Duration of Antibiotic Treatment in Community-acquired Pneumonia

Study Overview
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Brief Summary
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International and national clinical guidelines recommend short antibiotic regimens in patients with non-severe community-acquired pneumonia (CAP) who have reached clinical stability. However, adherence to these recommendations remains unclear. The goals of this quasi-experimental trial are: 1) to assess adherence to clinical guidelines in relation to the duration of antibiotic treatment in patients hospitalized for non-severe CAP who have reached clinical stability; 2) increase adherence to clinical guidelines and reduce the use of antibiotics in patients hospitalized for non-severe CAP who have achieved clinical stability after at least 5 days of antibiotic treatment. To this end, a multicenter prospective study will be carried out over 2 years and divided into 2 phases: i) during the first year (observational phase), patients with CAP hospitalized in the participating centers will be recorded to assess objective 1; ii) to achieve objective 2, at the beginning of the second year (quasi-experimental trial) the centers will be randomized into 2 groups of hospitals, one of them a control group and the other an intervention group. The intervention will consist in automatic reminders through pop-up windows in the computerized prescription software, reminding the clinician responsible for each patient of the need to adhere to clinical guidelines regarding the duration of antibiotic treatment in patients with clinical stability.

Official Title
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Adherence to Clinical Guidelines Regarding the Duration of Antibiotic Treatment in Patients Hospitalized for Community-acquired Pneumonia With Clinical sTability. ADAPT Study

Conditions
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Community-acquired Pneumonia

Intervention / Treatment
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* Behavioral: Reminders to the assistant clinicians of the need to adhere to clinical guidelines regarding the duration of antibiotic treatment community-acquired pneumonia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients >18 years hospitalized for community-acquired pneumonia with a new infiltrate on chest X-ray and/or computerized tomography. At least one compatible sign or symptom (fever, cough, expectoration, dyspnea, chest pain or crackles on auscultation) Correctly treated with ≥ 3 days of antibiotic Exclusion Criteria: Intensive care unit admission during the first 5 days since hospital admission Abscess or necrotizing pneumonia Empyema or pleural effusion requiring drainage tube Bronchiectasis Cystic fibrosis Active tuberculosis Postobstructive pneumonia Suspected bronchial aspiration SARS-CoV-2 infection Immunosuppression (congenital immunodeficiencies, HIV infection, solid organ transplantation, functional or anatomical asplenia, immunosuppressive treatment, active solid or haematological neoplasia [active treatment in the last 12 months], etc.) Hospital acquired pneumonia Concomitant extrapulmonary infection that requires antibiotic treatment for more than 5 days (eg myocarditis) Confirmed diagnosis alternative to pneumonia (eg, lung cancer)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard of care<br>Patients allocated in hospitals randomized to non-interventional arm. Observational analysis of patients treated by clinicians with standard of care. | |
| Other: Interventional<br>Patients allocated in hospitals randomized to interventional arm. Intervention: automatic reminders through pop-up windows in the computerized prescription software, reminding the clinician responsible for each patient of the need to adhere to clinical guidelines regarding the duration of antibiotic treatment in patients with clinical stability | Behavioral: Reminders to the assistant clinicians of the need to adhere to clinical guidelines regarding the duration of antibiotic treatment community-acquired pneumonia<br>* Automatic reminders through pop-up windows in the computerized prescription software, reminding the clinician responsible for each patient of the need to adhere to clinical guidelines regarding the duration of antibiotic treatment in patients with clinical stability<br>* Other names: Reminders to the clinician responsible for each patient of the need to adhere to clinical guidelines regarding the duration of antibiotic treatment in patients with clinical stability;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of antibiotic treatment | Total duration in days of antibiotic treatment (including the days of outpatient antibiotic prescribed at discharge). | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of antibiotic treatment after reaching clinical stability | Duration in days of antibiotic treatment after reaching clinical stability | 90 days | 
| Patients treated with an adequate duration of 5±1 days | Percentage of patients treated with an adequate duration of 5±1 days | 90 days | 
| Patients admitted to the ICU after the 5th day | Percentage of patients admitted to the ICU after the 5th day of admission | 90 days | 
| Mortality | Percentage of patients who died during the study | 90 days | 
| Readmission | Percentage of patients who are readmitted after hospital discharge | 90 days | 
| Reintroduction of antibiotic treatment | Percentage of patients with reintroduction of antibiotic treatment | 90 days | 
| Length of hospital stay | Length of hospital stay in days | 90 days | 
| Adverse events related to antibiotic treatment | Percentage of patients with adverse events related to antibiotic treatment | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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duration, pneumonia, antibiotic treatment, clinical stability, adherence