Early Targeted Antibiotic Therapy in Patients With Sepsis
Condition: Sepsis
MeSH terms: Sepsis; Toxemia
Study type: Interventional

Summary: 
      The aim of this study is to assess the efficacy of early targeted antibiotic therapy in
      patients with sepsis and septic shock using the new biomarker Sirtuin 1 and PCR for bacterial
      resistance detection.

      The primary outcome is change in SOFA score (ΔSOFA) which will be calculated by subtracting
      the final SOFA score and sirtuin 1 level at 5 days from the corresponding initial value at
      enrollment.

      Secondary outcomes included mortality rates, ventilator free days and length of icu stay.
    

Detailed description: 
      -  A prospective, single-center, open labeled, randomized interventional study

        -  Patients will be recruited from a private hospital in Alexandria

        -  Approval will be obtained from Research Ethics Committee of Faculty of Pharmacy,
           Damanhour University

        -  Fourty eight critically ill patients, with sepsis and septic shock according to the 2016
           third international consensus definitions, will be included

        -  Patients with risk for Carbapenemase producing organisms:

             -  Use of broad spectrum cephalosporins and/or carbapenems within the past three
                months

             -  Polytrauma

             -  Diabetes

             -  Malignancy

             -  Organ transplantation

             -  Mechanical ventilation

             -  Indwelling urinary or venous catheters

             -  Overall poor functional status or severe illness

             -  Residence in a long-term care facility(18-28).

        -  The baseline characteristics of the patients will be collected at the time of
           enrollment. The collected data included age, sex, ratio of septic shock to sepsis, ratio
           of ventilated to non-ventilated patients, source of infection, vital signs, laboratory
           data, arterial blood gas (ABG), APACHE II score, Glasgow Coma Scale score, and SOFA
           scores. The level of Procalcitonin (PCT) and Sirtuin-1 will also be measured at this
           time(29).

        -  Patients will be randomly allocated to antibiotic regimen guided by conventional culture
           technique (n=24) or targeted antibiotics therapy guided by resistance genotyping (n=24)
           (29, 30).

        -  Levels of Sirtuin1 will be detected using ELISA kits as prescribed by manufacturer.

        -  Traditional diagnostic microbiology techniques relying on the growth of organisms on
           appropriate culture media (Control group).

        -  Qualitative Multiplex pcr test will be used for rapid detection of carbapenemases genes
           (Intervention group)

        -  Statistical tests appropriate to the study will be conducted to evaluate significance of
           results

        -  Results, conclusion, discussion and recommendations will be given.
    

Intervention name(s): targeted antibiotics therapy
Intervention type(s): Other
Intervention description(s): targeted antibiotics therapy guided by resistance genotyping (n=24)
Other intervention name(s): genotyping
Intervention MeSH terms: Anti-Bacterial Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients will be randomly allocated to antibiotic regimen guided by conventional culture technique (n=24) or targeted antibiotics therapy guided by resistance genotyping (n=24)
Masking: None (Open Label)
Primary purpose: Treatment