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

NCT01917461 | Completed

• 1 other identifier: MM-1001-BV
• Study Type: observational
• Target: 1,001
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

LRTI; UTI; Gastroenteritis; Systemic Infections/Bacteremia/Meningitis; Fever Without Source

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• The sensitivity and specificity of individual biomarkers 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

  0-10 days after the initiation of symptoms

Eligibility Criteria

• Age: 1 Month+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• MeMed Diagnostics Ltd.: lead

Study Sites (2)

Hillel Yaffe Hospital

Hadera, Israel, 38100, Israel

Location

Bnei Zion Hospital

Haifa, Israel, 31048, Israel

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples Nasopharyngeal samples

MeSH Terms

Conditions

Gastroenteritis; Toxemia

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Infections

Study Officials

• Kfir Oved, Dr.

  MeMed Diagnostics Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2013
• First Posted: August 6, 2013
• Study Start: September 1, 2010
• Primary Completion: December 1, 2013
• Study Completion: September 1, 2014
• Last Updated: March 8, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share

Locations

IL (2)