SepsisNCT05459389
Early Targeted Antibiotic Therapy in Patients With Sepsis
A study testing targeted antibiotics therapy in people with Sepsis, run by Rehab Werida at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Sepsis
- What is being tested?
- targeted antibiotics therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2022to 1 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Early Targeted Antibiotic Therapy in Patients With Sepsis and Septic Shock
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.
Read the 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.
- Conditions
- Sepsis
- Being tested
- targeted antibiotics therapy
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
targeted antibiotics therapyOther
Also called genotyping
targeted antibiotics therapy guided by resistance genotyping (n=24)
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Other: targeted antibiotics therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sirtuin1 (ng/ml)
Levels of Sirtuin1 will be detected using ELISA kits as prescribed by manufacturer.
Measured: 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.
Measured: 5 days
Secondary outcomes (3)
mortality rates (%)
number of dead patients.
Measured: 5 days
ventilator free days (days)
count of days free from ventilator,
Measured: 5 days
length of icu stay (Days)
count of days in ICU
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2022
- Study start1 May 2022
- Primary completion30 Aug 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rehab Werida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rehab Werida, Damanhour University
- Investigators
- Rehab H Werida, Ass. Prof., Study director, Damanhour UniversityNoha Elbassiony, Principal investigator, Damanhour UniversityEman Momtaz, Principal investigator, Damanhour University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05459389
- Sponsor's protocol ID
- Early Antibiotic in Sepsis
- Status last verified
- Sep 2023
- First submitted
- 12 Jul 2022
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26903338Martinez 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.
PubMed 32274170Bhattacharyya 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.
PubMed 31768064
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Early Targeted Antibiotic Therapy in Patients With Sepsis and Septic Shock
- ClinicalTrials.gov ID
- NCT05459389
- Acronym / sponsor ID
- Early Antibiotic in Sepsis
- Conditions
- Sepsis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Rehab WeridaUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 30 Aug 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 15 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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)
| Arm | Type | Receives |
|---|---|---|
| Group A | No intervention | –antibiotic regimen guided by conventional culture technique (n=24) |
| Group B | Experimental | Other: targeted antibiotics therapytargeted antibiotics therapy guided by resistance genotyping (n=24) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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%)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| targeted antibiotics therapyAlso: genotypingtargeted antibiotics therapy guided by resistance genotyping (n=24) | Other | Group B |
Primary outcome
Sirtuin1 (ng/ml)
Time frame: 5 days
Levels of Sirtuin1 will be detected using ELISA kits as prescribed by manufacturer.
SOFA (score)
Time frame: 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.
3 secondary outcomes
mortality rates (%)
Time frame: 5 days
ventilator free days (days)
Time frame: 5 days
length of icu stay (Days)
Time frame: 5 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Background: PubMed 26903338Singer 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.
- Results publication: PubMed 32274170Martinez 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.
- Results publication: PubMed 31768064Bhattacharyya 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rehab H Werida, Ass. Prof. study director
Damanhour University
Noha Elbassiony principal investigator
Damanhour University
Eman Momtaz principal investigator
Damanhour University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing targeted antibiotics therapy in people with Sepsis, run by Rehab Werida at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sirtuin1 (ng/ml) (time frame: 5 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05459389, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.