SepsisPCTCRPNCT04049565
CRP Versus PCT as Bio-markers for Sepsis and in Guiding Antibiotics in Critically Ill Patients
An observational study of Sepsis and Morality, run by Beni-Suef University at 1 site in Egypt.
Trial summary
Sepsis is a life threatening organ dysfunction caused by infection. Severe sepsis is expected to rise due to resistance to antibiotics. Inappropriate use of antibiotics in the ICU leads to adverse drug reaction and bacterial resistance. Read more about this study
- Who is it for?
- Ages 18 to 69 years
- What is being tested?
- Procalcitonin biomarker and CRP biomarker
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2018to 15 Mar 2019
- Phase
- Observational
- 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 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with sepsis or septic shock
Who may be able to join
- Age >18 and less than 70
- Patients with sepsis or septic shock who received their first doses of antibiotics no longer than 24 h before inclusion into the study
Who cannot join
- - Elderly (defined as older than 70).
- Pregnancy and lactation
- Immunocompromised patients or who had high doses of corticosteroids
- Patients with chronic organ failure
- Infections that required long-term treatment, regardless of the etiologic agent (e.g., bacterial endocarditis).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Procalcitonin Versus C-Reactive Protein for the Guidance of Antibiotic Therapy in Critically Ill Septic Patients
Sepsis is a life threatening organ dysfunction caused by infection. Severe sepsis is expected to rise due to resistance to antibiotics. Inappropriate use of antibiotics in the ICU leads to adverse drug reaction and bacterial resistance. Using biomarkers for infection as PCT and CRP are useful in diagnosing infection and duration of therapy. CRP based protocol will be compared to PCT based protocol for reducing the length of stay and reduction of antibiotic use in critically ill patients.
Read the detailed description
Sepsis is a syndrome of physiologic, pathologic, and biochemical abnormalities induced by infection. It is defined as life-threatening organ dysfunction caused by a dysregulated host response to infection. It is a major public health concern, accounting for more than $20 billion (5.2%) of total US hospital costs in 2011. Not only is sepsis expensive and prevalent, but it is a major cause of mortality and critical illness worldwide. Moreover, cases of severe sepsis are expected to rise in the future for several reasons, including: Increased awareness and sensitivity for the diagnosis; increasing numbers of immunocompromised patients; wider use of invasive procedures; more resistant microorganisms; and old aging population.
Use of appropriate antibiotics in the intensive care unit (ICU) is a major challenge. Studies have shown that up to 50% of antibiotics prescribed in hospital settings are either unnecessary or inappropriate, contributing to increasing rates of resistant organisms, increases in adverse drug reactions, overall length of stay (LOS) and mortality. In addition, in critically ill patients, a long duration of treatment with antibiotics is associated with the development of antimicrobial resistance. Moreover, Sepsis and Systemic Inflammatory Response Syndrome (SIRS) SIRS can closely mimic one another and present a diagnostic challenge. So, determination of the presence or absence of bacterial infection is important to guide appropriate therapy and reduce antibiotic exposure. For microorganism detection, culture sensitivity is used though it has some drawbacks as time consuming, sometimes misleading with negative or positive reports and also they don't give information about the onset of organ dysfunction. Accordingly, it is important to differentiate culture negative sepsis patients from those with noninfectious SIRS, as these disease conditions require different therapeutic regimens. Due to these drawbacks of culture, researchers tried to depend on other more specific blood markers.
Biomarkers of infection, namely C-reactive protein and procalcitonin (PCT) have been shown to be useful in the diagnosis of infection as well as in the assessment of its response to antibiotic therapy. C-reactive protein variations overtime appears to have a good performance for the diagnosis of infection. Procalcitonin shows a better correlation with clinical severity.
Despite being used routinely in several intensive care services as an auxiliary criterion for decisions regarding antibiotic therapy, no C- reactive protein based protocol has been tested in clinical trials to guide the reduction of antibiotic use in patients with sepsis until 2012. In 2013 Oliveira et al. compared a protocol based on serum PCT levels versus a protocol based on serum C-reactive protein levels for reducing the duration of antibiotic treatment in critically ill patients presenting with severe sepsis or septic shock. The latter study showed that C-reactive protein was as useful as procalcitonin in reducing antibiotic use in a predominantly medical population of septic patients, causing no apparent harm.
- Being tested
- Procalcitonin biomarker and CRP biomarker
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Procalcitonin biomarker and CRP biomarkerDiagnostic test
collecting blood samples to measure serum CRP and Procalcitonin
| Study group | Role | What they receive |
|---|---|---|
| Procalcitonin | septic patients who will receive Procalcitonin Receives: Diagnostic Test: Procalcitonin biomarker and CRP biomarker | |
| C-Reactive Protein | septic patients who will receive C-Reactive ptotein Receives: Diagnostic Test: Procalcitonin biomarker and CRP biomarker |
What is being measured
The primary outcome is the main question the study is designed to answer.
compare between CRP and procalcitonin in guiding antibiotic therapy in sepsis and septic shock
measurement of the accuracy and validity of CRP and PCT as biomarkers of sepsis
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2019
- Study start1 Oct 2018
- Primary completion1 Feb 2019
- Study completion15 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Beni-Suef UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Walid Ahmed Ali, Beni-Suef University
- Investigators
- Abdelrahman Dr ElNaggar, Prof, Principal investigator, study official is dead
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04049565
- Sponsor's protocol ID
- PCTCRP
- Acronym
- PCTCRP
- Status last verified
- Feb 2020
- First submitted
- 6 Aug 2019
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Procalcitonin Versus C-Reactive Protein for the Guidance of Antibiotic Therapy in Critically Ill Septic Patients
- ClinicalTrials.gov ID
- NCT04049565
- Acronym / sponsor ID
- PCTCRP / PCTCRP
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 1 Feb 2019 (actual)
- Study completion
- 15 Mar 2019 (actual)
- First posted
- 8 Aug 2019 (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.
