Observational, Prospective Clinical Study to Evaluate Biomarkers as Indicators of Acute Bacterial or Viral Infections (CURIOSITY)

Observational, Prospective Study to Evaluate Biomarkers as Indicators of Bacterial or Viral Infection During Acute Infectious Diseases

This is an observational prospective study of an in-vitro diagnostic (IVD) assay planned to enroll 632 subjects. The study will be conducted in two stages: Stage A is aimed at identifying individual biomarkers and constructing a multi-parametric diagnostic model, whereas Stage B is aimed at testing the multi-parametric diagnostic model using a fresh cohort of patients.

A collection of clinical, radiological and laboratory data will be gathered in order to establish a final diagnosis. Blood samples will be analyzed and the levels of approximately 700 and 250,000 biomarkers will be determined using immunoassays and molecular measurements respectively.

A final diagnosis will be determined based on a majority decision of a panel of three or more independent physicians. Based on the final diagnosis, the accuracy of individual biomarkers and combined sets of biomarkers for differentiating between distinct groups of patients will be evaluated.

Study Overview

• Status: Completed
• Conditions: Gastroenteritis; UTI; LRTI; Fever Without Source; Systemic Infections/Bacteremia/Meningitis

• Study Type: Observational
• Enrollment (Actual): 1001

Contacts and Locations

Study Locations

• Israel
  • Hadera, Israel, 38100
    • Hillel Yaffe Hospital
  • Haifa, Israel, 31048
    • Bnei Zion Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Eligible subjects aged one month of age and older from both genders that attend the hospital or the emergency room (ER) due to a suspected acute infectious disease or due to a non-infectious disease (e.g. Trauma).

Description

Inclusion Criteria:

Patients who are at least one month old and are willing (either the subject or his legal guardian) to sign an informed consent will be eligible for inclusion. For the infectious and non-infectious disease groups, additional inclusion criteria have to be met. These will include:

In the Infectious disease group:

• Peak fever >37.5°C (99.5°F)
• Clinical suspicion of an acute infectious disease
• Symptoms duration ≤ 12 days

In the Non-infectious disease control group:

- A non-infectious disease or healthy individuals

Exclusion Criteria:

Patients who will meet one or more of the following criteria will be excluded from the study:

• Evidence of another episode of acute infectious disease in the last two weeks
• Diagnosed congenital immune deficiency (CID)
• Current treatment with immunosuppressive therapy such as: Active chemotherapy,Post-transplant drugs,High dose steroids (>1 mg/kg/day prednisone or equivalent).
• Active radiotherapy
• Immune-modulating/suppressive drugs including monoclonal antibodies, intravenous immunoglobulin (IVIG), cyclosporine, and anti-TNF agents
• Current treatment with immune stimulants such as: Interleukin (IL)-2, Granulocyte-Monocytes/Granulocyte colony-stimulating factor (GM/G-CSF),Interferon.
• An active hematological malignancy
• A diagnosis of myelodysplastic syndrome or myeloproliferative disease
• A proven or suspected human immunodeficiency virus (HIV)-1, hepatitis B virus (HBV), or hepatitis C virus (HCV) infection

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The sensitivity and specificity of a multi-parametric diagnostic assay in differentiating between bacterial and viral etiology in patients with an acute infectious disease	We will evaluate the sensitivity and specificity of a multi-parametric diagnostic model, incorporating up to five different blood bio-markers in differentiating between bacterial and viral etiology in patients with an acute infectious disease.	0-10 days after the initiation of symptoms

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The sensitivity and specificity of individual biomarkers in differentiating between bacterial and viral etiology in patients with an acute infectious disease	We will evaluate the sensitivity and specificity of individual bio-markers in differentiating between bacterial and viral etiology in patients with an acute infectious disease.	0-10 days after the initiation of symptoms
The sensitivity and specificity of a multi-parametric assay in differentiating between mixed (bacterial and viral co-infection) and pure viral infections in patients with an acute infectious disease	We will evaluate the sensitivity and specificity of a multi-parametric diagnostic assay incorporating up to five different blood bio-markers, in differentiating between mixed infection(bacterial and viral co-infection) and pure viral infection in patients with an acute infectious disease.	0-10 days after the initiation of symptoms

Collaborators and Investigators

• Sponsor: MeMed Diagnostics Ltd.
• Investigators: Study Director: Kfir Oved, Dr., MeMed Diagnostics Ltd.

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: July 31, 2013
• First Submitted That Met QC Criteria: August 4, 2013
• First Posted (Estimate): August 6, 2013

Study Record Updates

• Last Update Posted (Estimate): March 8, 2016
• Last Update Submitted That Met QC Criteria: March 6, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Central Nervous System Diseases; Nervous System Diseases; Systemic Inflammatory Response Syndrome; Inflammation; Disease Attributes; Gastrointestinal Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Sepsis; Infections; Communicable Diseases; Virus Diseases; Bacteremia; Gastroenteritis; Meningitis
• Other Study ID Numbers: MM-1001-BV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No