Targeted Antibiotic Therapy for Pneumonia
Recruiting in Palo Alto (17 mi)
+11 other locations
Overseen ByMichael Rothberg, M.D.
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: The Cleveland Clinic
No Placebo Group
Trial Summary
What is the purpose of this trial?The purpose of this study is to reduce the exposure of broad-spectrum antimicrobials by optimizing the rapid detection of CAP pathogens and improving rates of de-escalation following negative cultures. To accomplish this, we will perform a 3-year, pragmatic, multicenter 2 X 2 factorial cluster randomized controlled trial with four arms: a) rapid diagnostic testing b) pharmacist-led de-escalation c) rapid diagnostic testing + pharmacist-led de-escalation and d) usual care
How does targeted antibiotic therapy for pneumonia differ from other treatments?
Targeted antibiotic therapy for pneumonia is unique because it focuses on using specific antibiotics that are effective against multidrug-resistant bacteria, like Pseudomonas aeruginosa, which are difficult to treat with standard antibiotics. This approach may involve newer antibiotics such as ceftolozane-tazobactam and ceftazidime-avibactam, which are designed to combat resistant strains more effectively.
12389What data supports the effectiveness of the drug Meropenem-Vaborbactam for treating pneumonia?
Meropenem-Vaborbactam has shown effectiveness in treating infections caused by carbapenem-resistant Enterobacteriaceae (CRE), particularly those involving Klebsiella pneumoniae, which is a common cause of pneumonia. It has been demonstrated to be effective in treating complicated urinary tract infections and other invasive infections, suggesting its potential usefulness in treating pneumonia caused by similar resistant bacteria.
456710Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Eligibility Criteria
This trial is for adults over 18 with pneumonia, admitted to a participating hospital without intensive care in the first 24 hours, not on comfort care only, without cystic fibrosis or recent discharge from acute care. It excludes those known to have a specific pathogen causing their illness.Inclusion Criteria
I have been diagnosed with pneumonia.
Exclusion Criteria
I was admitted to the ICU within 24 hours of being hospitalized.
I am only receiving treatments to ease symptoms.
I have cystic fibrosis.
Participant Groups
The study tests if rapid diagnostic testing and pharmacist-led de-escalation can reduce broad-spectrum antimicrobial use in community-acquired pneumonia. It's a 3-year trial with four groups: one gets rapid tests, another gets pharmacist help, one gets both, and the last follows usual care.
4Treatment groups
Active Control
Group I: Rapid diagnostic testing (RDT)Active Control1 Intervention
Rapid diagnostic testing: Eligible patients at hospitals randomized to this arm will undergo testing for viral pathogens (from November-April) and pneumococcal UAT testing. If the patient is not being admitted to the ICU, and the patient has an admitting diagnosis of pneumonia, the form will append orders for viral testing and UAT testing to providers in hospitals randomized to receive it.
Group II: Pharmacist-led de-escalationActive Control1 Intervention
Pharmacist-led de-escalation: Another CDSS algorithm will identify CAP patients who meet study criteria and have negative culture results for \> 48 hours and generate a list for the clinical pharmacist, who will be a member of the study team. The alerts will be audited by the pharmacist daily on weekdays at a centralized location. The pharmacist will attempt to determine whether each patient is clinically stable. The validated measures of clinical stability in patients with CAP are a) resolved vital sign abnormalities b) normal mental status c) ability to eat. If the patient appears stable, the pharmacist will communicate their recommendations for de-escalation to the clinical providers via a phone call or page.
Group III: Rapid diagnostic testing (RDT) and Pharmacist-led de-escalationActive Control2 Interventions
Rapid diagnostic testing: Eligible patients at hospitals randomized to this arm will undergo testing for viral pathogens (from November-April) and pneumococcal UAT testing. If the patient is not being admitted to the ICU, and the patient has an admitting diagnosis of pneumonia, the form will append orders for viral testing and UAT testing to providers in hospitals randomized to receive it.
Pharmacist-led de-escalation: Another CDSS algorithm will identify CAP patients who meet study criteria and have negative culture results for \>48-hours and generate a list for the clinical pharmacist, who will be a member of the study team. The alerts will be audited by the pharmacist daily on weekdays at a centralized location. The pharmacist will attempt to determine whether each patient is clinically stable. If the patient appears stable, the pharmacist will communicate their recommendations for de-escalation to the clinical providers via a phone call or page.
Group IV: Usual care (no intervention)Active Control1 Intervention
Usual care
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Euclid HospitalEuclid, OH
Fairview HospitalFairview Park, OH
South Pointe HospitalWarrensville Heights, OH
Akron General HospitalAkron, OH
More Trial Locations
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Who is running the clinical trial?