Sepsis is a life threatening organ dysfunction caused by infection. Severe sepsis is expected to rise due to resistance to antibiotics. Inappropriate use of antibiotics in the ICU leads to adverse drug reaction and bacterial resistance. Using biomarkers for infection as PCT and CRP are useful in diagnosing infection and duration of therapy. CRP based protocol will be compared to PCT based protocol for reducing the length of stay and reduction of antibiotic use in critically ill patients.
Detailed description
Sepsis is a syndrome of physiologic, pathologic, and biochemical abnormalities induced by infection. It is defined as life-threatening organ dysfunction caused by a dysregulated host response to infection. It is a major public health concern, accounting for more than $20 billion (5.2%) of total US hospital costs in 2011. Not only is sepsis expensive and prevalent, but it is a major cause of mortality and critical illness worldwide. Moreover, cases of severe sepsis are expected to rise in the future for several reasons, including: Increased awareness and sensitivity for the diagnosis; increasing numbers of immunocompromised patients; wider use of invasive procedures; more resistant microorganisms; and old aging population.
Use of appropriate antibiotics in the intensive care unit (ICU) is a major challenge. Studies have shown that up to 50% of antibiotics prescribed in hospital settings are either unnecessary or inappropriate, contributing to increasing rates of resistant organisms, increases in adverse drug reactions, overall length of stay (LOS) and mortality. In addition, in critically ill patients, a long duration of treatment with antibiotics is associated with the development of antimicrobial resistance. Moreover, Sepsis and Systemic Inflammatory Response Syndrome (SIRS) SIRS can closely mimic one another and present a diagnostic challenge. So, determination of the presence or absence of bacterial infection is important to guide appropriate therapy and reduce antibiotic exposure. For microorganism detection, culture sensitivity is used though it has some drawbacks as time consuming, sometimes misleading with negative or positive reports and also they don't give information about the onset of organ dysfunction. Accordingly, it is important to differentiate culture negative sepsis patients from those with noninfectious SIRS, as these disease conditions require different therapeutic regimens. Due to these drawbacks of culture, researchers tried to depend on other more specific blood markers.
Biomarkers of infection, namely C-reactive protein and procalcitonin (PCT) have been shown to be useful in the diagnosis of infection as well as in the assessment of its response to antibiotic therapy. C-reactive protein variations overtime appears to have a good performance for the diagnosis of infection. Procalcitonin shows a better correlation with clinical severity.
Despite being used routinely in several intensive care services as an auxiliary criterion for decisions regarding antibiotic therapy, no C- reactive protein based protocol has been tested in clinical trials to guide the reduction of antibiotic use in patients with sepsis until 2012. In 2013 Oliveira et al. compared a protocol based on serum PCT levels versus a protocol based on serum C-reactive protein levels for reducing the duration of antibiotic treatment in critically ill patients presenting with severe sepsis or septic shock. The latter study showed that C-reactive protein was as useful as procalcitonin in reducing antibiotic use in a predominantly medical population of septic patients, causing no apparent harm.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Procalcitonin | – | Diagnostic Test: Procalcitonin biomarker and CRP biomarkerseptic patients who will receive Procalcitonin |
| C-Reactive Protein | – | Diagnostic Test: Procalcitonin biomarker and CRP biomarkerseptic patients who will receive C-Reactive ptotein |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with sepsis or septic shock
Key inclusion criteria (2 listed)
- Age >18 and less than 70
- Patients with sepsis or septic shock who received their first doses of antibiotics no longer than 24 h before inclusion into the study
Key exclusion criteria (5 listed)
- - Elderly (defined as older than 70).
- Pregnancy and lactation
- Immunocompromised patients or who had high doses of corticosteroids
- Patients with chronic organ failure
- Infections that required long-term treatment, regardless of the etiologic agent (e.g., bacterial endocarditis).
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 |
|---|---|---|
| Procalcitonin biomarker and CRP biomarkercollecting blood samples to measure serum CRP and Procalcitonin | Diagnostic test | C-Reactive Protein, Procalcitonin |
Primary outcome
compare between CRP and procalcitonin in guiding antibiotic therapy in sepsis and septic shock
Time frame: one year
measurement of the accuracy and validity of CRP and PCT as biomarkers of sepsis
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 5 Feb 2020.
- Individual participant dataSharing planned: No
Related trials for Sepsis
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
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.
Abdelrahman Dr ElNaggar, Prof principal investigator
study official is dead
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Morality, run by Beni-Suef University 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 2 inclusion and 5 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 5 Feb 2020. 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?
compare between CRP and procalcitonin in guiding antibiotic therapy in sepsis and septic shock (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Feb 2020.