Duration of Antibiotic Treatment in Community-acquired Pneumonia

NCT05762328 | Unknown

• 1 other identifier: 2022-914-1
• Study Type: interventional
• Target: 2,000
• Locations: 1 country
• Sites: 1

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

Keywords

pneumonia; antibiotic treatment; duration; clinical stability; adherence

Outcome Measures

Primary Outcomes (1)

• Duration of antibiotic treatment

  Total duration in days of antibiotic treatment (including the days of outpatient antibiotic prescribed at discharge).

  90 days

Secondary Outcomes (8)

• Duration of antibiotic treatment after reaching clinical stability

  90 days

• Patients treated with an adequate duration of 5±1 days

  90 days

• Patients admitted to the ICU after the 5th day

  90 days

• Mortality

  90 days

• Readmission

  90 days

Other Outcomes (1)

• Factors related to excess of antibiotic treatment

  90 days

Study Arms (2)

Standard of care

NO INTERVENTION

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

Interventional

OTHER

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

Interventions

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

Also known as: 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

Interventional

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Instituto de Investigacion Sanitaria La Fe: lead
• Instituto de Salud Carlos III: collaborator
• Sociedad Española de Neumología y Cirugía Torácica: collaborator
• Sociedad Valenciana de Neumología: collaborator

Study Sites (1)

University and Polytechnic Hospital La Fe

Valencia, Spain

RECRUITING

MeSH Terms

Conditions

Community-Acquired Pneumonia; Pneumonia

Condition Hierarchy (Ancestors)

Community-Acquired Infections; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases

Study Officials

• Raúl Méndez, MD, PhD

  Instituto de Investigación Sanitaria La Fe

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Raúl Méndez, MD, PhD

CONTACT

+34 961244000; rmendezalcoy@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: February 28, 2023
• First Posted: March 9, 2023
• Study Start: January 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: August 1, 2025
• Last Updated: January 11, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR

Locations

ES (1)