Duration of Antibiotic Treatment in Community-acquired Pneumonia (ADAPT)

Instituto de Investigacion Sanitaria La Fe

Status: Enrolling

Conditions: Community-acquired Pneumonia

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05762328

2022-914-1

Details and patient eligibility

About

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.

Enrollment: 2,000 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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2,000 participants in 2 patient groups

Standard of care

No Intervention group

Description:

Patients allocated in hospitals randomized to non-interventional arm. Observational analysis of patients treated by clinicians with standard of care.

Interventional

Other group

Description:

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

Treatment:

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