Lower Respiratory Tract InfectionNCT05762302
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)
A study testing MeMed BV test in people with Lower Respiratory Tract Infection, run by MeMed Diagnostics Ltd. at 10 sites in 2 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Lower Respiratory Tract Infection
- What is being tested?
- MeMed BV test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,316 participants
- Where
- 10 sitesin 2 countries
- Study dates
- 31 Jan 2023to 28 Feb 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
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- 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
Trial locations and contacts
10 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
10 sites in 2 countries
United States8 sites, 8 recruiting
- Recruiting
Maimonides Medical Center
Brooklyn, New York, 11219
Sergey Motov, Dr., 1-718-283-7212, smotov@maimonidesmed.org
Sergey Motov, Dr.
- Recruiting
Medical University South Carolina
Charleston, South Carolina, 29425
Amihya Brock, 843-792-7944, brockami@musc.edu
Gary Headden, MD
- Recruiting
UT Southwestern Medical Center
Dallas, Texas, 75390
Katherine Martin, 214-648-2147, Riley.Martin@UTSouthwestern.edu
- Recruiting
University of Florida-Jacksonville
Jacksonville, Florida, 32209
Taylor Munson, 904-244-8605, Taylor.Munson@jax.ufl.edu
- Recruiting
University of Kansas Medical Center
Kansas City, Kansas, 66160
Lucas Lemar, 913.588.3580, llemar@kumc.edu
Chad Cannon, MD
- Recruiting
MCW
Milwaukee, Wisconsin, 53226
Tom Aufderheide, MD, 414-805-6493, jlabinski@mcw.edu
- Recruiting
Philadelphia Thomas Jefferson ED
Philadelphia, Pennsylvania, 19107
Nicole Renzi, 215-955-2471, nicole.renzi@jefferson.edu
- Recruiting
Stony Brook University Hospital
Stony Brook, New York, 11794
Maria Taylor, 631-444-8345, Maria.Taylor@stonybrookmedicine.edu
Adam Singer, MD
Israel2 sites, 2 recruiting
- Recruiting
Carmel Medical Center
Haifa, North
Salim Halabi, Dr., 048250655, SalimHa@clalit.org.il
Salim Halabi, Dr.
- Not yet recruiting
Lin Medical Center
Haifa
Husein Dr.Darawsha, 0542412979, HusinDa@clalit.org.il
About this study
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)
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.
Read the 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.
- Conditions
- Lower Respiratory Tract Infection
- Being tested
- MeMed BV test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MeMed BV testDiagnostic test
Following the MeMed BV test result, the clinician will decide whether or not to prescribe an antibiotic for your condition
| Study group | Role | What they receive |
|---|---|---|
| Adults with suspected Lower Respiratory Track Infection (LRTI)- The MeMed BV arm | Experimental | ED and urgent care center patients over the age of 18 years , with clinical suspicion of Lower Respiratory Track Infection. clinician will receive the BV result, this will include a recommendation regarding antibiotic treatment. A telephone FU call will be done at 28 (+/- 3) days after the day of consent to complete a short questionnaire regarding your current illness Receives: Diagnostic Test: MeMed BV test |
| Adults with suspected Lower Respiratory Track Infection (LRTI)- The control arm | No intervention | ED and urgent care center patients over the age of 18 years , with clinical suspicion of Lower Respiratory Track Infection. clinician will not receive the BV result, and will treat according to standard of care. A telephone FU call will be done at 28 (+/- 3) days after the day of consent to complete a short questionnaire regarding your current illness |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Primary outcome is total antibiotic prescription in the ED/UCC in the BV and control arms, defined as antibiotic initiation by the initial ED/UCC clinician (reached if the patient received antibiotics during ED/UCC visit).
Measured: Through study completion, an average of 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2023
- Study start31 Jan 2023
- Primary completion1 Feb 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Lower Respiratory Tract InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 1,316 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MeMed Diagnostics Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05762302
- Sponsor's protocol ID
- MMD013RCT
- Status last verified
- Jan 2026
- First submitted
- 13 Feb 2023
- Last updated
- 9 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
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.
PubMed 35065702Prestinaci 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.
PubMed 26343252Jourdan 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.
PubMed 31993070Lovegrove 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.
PubMed 30137509Tamma 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.
PubMed 28604925Nelson 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.
PubMed 33512523Cassini 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 population-level modelling analysis. Lancet Infect Dis. 2019 Jan;19(1):56-66. doi: 10.1016/S1473-3099(18)30605-4. Epub 2018 Nov 5.
PubMed 30409683Fendrick 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.
PubMed 12588210Bartlett JG. Clinical practice. Antibiotic-associated diarrhea. N Engl J Med. 2002 Jan 31;346(5):334-9. doi: 10.1056/NEJMcp011603. No abstract available.
PubMed 11821511Giannelli FR. Antibiotic-associated diarrhea. JAAPA. 2017 Oct;30(10):46-47. doi: 10.1097/01.JAA.0000524721.01579.c9. No abstract available.
PubMed 28953024Collins AM, Johnstone CM, Gritzfeld JF, Banyard A, Hancock CA, Wright AD, Macfarlane L, Ferreira DM, Gordon SB. Pneumococcal Colonization Rates in Patients Admitted to a United Kingdom Hospital with Lower Respiratory Tract Infection: a Prospective Case-Control Study. J Clin Microbiol. 2016 Apr;54(4):944-9. doi: 10.1128/JCM.02008-15. Epub 2016 Jan 20.
PubMed 26791364Lim YK, Kweon OJ, Kim HR, Kim TH, Lee MK. Impact of bacterial and viral coinfection in community-acquired pneumonia in adults. Diagn Microbiol Infect Dis. 2019 May;94(1):50-54. doi: 10.1016/j.diagmicrobio.2018.11.014. Epub 2018 Nov 24.
PubMed 30578007Rao S, Lamb MM, Moss A, Mistry RD, Grice K, Ahmed W, Santos-Cantu D, Kitchen E, Patel C, Ferrari I, Dominguez SR. Effect of Rapid Respiratory Virus Testing on Antibiotic Prescribing Among Children Presenting to the Emergency Department With Acute Respiratory Illness: A Randomized Clinical Trial. JAMA Netw Open. 2021 Jun 1;4(6):e2111836. doi: 10.1001/jamanetworkopen.2021.11836.
PubMed 34086034Herberg JA, Kaforou M, Gormley S, Sumner ER, Patel S, Jones KD, Paulus S, Fink C, Martinon-Torres F, Montana G, Wright VJ, Levin M. Transcriptomic profiling in childhood H1N1/09 influenza reveals reduced expression of protein synthesis genes. J Infect Dis. 2013 Nov 15;208(10):1664-8. doi: 10.1093/infdis/jit348. Epub 2013 Jul 29.
PubMed 23901082Wong JG, Aung AH, Lian W, Lye DC, Ooi CK, Chow A. Risk prediction models to guide antibiotic prescribing: a study on adult patients with uncomplicated upper respiratory tract infections in an emergency department. Antimicrob Resist Infect Control. 2020 Nov 2;9(1):171. doi: 10.1186/s13756-020-00825-3.
PubMed 33138859