The Impact of MeMed BV® on Management of Patients With Suspected Lower Respiratory Tract Infections (LRTI) in the Emergency Department (ED) and Urgent Care Center (UCC) ("JUPITER" TRIAL)

Official title

A Multicenter Randomized Controlled Trial to Establish the Impact of MeMed BV® on Management of Patients With Suspected Lower Respiratory Tract Infections (LRTI) in the Emergency Department (ED) and Urgent Care Center (UCC) ("JUPITER" TRIAL)

Overview

This is a Prospective, multi-center study enrolling adults subjects presented to the ED/Urgent care, with symptoms consistent with lower respiratory infection (LRTI). The reason of this study is to demonstrate the MeMed BV can help clinicians make decisions about using antibiotics in patients with lower respiratory track infections and see how it would impact clinical outcomes, antibiotics use, hospitalizations, ED clinicians find ways to improve health and medical care.

Detailed description

There will be a pre-study implementation phase (JUNO trial), in which approximately 250 patients will be recruited. Data obtained for these patients will not be included in the analysis. The purpose of the pre-study implementation phase is to enable the participating clinicians to become familiar with the MeMed BV test. An additional purpose is to test the design and operational assumptions before the subsequent JUPITER trial.

Interventions

• Diagnostic test MeMed BV test
  Following the MeMed BV test result, the clinician will decide whether or not to prescribe an antibiotic for your condition

Primary outcome measures

• To demonstrate MeMed BV® added value on top of standard of care in lowering unwarranted antibiotic prescribing in patients with LRTI in the ED/UCC. [Time frame: Through study completion, an average of 18 months]

Eligibility criteria

Inclusion criteria

• Patients eligible for inclusion are required to fulfill all of the following criteria:
• Written informed consent must be obtained from the patient or his/her legal guardian.
• 18 years of age or older.
• Current disease duration ≤ 7 days.
• Tactile fever or measured temperature ≥ 37.8°C (100°F) (any body site, any measurement device, including self-reported), either of them noted at least once within the last 7 days.
• Clinical suspicion of bacterial or viral LRTI: At least one of the following respiratory signs or symptoms: cough (new or worsening), sputum production, dyspnea/shortness of breath, auscultatory abnormality (e.g. wheezing, rhonchi).
• Clinician intent to prescribe antibiotics based on the currently available data.

Exclusion criteria

Patients fulfilling any of the following criteria are not eligible for inclusion in the infectious cohort:

• Systemic antibiotics within 72 hours prior to enrollment
• Inflammatory disease (e.g., IBD, SLE, Rheumatoid arthritis, Kawasaki, other vasculitis)
• Congenital immune deficiency (CID)
• A proven or suspected infection on presentation with Mycobacterial (e.g., MAC, MABC), parasitic or fungal (e.g., Candida, Histoplasma, Aspergillus) pathogen
• HIV, HBV, or HCV infection (self-declared or known from medical records)
• Major surgery, trauma and\\or burns in the last 7 days
• Pregnancy- self reported or medically confirmed
• Active malignancy - Cancer diagnosed within the previous six months, recurrent, regionally advanced or metastatic cancer, cancer for which treatment had been administered within six months, or hematological cancer that is not in complete remission.
• Patients with severe illnesses that affect life expectancy and quality of life such as end stage renal disease, end stage liver disease or severe COPD.
• Clinician intent to hospitalize patient.
• Patients with suspected concomitant infections (e.g. UTI, cellulitis, gastroenteritis, etc.)
• Active treatment with immune-suppressive or immune-modulating therapies, including without limitations:

Administration of PO\\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

•Considered unsuitable for the study by the study team

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Diagnostic

Study locations

United States · 8 centers

• University of Florida-Jacksonville — Jacksonville
• University of Kansas Medical Center — Kansas City
• Maimonides Medical Center — Brooklyn
• Stony Brook University Hospital — Stony Brook
• Philadelphia Thomas Jefferson ED — Philadelphia
• Medical University South Carolina — Charleston
• UT Southwestern Medical Center — Dallas
• MCW — Milwaukee

Israel · 2 centers

• Carmel Medical Center — Haifa
• Lin Medical Center — Haifa

Publications

• Antimicrobial Resistance Collaborators. Global burden of bacterial antimicrobial resistance in 2019: a systematic analysis. Lancet. 2022 Feb 12;399(10325):629-655. doi: 10.1016/S0140-6736(21)02724-0. Epub 2022 Jan 19. PMID 35065702
• Prestinaci F, Pezzotti P, Pantosti A. Antimicrobial resistance: a global multifaceted phenomenon. Pathog Glob Health. 2015;109(7):309-18. doi: 10.1179/2047773215Y.0000000030. Epub 2015 Sep 7. PMID 26343252
• Jourdan A, Sangha B, Kim E, Nawaz S, Malik V, Vij R, Sekhsaria S. Antibiotic hypersensitivity and adverse reactions: management and implications in clinical practice. Allergy Asthma Clin Immunol. 2020 Jan 21;16:6. doi: 10.1186/s13223-020-0402-x. eCollection 2020. PMID 31993070
• Lovegrove MC, Geller AI, Fleming-Dutra KE, Shehab N, Sapiano MRP, Budnitz DS. US Emergency Department Visits for Adverse Drug Events From Antibiotics in Children, 2011-2015. J Pediatric Infect Dis Soc. 2019 Nov 6;8(5):384-391. doi: 10.1093/jpids/piy066. PMID 30137509
• Tamma PD, Avdic E, Li DX, Dzintars K, Cosgrove SE. Association of Adverse Events With Antibiotic Use in Hospitalized Patients. JAMA Intern Med. 2017 Sep 1;177(9):1308-1315. doi: 10.1001/jamainternmed.2017.1938. PMID 28604925
• Nelson RE, Hatfield KM, Wolford H, Samore MH, Scott RD, Reddy SC, Olubajo B, Paul P, Jernigan JA, Baggs J. National Estimates of Healthcare Costs Associated With Multidrug-Resistant Bacterial Infections Among Hospitalized Patients in the United States. Clin Infect Dis. 2021 Jan 29;72(Suppl 1):S17-S26. doi: 10.1093/cid/ciaa1581. PMID 33512523
• Cassini A, Hogberg LD, Plachouras D, Quattrocchi A, Hoxha A, Simonsen GS, Colomb-Cotinat M, Kretzschmar ME, Devleesschauwer B, Cecchini M, Ouakrim DA, Oliveira TC, Struelens MJ, Suetens C, Monnet DL; Burden of AMR Collaborative Group. Attributable deaths and disability-adjusted life-years caused by infections with antibiotic-resistant bacteria in the EU and the European Economic Area in 2015: a po PMID 30409683
• Fendrick AM, Monto AS, Nightengale B, Sarnes M. The economic burden of non-influenza-related viral respiratory tract infection in the United States. Arch Intern Med. 2003 Feb 24;163(4):487-94. doi: 10.1001/archinte.163.4.487. PMID 12588210

Identifiers

NCT: NCT05762302 · MMD013RCT

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