Early Targeted Antibiotic Therapy in Patients With Sepsis

NCT05459389 | Completed

• 1 other identifier: Early Antibiotic in Sepsis
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sepsis

Outcome Measures

Primary Outcomes (2)

• Sirtuin1 (ng/ml)

  Levels of Sirtuin1 will be detected using ELISA kits as prescribed by manufacturer.

  5 days

• SOFA (score)

  SOFA score (ΔSOFA) which will be calculated by subtracting the final SOFA score at 5 days from the corresponding initial value at enrollment.

  5 days

Secondary Outcomes (3)

• mortality rates (%)

  5 days

• ventilator free days (days)

  5 days

• length of icu stay (Days)

  5 days

Study Arms (2)

Group A

NO INTERVENTION

antibiotic regimen guided by conventional culture technique (n=24)

Group B

EXPERIMENTAL

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

Other: targeted antibiotics therapy

Interventions

targeted antibiotics therapy OTHER

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

Also known as: genotyping

Group B

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female patients 18 years or older
• A definite diagnosis of sepsis or septic shock according to the definition of the 2016 SCCM/ESICM task force.
• Patients at risk for carbapenemase producing organisms

You may not qualify if:

• Pregnant and lactating women
• hematological disorders (e.g., leukemia, myelodysplastic syndrome, neoplastic metastases to bone marrow),
• life-threatening diseases (e.g., malignant solid tumors), acquired immunodeficiency syndrome.
• Lethal traumatic injury
• Acute Physiologic Assessment and Chronic Health Evaluation II (APACHE II) score ≥34 (due to high predicted mortality of 80%)
• Primary fungal or viral infections

Sponsors & Collaborators

• Rehab Werida: lead

Study Sites (1)

Rehab Hussein Werida

Damanhūr, Elbehairah, 31527, Egypt

Location

Related Publications (3)

• 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.

  PMID: 26903338 BACKGROUND

• 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.

  PMID: 32274170 RESULT

• 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. Simultaneous detection of genotype and phenotype enables rapid and accurate antibiotic susceptibility determination. Nat Med. 2019 Dec;25(12):1858-1864. doi: 10.1038/s41591-019-0650-9. Epub 2019 Nov 25.

  PMID: 31768064 RESULT

MeSH Terms

Conditions

Sepsis

Interventions

Genotype

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Genetic Phenomena

Study Officials

• Rehab H Werida, Ass. Prof.

  Damanhour University

  STUDY DIRECTOR

• Noha Elbassiony

  Damanhour University

  PRINCIPAL INVESTIGATOR

• Eman Momtaz

  Damanhour University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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)

Study Record Dates

• First Submitted: July 12, 2022
• First Posted: July 15, 2022
• Study Start: May 1, 2022
• Primary Completion: August 30, 2023
• Study Completion: September 1, 2023
• Last Updated: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)