Evaluating a Host-response Based Diagnostic for Distinguishing Between Bacterial and Viral Etiology in Patients With Lower Respiratory Tract Infection (LRTI) (OBSERVER)

MeMed

Status: Completed

Conditions: Acute Bronchitis; Lower Respiratory Tract Infection; Pneumonia; Upper Respiratory Tract Infection; Chronic Obstructive Pulmonary Disease (COPD)

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03011515

MM-1005-OB

Details and patient eligibility

About

The purpose of this study is to validate the diagnostic accuracy of a novel host-response based diagnostic tool for differentiating between bacterial and viral etiologies in adult patients aged 18 years and older with clinical suspicion of lower respiratory tract infections (LRTI)

Enrollment: 583 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients aged 18 years and older who agree (or their legal guardian agree) to sign an informed consent will be eligible for inclusion.

• The LRTI cohorts should also fulfill the following criteria:

  • Peak measured (not tactile, self-reported acceptable) temperature ≥ 37.8°C (100°F) within the last 7 days (AND)
  • Symptoms duration ≤7 days (AND)
  • Clinical suspicion of LRTI or pneumonia

Exclusion criteria

• Oral/intravenous/intramuscular antibiotic treatment of over 48/12/12 hours' duration at time of enrollment (respectively), unless temperature ≥ 37.8°C was measured within the last 2 days

• Another episode of an acute infection during the last 2 weeks

• Congenital immune deficiency (CID)

• A proven or suspected human immunodeficiency virus (HIV)-1, hepatitis B virus (HBV), or hepatitis C virus (HCV) infection

• Active malignancy

• Pregnancy

• Current treatment with immune-suppressive or immune-modulating therapies including without limitations:

  • Use of high dose steroids >1 mg/kg/day prednisone or equivalent in the past two weeks
  • Monoclonal antibodies
  • Intravenous immunoglobulin (IVIG)
  • Cyclosporine, Cyclophosphamide, Tacrolimus
  • Granulocyte/Monocyte colony stimulating factor (G/GM-CSF)
  • Anti-Tumor Necrosis Factor (TNF) agents
  • Interferon (of all kinds)

• Other severe illnesses that affect life expectancy and quality of life such as:

  • Moderate to severe psychomotor retardation
  • Post-transplant patients (including solid organs, allogeneic/autologous stem cell transplantation)
  • Moderate to severe congenital metabolic disorder

Trial design

583 participants in 3 patient groups

LRTI patients

Description:

Patients with suspicion of LRTI, excluding episodes of COPD exacerbations

Non-infectious patients

Description:

Afebrile patients with no apparent infectious disease

LRTI patients with COPD

Description:

Patients with suspicion of LRTI in a sub-group of patients with COPD