Study Summary
This trial will test if reducing exposure to broad-spectrum antibiotics can help detect & reduce infections faster.
Eligible Conditions
- Community-acquired Pneumonia
- Antimicrobial Stewardship
- Point of Care Testing
Treatment Effectiveness
Phase-Based Effectiveness
N/A
Study Objectives
1 Primary · 21 Secondary · Reporting Duration: days from the time of admission to the time of discharge
Up to 48 hours
detection of influenza virus (yes/no)
viral testing ordered (yes/no)
Hour 72
Cross Infection
Day 21
Antibiotics
days from the time of admission to the time of discharge
hospital length-of-stay (days, hours)
Day 21
Number of days of broad-spectrum antibiotic therapy
Day 21
Empyema
Day 21
total inpatient cost (from hospital's cost accounting system)
up to 14 days
14-day mortality
up to 21 days
ICU transfer after admission (> 24 hours after admission)
Kidney Failure, Acute
total duration of any antibacterial antibiotic
up to 30 days
30-day mortality
Day 30
30-day readmission (yes/no)
up to 48 hours
S. pneumoniae urinary antigen test (UAT) performed
detection of RSV (yes/no)
Atypical Bacterial Forms
Pneumococcal vaccine
Pharmaceutical Preparations
Month 6
Communicable Diseases
within 21 days
Antiviral Agents
Hour 72
de-escalation by 72 hours from admission (yes/no)
Trial Safety
Phase-Based Safety
Awards & Highlights
No Placebo Group
All patients enrolled in this trial will receive the new treatment.
Trial Design
4 Treatment Groups
Pharmacist-led de-escalation
1 of 4
Rapid diagnostic testing (RDT)
1 of 4
Rapid diagnostic testing (RDT) and Pharmacist-led de-escalation
1 of 4
Usual care (no intervention)
1 of 4
Active Control
12500 Total Participants · 4 Treatment Groups
Primary Treatment: Pharmacist-led de-escalation · No Placebo Group · N/A
Pharmacist-led de-escalation
Other
ActiveComparator Group · 1 Intervention: Pharmacist-led de-escalation · Intervention Types: OtherRapid diagnostic testing (RDT)
DiagnosticTest
ActiveComparator Group · 1 Intervention: Rapid Diagnostic Testing · Intervention Types: DiagnosticTestRapid diagnostic testing (RDT) and Pharmacist-led de-escalationActiveComparator Group · 2 Interventions: Pharmacist-led de-escalation, Rapid Diagnostic Testing · Intervention Types: Other, DiagnosticTest
Usual care (no intervention)NoIntervention Group · 1 Intervention: Usual care (no intervention) · Intervention Types:
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: days from the time of admission to the time of discharge
Who is running the clinical trial?
The Cleveland ClinicLead Sponsor
968 Previous Clinical Trials
1,348,756 Total Patients Enrolled
Michael Rothberg, M.D.Principal InvestigatorThe Cleveland Clinic
1 Previous Clinical Trials
3,000 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 0 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:References
- Schimmel JJ, Haessler S, Imrey P, Lindenauer PK, Richter SS, Yu PC, Rothberg MB. Pneumococcal Urinary Antigen Testing in United States Hospitals: A Missed Opportunity for Antimicrobial Stewardship. Clin Infect Dis. 2020 Sep 12;71(6):1427-1434. doi: 10.1093/cid/ciz983.
- Klompas M, Imrey PB, Yu PC, Rhee C, Deshpande A, Haessler S, Zilberberg MD, Rothberg MB. Respiratory viral testing and antibacterial treatment in patients hospitalized with community-acquired pneumonia. Infect Control Hosp Epidemiol. 2021 Jul;42(7):817-825. doi: 10.1017/ice.2020.1312. Epub 2020 Dec 1.
- Allgaier J, Lagu T, Haessler S, Imrey PB, Deshpande A, Guo N, Rothberg MB. Risk Factors, Management, and Outcomes of Legionella Pneumonia in a Large, Nationally Representative Sample. Chest. 2021 May;159(5):1782-1792. doi: 10.1016/j.chest.2020.12.013. Epub 2020 Dec 19.
- Metlay, Joshua P., Grant W. Waterer, Ann C. Long, Antonio Anzueto, Jan Brozek, Kristina Crothers, Laura A. Cooley, et al.. 2019. “Diagnosis and Treatment of Adults with Community-acquired Pneumonia. An Official Clinical Practice Guideline of the American Thoracic Society and Infectious Diseases Society of America”. American Journal of Respiratory and Critical Care Medicine. American Thoracic Society. doi:10.1164/rccm.201908-1581st.
