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)

Lower Respiratory Tract Infection Clinical 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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05762302
• Other study ID #: MMD013RCT
• Status: Recruiting
• Phase: N/A
• Start date: January 31, 2023
• Est. completion date: February 28, 2025

Study information

• Verified date: May 2024
• Source: MeMed Diagnostics Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 track infections and see how it would impact clinical outcomes, antibiotics use, hospitalizations, ED clinicians find ways to improve health and medical care.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1316
• Est. completion date: February 28, 2025
• Est. primary completion date: February 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

1. Written informed consent must be obtained from the patient or his/her legal guardian.

2. 18 years of age or older.

3. Current disease duration = 7 days.

4. Temperature = 37.8°C (100°F) or tactile fever, noted at least once within the last 7 days.

5. 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, chest discomfort, auscultatory abnormality (wheezing, rhonchi).

6. Clinician consideration or intent to prescribe antibiotics.

Exclusion Criteria:

1. Systemic antibiotics within 72 hours prior to ED/UCC presentation

2. Suspicion and/or confirmed diagnosis of infectious gastroenteritis/colitis

3. Inflammatory disease (e.g., IBD, SLE, RA, Kawasaki, other vasculitis)

4. Congenital immune deficiency (CID)

5. A proven or suspected infection on presentation with Mycobacterial (e.g., MAC, MABC), parasitic or fungal (e.g., Candida, Histoplasma, Aspergillus) pathogen

6. HIV, HBV, or HCV infection (self-declared or known from medical records)

7. Major trauma and\or burns in the last 7 days

8. Major surgery in the last 7 days

9. Pregnancy- self reported or medically confirmed

10. 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.

11. Current treatment with immune-suppressive or immune-modulating therapies, at some point in the past 10 days

12. Consider unsuitable for the study by the study team

Related Conditions & MeSH terms

• Communicable Diseases
• Emergencies
• Infections
• Lower Respiratory Tract Infection
• Respiratory Tract Infections

Intervention

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

Locations

Country	Name	City	State
Israel	Carmel Medical Center	Haifa	North
Israel	Sourasky Medical Center - Ichilov	Tel Aviv
United States	Maimonides Medical Center	Brooklyn	New York
United States	Medical University South Carolina	Charleston	South Carolina
United States	UT Southwestern Medical Center	Dallas	Texas
United States	University of Florida-Jacksonville	Jacksonville	Florida
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	Philadelphia Thomas Jefferson Urgent Care	Philadelphia	Pennsylvania
United States	Stony Brook University Hospital	Stony Brook	New York

Sponsors (1)

Lead Sponsor	Collaborator
MeMed Diagnostics Ltd.

Countries where clinical trial is conducted

United States,  Israel, 

References & Publications (24)

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Bartlett JG. Clinical practice. Antibiotic-associated diarrhea. N Engl J Med. 2002 Jan 31;346(5):334-9. doi: 10.1056/NEJMcp011603. No abstract available. — View Citation

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 — View Citation

Collins 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-Co — View Citation

de la Poza Abad M, Mas Dalmau G, Moreno Bakedano M, Gonzalez Gonzalez AI, Canellas Criado Y, Hernandez Anadon S, Rotaeche del Campo R, Toran Monserrat P, Negrete Palma A, Munoz Ortiz L, Borrell Thio E, Llor C, Little P, Alonso-Coello P; Delayed Antibiotic — View Citation

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. — View Citation

Giannelli FR. Antibiotic-associated diarrhea. JAAPA. 2017 Oct;30(10):46-47. doi: 10.1097/01.JAA.0000524721.01579.c9. No abstract available. — View Citation

Herberg 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 — View Citation

Herberg JA, Kaforou M, Wright VJ, Shailes H, Eleftherohorinou H, Hoggart CJ, Cebey-Lopez M, Carter MJ, Janes VA, Gormley S, Shimizu C, Tremoulet AH, Barendregt AM, Salas A, Kanegaye J, Pollard AJ, Faust SN, Patel S, Kuijpers T, Martinon-Torres F, Burns JC — View Citation

Huang DT, Yealy DM, Filbin MR, Brown AM, Chang CH, Doi Y, Donnino MW, Fine J, Fine MJ, Fischer MA, Holst JM, Hou PC, Kellum JA, Khan F, Kurz MC, Lotfipour S, LoVecchio F, Peck-Palmer OM, Pike F, Prunty H, Sherwin RL, Southerland L, Terndrup T, Weissfeld L — View Citation

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. eCollecti — View Citation

Lim 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. — View Citation

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. — View Citation

Lydon EC, Henao R, Burke TW, Aydin M, Nicholson BP, Glickman SW, Fowler VG, Quackenbush EB, Cairns CB, Kingsmore SF, Jaehne AK, Rivers EP, Langley RJ, Petzold E, Ko ER, McClain MT, Ginsburg GS, Woods CW, Tsalik EL. Validation of a host response test to di — View Citation

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. Cl — View Citation

Oved K, Cohen A, Boico O, Navon R, Friedman T, Etshtein L, Kriger O, Bamberger E, Fonar Y, Yacobov R, Wolchinsky R, Denkberg G, Dotan Y, Hochberg A, Reiter Y, Grupper M, Srugo I, Feigin P, Gorfine M, Chistyakov I, Dagan R, Klein A, Potasman I, Eden E. A n — View Citation

Papan C, Argentiero A, Porwoll M, Hakim U, Farinelli E, Testa I, Pasticci MB, Mezzetti D, Perruccio K, Etshtein L, Mastboim N, Moscoviz E, Ber TI, Cohen A, Simon E, Boico O, Shani L, Gottlieb TM, Navon R, Barash E, Oved K, Eden E, Simon A, Liese JG, Knuf — View Citation

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. — View Citation

Rao 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 Respirat — View Citation

Rowe TA, Linder JA. Novel approaches to decrease inappropriate ambulatory antibiotic use. Expert Rev Anti Infect Ther. 2019 Jul;17(7):511-521. doi: 10.1080/14787210.2019.1635455. Epub 2019 Jul 5. — View Citation

Srugo I, Klein A, Stein M, Golan-Shany O, Kerem N, Chistyakov I, Genizi J, Glazer O, Yaniv L, German A, Miron D, Shachor-Meyouhas Y, Bamberger E, Oved K, Gottlieb TM, Navon R, Paz M, Etshtein L, Boico O, Kronenfeld G, Eden E, Cohen R, Chappuy H, Angoulvan — View Citation

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. — View Citation

van Houten CB, de Groot JAH, Klein A, Srugo I, Chistyakov I, de Waal W, Meijssen CB, Avis W, Wolfs TFW, Shachor-Meyouhas Y, Stein M, Sanders EAM, Bont LJ. A host-protein based assay to differentiate between bacterial and viral infections in preschool chil — View Citation

Wong 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 No — View Citation

* Note: There are 24 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Through study completion, an average of 18 months

External Links

•   A generalizable 29-mRNA neural-network classifier for acute bacterial and viral infections
•   Antimicrobial resistance
•   Measuring Outpatient Antibiotic Prescribin
•   Tackling drug-resistant infections globally: final report and recommendations