Sepsis

Programs + Services

Surgical Critical Care

The Division of Surgical Critical Care at Tufts MC in Boston provides post-surgical care for patients in our Surgical Intensive Care Unit (SICU).
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Research + Clinical Trials

Salivary Profiling in Infants Treated for Suspected Sepsis: The SPITSS Study

The goal of this study is to develop a faster, safer, and more accurate method for determining if a newborn has an infection. This study involves analyzing saliva for markers of infection and inflammation known as cytokines. We will analyze infant’s saliva repeatedly for inflammatory biomarkers within the first 36 hours of their standard of care treatment. We hypothesize that levels of these cytokines will more quickly predict which babies are truly infected and which babies are not compared to the blood test currently being used.

The aims of the study are:

• Aim 1: Develop a predictive model of neonatal infection based pon the expression profile of six salivary inflammatory biomarkers (C-reactive protein/CRP, procalcitonin/PCT, tumor necrosis factor-alpha/TNF-α, interleukin (IL) 1-beta/IL1β, IL6, and IL8, within the first 36 hours of treatment.
• Aim 2: Validate the predictive model of neonatal infection developed in Aim 1 on an external cohort of newborns.
• Aim 3: Establish normative salivary reference ranges of the inflammatory biomarkers across varying gestational ages and weights and assess the potential of these biomarkers to predict other neonatal morbidities.

Phase 1b/2a, Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Escalation Study of the Safety, Tolerability, and Efficacy of Intravenous AP-SA02 as an Adjunct to Best Available Antibiotic Therapy Compared to Best Available Antibiotic Therapy Alone for the Treatment of Adults With Bacteremia Due to Staphylococcus aureus.

This study is to evaluate Safety & Tolerability of multiple doses of an experimental i.v. medication (called AP-SA02) in Phase 1b and to evaluate Efficacy, Safety & Tolerability of multiple doses of the same experimental medication in Phase 2a, as compared to Placebo in patients with certain bacterial infection (bacteria named Staphylococcus aureus) of your blood stream. The experimental drug or Placebo will be given in addition to any treatment given for the Blood stream infection by Staphylococcus aureus.
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