The Cleveland ClinicLead Sponsor
References
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Meropenem-vaborbactam: a new weapon in the war against infections due to resistant Gram-negative bacteria. [2019]Meropenem-vaborbactam is a fixed-dose combination product of a carbapenem and a cyclic boronic acid β-lactamase inhibitor with potent in vitro activity against Klebsiella pneumoniae carbapenemase-producing carbapenem-resistant Enterobacteriaceae (CRE). The efficacy of meropenem-vaborbactam for the treatment of complicated urinary tract infections and acute pyelonephritis was demonstrated in a Phase III trial (TANGO I). Preliminary data from TANGO II, a separate Phase III study, support the efficacy of meropenem-vaborbactam for the treatment of infections caused by CRE. Overall, meropenem-vaborbactam appears to be safe and well tolerated. It has favorable toxicity, pharmacokinetic and pharmacodynamic profiles compared with other antibiotics with activity against CRE. Meropenem-vaborbactam is an important addition to the current armamentarium of antimicrobial agents with activity against K. pneumoniae carbapenemase-producing CRE.
Meropenem-vaborbactam for adults with complicated urinary tract and other invasive infections. [2019]Complicated urinary tract infections are increasingly caused by multidrug-resistant organisms. Carbapenem-resistant Enterobacteriaceae (CRE) constitute a rising threat among uropathogens with significant morbidity and mortality. Meropenem-vaborbactam is a novel carbapenem and cyclic boronic acid-based beta-lactamase inhibitor combination with potent activity against subtypes of CRE. Areas covered: This article reviews mechanisms of carbapenem resistance, existing treatment options for CRE, and the current evidence to support the use of meropenem-vaborbactam for the treatment of infections caused by subtypes of CRE including complicated urinary tract infections. Expert commentary: Meropenem-vaborbactam is a superior treatment option for infections secondary to Klebsiella pneumoniae carbapenemase (KPC)-producing CRE. It is associated with higher rates of treatment success and lower rates of toxicity than traditional agents and demonstrates a potentially higher barrier to acquired antimicrobial resistance than ceftazidime-avibactam. At present, meropenem-vaborbactam should be regarded as a preferred treatment option for invasive infections secondary to KPC-producing CRE.
Meropenem-Vaborbactam (Vabomere™): Another Option for Carbapenem-Resistant Enterobacteriaceae. [2020]Meropenem-Vaborbactam (Vabomere) for carbapenem-resistant Enterobacteriaceae.
Efficacy and Safety of Meropenem-Vaborbactam Versus Best Available Therapy for the Treatment of Carbapenem-Resistant Enterobacteriaceae Infections in Patients Without Prior Antimicrobial Failure: A Post Hoc Analysis. [2020]Infections due to Klebsiella pneumoniae carbapenemase (KPC)-producing Enterobacteriaceae are associated with increased morbidity and high mortality. Meropenem-vaborbactam (MV) is a novel β-lactam/β-lactamase inhibitor combination active against KPC-producing Enterobacteriaceae. The aim of this post hoc analysis of the TANGO-II randomized controlled trial was to assess the efficacy of MV versus best available therapy (BAT) in the subgroup of patients without prior antimicrobial failure.
Approach to the Treatment of Patients with Serious Multidrug-Resistant Pseudomonas aeruginosa Infections. [2021]Multidrug resistance(MDR) among Pseudomonas aeruginosa (PSA) isolates presents a significant clinical challenge and can substantially complicate the approach to selection of optimal antibiotic therapy. This review addresses major considerations in antibiotic selection for patients with suspected or documented serious MDR-PSA infections. Common mechanisms contributing to MDR among clinical PSA isolates are summarized. Empiric and definitive therapy considerations are addressed including the potential role of combination therapy. Newer agents with in vitro activity against MDR-PSA (e.g., ceftolozane-tazobactam, ceftazidime-avibactam, imipenem-relebactam, and cefiderocol) and their potential roles in clinical settings are discussed. Although these newer agents are promising options for the treatment of MDR-PSA, clinical data remain generally limited. Future studies are needed to determine optimal agents for the empiric and definitive treatment of MDR-PSA.
Trimethoprim-sulfamethoxazole as de-escalation in ventilator-associated pneumonia: a cohort study subanalysis. [2021]This is a subanalysis of a previous study which compared the effectiveness of trimetoprim-sulfametoxazole (TMP-SMX) with all other regimens for treatment of ventilator-associated pneumonia (VAP). Aim of the current study was to focus on the effectiveness of a strategy based on TMP-SMX as de-escalation from β-lactam including regimens.
Cost-effectiveness analysis of Vaborem in Carbapenem-resistant Enterobacterales (CRE) -Klebsiella pneumoniae infections in Italy. [2021]Vaborem is a fixed dose combination of vaborbactam and meropenem with potent activity against target Carbapenem-resistant Enterobacterales (CRE) pathogens, optimally developed for Klebsiella pneumoniae carbapenemase (KPC). The study aims to evaluate the cost-effectiveness of Vaborem versus best available therapy (BAT) for the treatment of patients with CRE-KPC associated infections in the Italian setting.