Status:
COMPLETED
Establish MeMed BV™ Performance for Differentiating Bacterial From Viral Infection in Suspected Acute Infection Patients (APOLLO STUDY)
Lead Sponsor:
MeMed Diagnostics Ltd.
Conditions:
Acute Infection
Eligibility:
All Genders
90+ years
Brief Summary
Prospective, multi-center, observational, blinded study, enrolling pediatric and adult subjects. Eligible ED\\Urgent care and hospital admitted patients with symptoms consistent with acute bacterial o...
Eligibility Criteria
Inclusion
- Written informed consent must be obtained from the patient or his/her legal guardian. For children under 18 years old, written informed consent from the legal guardian and assent from the patient (depending on the local requirements)
- Over 90 days of age
- Clinical suspicion of acute bacterial or viral infection
- Temperature ≥ 37.8°C (100°F) (any body site, any measurement device, including self-reported) or tactile fever, either of them noted at least once within the last 7 days
- Current disease duration ≤ 7 days
Exclusion
- Another unrelated episode of febrile infection within the past 2 weeks
- Suspicion and/or confirmed diagnosis of infectious gastroenteritis/ colitis
- \>48 hours of oral antibiotic treatment
- \>12 hours of intravenous\\intramuscular antibiotic treatment
- HIV, HBV, or HCV infection (self-declared or known from medical records)
- A proven or suspected infection on presentation with Mycobacterial (e.g. Tuberculosis, MAC), parasitic or fungal (e.g. Candida, Histoplasma, Aspergillus) pathogen
- Active inflammatory disease (e.g. IBD, SLE, JIA, RA, Kawasaki, other vasculitis)
- Major trauma and\\or burns in the last 7 days
- Major surgery in the last 7 days
- Congenital immune deficiency (CID)
- Acquired immune deficiency\\modulation state including:
- Active malignancy
- Current treatment with immune-suppressive or immune-modulating therapies, including without limitations:
- Administration of P.O.\\IV\\IM high dose steroids \>1mg/kg/day prednisone (or equivalent) at some point in the past 10 days or daily continuous use of steroids \> 0.25 mg/kg/day in the past 7 days
- Monoclonal antibodies, anti-TNF agents
- Intravenous immunoglobulin (IVIG)
- Cyclosporine, Cyclophosphamide, Tacrolimus, Azathioprine, Methotrexate
- G/GM-CSF, Interferons
- Post solid organ/bone marrow transplant patients
- Asplenia, sickle cell disease
- Indwelling central venous catheter
- Cystic Fibrosis
- Pregnancy- self reported or medically known
- Other severe illnesses that affect life expectancy and quality of life such as:
- Severe psychomotor retardation
- Congenital metabolic disorder
- End stage renal disease, advanced heart failure (NYHA 3/4), advanced COPD (GOLD 3/4)
Key Trial Info
Start Date :
May 3 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 22 2020
Estimated Enrollment :
1384 Patients enrolled
Trial Details
Trial ID
NCT04690569
Start Date
May 3 2019
End Date
November 22 2020
Last Update
January 5 2021
Active Locations (11)
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1
Johns Hopkins
Baltimore, Maryland, United States, 21218
2
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
3
Maimonides Medical Center
New York, New York, United States, 11219
4
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15260