Early Targeted Antibiotic Therapy in Patients With Sepsis

Sepsis Clinical Trial

Official title:

Efficacy of Early Targeted Antibiotic Therapy in Patients With Sepsis and Septic Shock

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05459389
• Other study ID #: Early Antibiotic in Sepsis
• Status: Completed
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: September 1, 2023

Study information

• Verified date: September 2023
• Source: Damanhour University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: September 1, 2023
• Est. primary completion date: August 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Male and female patients 18 years or older

2. A definite diagnosis of sepsis or septic shock according to the definition of the 2016 SCCM/ESICM task force.

3. Patients at risk for carbapenemase producing organisms

Exclusion Criteria:

1. Pregnant and lactating women

2. hematological disorders (e.g., leukemia, myelodysplastic syndrome, neoplastic metastases to bone marrow),

3. life-threatening diseases (e.g., malignant solid tumors), acquired immunodeficiency syndrome.

4. Lethal traumatic injury

5. Acute Physiologic Assessment and Chronic Health Evaluation II (APACHE II) score =34 (due to high predicted mortality of 80%)

6. Primary fungal or viral infections

Related Conditions & MeSH terms

• Sepsis
• Toxemia

Intervention

Other:
• targeted antibiotics therapy
targeted antibiotics therapy guided by resistance genotyping (n=24)

Locations

Country	Name	City	State
Egypt	Rehab Hussein Werida	Damanhur	Elbehairah

Sponsors (1)

Lead Sponsor	Collaborator
Rehab Werida

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

Bhattacharyya RP, Bandyopadhyay N, Ma P, Son SS, Liu J, He LL, Wu L, Khafizov R, Boykin R, Cerqueira GC, Pironti A, Rudy RF, Patel MM, Yang R, Skerry J, Nazarian E, Musser KA, Taylor J, Pierce VM, Earl AM, Cosimi LA, Shoresh N, Beechem J, Livny J, Hung DT — View Citation

Martinez ML, Plata-Menchaca EP, Ruiz-Rodriguez JC, Ferrer R. An approach to antibiotic treatment in patients with sepsis. J Thorac Dis. 2020 Mar;12(3):1007-1021. doi: 10.21037/jtd.2020.01.47. — View Citation

Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sirtuin1 (ng/ml)	Levels of Sirtuin1 will be detected using ELISA kits as prescribed by manufacturer.	5 days
Primary	SOFA (score)	SOFA score (?SOFA) which will be calculated by subtracting the final SOFA score at 5 days from the corresponding initial value at enrollment.	5 days
Secondary	mortality rates (%)	number of dead patients.	5 days
Secondary	ventilator free days (days)	count of days free from ventilator,	5 days
Secondary	length of icu stay (Days)	count of days in ICU	5 days