- Deshpande A, Richter SS, Haessler S, Lindenauer PK, Yu PC, Zilberberg MD, Imrey PB, Higgins T, Rothberg MB. De-escalation of Empiric Antibiotics Following Negative Cultures in Hospitalized Patients With Pneumonia: Rates and Outcomes. Clin Infect Dis. 2021 Apr 26;72(8):1314-1322. doi: 10.1093/cid/ciaa212.
- Madaras-Kelly K, Jones M, Remington R, Caplinger CM, Huttner B, Jones B, Samore M. Antimicrobial de-escalation of treatment for healthcare-associated pneumonia within the Veterans Healthcare Administration. J Antimicrob Chemother. 2016 Feb;71(2):539-46. doi: 10.1093/jac/dkv338. Epub 2015 Nov 3.
- Musher DM, Thorner AR. Community-acquired pneumonia. N Engl J Med. 2014 Oct 23;371(17):1619-28. doi: 10.1056/NEJMra1312885. Review.
- Belforti RK, Lagu T, Haessler S, Lindenauer PK, Pekow PS, Priya A, Zilberberg MD, Skiest D, Higgins TL, Stefan MS, Rothberg MB. Association Between Initial Route of Fluoroquinolone Administration and Outcomes in Patients Hospitalized for Community-acquired Pneumonia. Clin Infect Dis. 2016 Jul 1;63(1):1-9. doi: 10.1093/cid/ciw209. Epub 2016 Apr 5.
- Jain S, Self WH, Wunderink RG, Fakhran S, Balk R, Bramley AM, Reed C, Grijalva CG, Anderson EJ, Courtney DM, Chappell JD, Qi C, Hart EM, Carroll F, Trabue C, Donnelly HK, Williams DJ, Zhu Y, Arnold SR, Ampofo K, Waterer GW, Levine M, Lindstrom S, Winchell JM, Katz JM, Erdman D, Schneider E, Hicks LA, McCullers JA, Pavia AT, Edwards KM, Finelli L; CDC EPIC Study Team. Community-Acquired Pneumonia Requiring Hospitalization among U.S. Adults. N Engl J Med. 2015 Jul 30;373(5):415-27. doi: 10.1056/NEJMoa1500245. Epub 2015 Jul 14.
- Higgins TL, Deshpande A, Zilberberg MD, Lindenauer PK, Imrey PB, Yu PC, Haessler SD, Richter SS, Rothberg MB. Assessment of the Accuracy of Using ICD-9 Diagnosis Codes to Identify Pneumonia Etiology in Patients Hospitalized With Pneumonia. JAMA Netw Open. 2020 Jul 1;3(7):e207750. doi: 10.1001/jamanetworkopen.2020.7750.
- Haessler S, Lindenauer PK, Zilberberg MD, Imrey PB, Yu PC, Higgins T, Deshpande A, Rothberg MB. Blood Cultures Versus Respiratory Cultures: 2 Different Views of Pneumonia. Clin Infect Dis. 2020 Oct 23;71(7):1604-1612. doi: 10.1093/cid/ciz1049.
- Musher DM, Thorner AR. Community-acquired pneumonia. N Engl J Med. 2014 Oct 23;371(17):1619-28. doi: 10.1056/NEJMra1312885. No abstract available.
- Michael Rothberg 2022. "Reducing Antimicrobial Overuse Through Targeted Therapy for Patients With Community-Acquired Pneumonia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05568654.
Frequently Asked Questions
How many participants have contributed to this research endeavor?
"Affirmative. The clinicaltrials.gov website reveals that the trial, which first went live on November 1st 2022, is still in search of participants. A total of 12500 patients must be recruited from 4 distinct sites to complete the study." - Anonymous Online Contributor
Unverified Answer
Are there any Canadian medical facilities conducting this research project?
"As of right now, the 4 sites running this medical trial are located in Avon, Fairview Park, Garfield Heights and multiple other areas. To facilitate participation, it is advisable to pick the closest clinic available so that any travel demands can be minimized." - Anonymous Online Contributor
Unverified Answer
Does this research offer any vacancies for participants?
"Affirmative. As per the information available on clinicaltrials.gov, this medical trial remains open and is currently seeking participants. It was announced on November 1st 2022 with a subsequent update made 13 days later; 12500 individuals are required to be recruited from 4 different medical centres." - Anonymous Online Contributor
Unverified Answer