed NCT01636232 - Vitamin D and Critically Ill Patients N/A
Completed NCT01020409 - INFLACOR - Clinical and Genetic Predictors of Inflammation Related Complications After Heart Surgery Phase 4
Completed NCT04624776 - Steroid Treatment After Resuscitated Out-of-Hospital Cardiac Arrest Phase 2
Recruiting NCT05172739 - Opioid Free Anaesthesia-Analgesia Strategy on Surgical Stress and Immunomodulation in Elective VATS-Lobectomy for NSCLC Phase 4
Recruiting NCT02957175 - Immunophenotyping of Patients With Postoperative SIRS
Completed NCT02320539 - MicroRNA Diagnostics in Subarachnoid Hemorrhage 2 N/A
Completed NCT01708759 - IL8 Monitoring and Its Correlation With 251-gene Polymorphism N/A
Recruiting NCT04580680 - Extracorporeal Blood Purification Therapy in Critically Ill Patients (GlobalARRT)
Recruiting NCT05663216 - Determinants of Vascular Leakage During Systemic Inflammatory Response Syndrome