Duration of Antibiotic Treatment in Community-acquired Pneumonia
- Conditions
- Community-acquired Pneumonia
- Interventions
- Behavioral: Reminders to the assistant clinicians of the need to adhere to clinical guidelines regarding the duration of antibiotic treatment community-acquired pneumonia
- Registration Number
- NCT05762328
- Lead Sponsor
- Instituto de Investigacion Sanitaria La Fe
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 2000
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Interventional Reminders to the assistant clinicians of the need to adhere to clinical guidelines regarding the duration of antibiotic treatment community-acquired pneumonia 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
- Primary Outcome Measures
Name Time Method Duration of antibiotic treatment 90 days Total duration in days of antibiotic treatment (including the days of outpatient antibiotic prescribed at discharge).
- Secondary Outcome Measures
Name Time Method Mortality 90 days Percentage of patients who died during the study
Length of hospital stay 90 days Length of hospital stay in days
Duration of antibiotic treatment after reaching clinical stability 90 days Duration in days of antibiotic treatment after reaching clinical stability
Adverse events related to antibiotic treatment 90 days Percentage of patients with adverse events related to antibiotic treatment
Readmission 90 days Percentage of patients who are readmitted after hospital discharge
Reintroduction of antibiotic treatment 90 days Percentage of patients with reintroduction of antibiotic treatment
Patients treated with an adequate duration of 5±1 days 90 days Percentage of patients treated with an adequate duration of 5±1 days
Patients admitted to the ICU after the 5th day 90 days Percentage of patients admitted to the ICU after the 5th day of admission
Trial Locations
- Locations (1)
University and Polytechnic Hospital La Fe
🇪🇸Valencia, Spain