Sepsis Clinical Trial - Early Targeted Antibiotic Therapy in Patients With

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05459389
Study type	Interventional
Source	Damanhour University
Contact
Status	Completed
Phase	N/A
Start date	May 1, 2022
Completion date	September 1, 2023

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See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Early Targeted Antibiotic Therapy in Patients With Sepsis

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms