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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
Conditions the study is for
Sepsis, Morality
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.

Egypt1 site
  • Cairo University Hospital

    Cairo, 11865

Other trials in Egypt

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.

Conditions
Sepsis, Morality
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 groups in NCT04049565
Study groupRoleWhat they receive
Procalcitoninseptic patients who will receive Procalcitonin
Receives: Diagnostic Test: Procalcitonin biomarker and CRP biomarker
C-Reactive Proteinseptic 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.

  1. 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.

  1. First posted8 Aug 2019
  2. Study start1 Oct 2018
  3. Primary completion1 Feb 2019
  4. Study completion15 Mar 2019

Resources

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)
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

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.

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