Duration of Antibiotic Treatment in Community-acquired Pneumonia

NCT ID: NCT05762328

Last Updated: 2024-01-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 2000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-31
• Study Completion Date: 2025-08-31

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.

Conditions

Community-acquired Pneumonia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Standard of care

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventional

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

Group Type: OTHER

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

Intervention Type: BEHAVIORAL

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

Interventions

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

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

Intervention Type: BEHAVIORAL

Other Intervention 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

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto de Salud Carlos III

OTHER_GOV

Sponsor Role: collaborator

Sociedad Española de Neumología y Cirugía Torácica

OTHER

Sponsor Role: collaborator

Sociedad Valenciana de Neumología

UNKNOWN

Sponsor Role: collaborator

Instituto de Investigacion Sanitaria La Fe

OTHER

Sponsor Role: lead

Responsible Party

Raúl Méndez, MD PhD

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Raúl Méndez, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Instituto de Investigación Sanitaria La Fe

Locations

University and Polytechnic Hospital La Fe

Valencia, , Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Raúl Méndez, MD, PhD

Role: CONTACT

rmendezalcoy@gmail.com

+34 961244000 ext. 485629

Facility Contacts

Raúl Méndez, MD, PhD

Role: primary

mendez_rau@gva.es

Other Identifiers

2022-914-1

Identifier Type: -

Identifier Source: org_study_id