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Early Targeted Antibiotic Therapy in Patients With Sepsis

Sponsor
Rehab Werida (Other)
Overall Status
Recruiting
CT.gov ID
NCT05459389
Collaborator
(none)
48
Enrollment
1
Location
2
Arms
12.9
Anticipated Duration (Months)
3.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: targeted antibiotics therapy
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
48 participants
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)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
Official Title:
Efficacy of Early Targeted Antibiotic Therapy in Patients With Sepsis and Septic Shock
Actual Study Start Date :
May 1, 2022
Anticipated Primary Completion Date :
May 30, 2023
Anticipated Study Completion Date :
May 30, 2023

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Group A

antibiotic regimen guided by conventional culture technique (n=24)
Experimental: Group B

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

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Sirtuin1 (ng/ml) [5 days]

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

    2. SOFA (score) [5 days]

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

    Secondary Outcome Measures

    1. mortality rates (%) [5 days]

      number of dead patients.

    2. ventilator free days (days) [5 days]

      count of days free from ventilator,

    3. length of icu stay (Days) [5 days]

      count of days in ICU

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Rehab Hussein Werida Damanhūr Elbehairah Egypt 31527

    Sponsors and Collaborators

    • Rehab Werida

    Investigators

    • Study Director: Rehab H Werida, Ass. Prof., Damanhour University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Rehab Werida, Associate Professor, Damanhour University
    ClinicalTrials.gov Identifier:
    NCT05459389
    Other Study ID Numbers:
    • Early Antibiotic in Sepsis
    First Posted:
    Jul 15, 2022
    Last Update Posted:
    Aug 15, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Sepsis
    Toxemia
    Anti-Bacterial Agents

    Study Results

    No Results Posted as of Aug 15, 2022