NCT04049565

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 6, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 8, 2019

Completed
Last Updated

February 5, 2020

Status Verified

February 1, 2020

Enrollment Period

4 months

First QC Date

August 6, 2019

Last Update Submit

February 1, 2020

Conditions

Outcome Measures

Primary Outcomes (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

    one year

Study Arms (2)

Procalcitonin

septic patients who will receive Procalcitonin

Diagnostic Test: Procalcitonin biomarker and CRP biomarker

C-Reactive Protein

septic patients who will receive C-Reactive ptotein

Diagnostic Test: Procalcitonin biomarker and CRP biomarker

Interventions

collecting blood samples to measure serum CRP and Procalcitonin

C-Reactive ProteinProcalcitonin

Eligibility Criteria

Age18 Years - 69 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients with sepsis or septic shock

You may qualify if:

  • Age \>18 and less than 70

You may not qualify if:

  • \- 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University Hospital

Cairo, 11865, Egypt

Location

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Abdelrahman Dr ElNaggar, Prof

    study official is dead

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Pharmacist / Walid Ahmed Ali Abdeltawab

Study Record Dates

First Submitted

August 6, 2019

First Posted

August 8, 2019

Study Start

October 1, 2018

Primary Completion

February 1, 2019

Study Completion

March 15, 2019

Last Updated

February 5, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations