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Targeted Antibiotic Therapy for Pneumonia

N/A

Recruiting

Led By Michael Rothberg, M.D.

Research Sponsored by The Cleveland Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Admitting diagnosis of pneumonia

Be older than 18 years old

Must not have

Admission to intensive care unit within 24 hours of hospital admission

Comfort care measures only

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from 48 hours to 21 days

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if reducing exposure to broad-spectrum antibiotics can help detect & reduce infections faster.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While this trial focuses on treatment processes rather than drugs themselves, potential side effects may include discomfort from diagnostic procedures or changes in medication management by pharmacists.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with pneumonia.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I was admitted to the ICU within 24 hours of being hospitalized.

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I am only receiving treatments to ease symptoms.

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I have cystic fibrosis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ days from the time of admission to the time of discharge

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~days from the time of admission to the time of discharge

This trial's timeline: 3 weeks for screening, Varies for treatment, and days from the time of admission to the time of discharge for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of days of broad-spectrum antibiotic therapy

Secondary study objectives

14-day mortality

30-day mortality

30-day readmission (yes/no)

+18 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Active Control

Group I: Rapid diagnostic testing (RDT)Active Control1 Intervention

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

0 / 4Eligibility criteria met