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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Community-acquired Pneumonia
• Intervention / Treatment: 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
• Enrollment (Estimated): 2000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Raúl Méndez, MD, PhD; Phone Number: 485629 +34 961244000; Email: rmendezalcoy@gmail.com

Study Locations

• Spain
  • Valencia, Spain
    • Recruiting
    • University and Polytechnic Hospital La fe
    • Contact: Raúl Méndez, MD, PhD; Email: mendez_rau@gva.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard of care; Patients allocated in hospitals randomized to non-interventional arm. Observational analysis of patients treated by clinicians with standard of care.
Other: 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	Behavioral: 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; 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?

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
Length of hospital stay	Length of hospital stay in days	90 days
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
Adverse events related to antibiotic treatment	Percentage of patients with adverse events related to antibiotic treatment	90 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Factors related to excess of antibiotic treatment	Factors o variables related to excess of antibiotic treatment	90 days

Collaborators and Investigators

• Sponsor: Instituto de Investigacion Sanitaria La Fe
• Collaborators: Sociedad Española de Neumología y Cirugía Torácica; Sociedad Valenciana de Neumología; Instituto de Salud Carlos III
• Investigators: Principal Investigator: Raúl Méndez, MD, PhD, Instituto de Investigación Sanitaria La Fe

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2024
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: February 28, 2023
• First Submitted That Met QC Criteria: February 28, 2023
• First Posted (Actual): March 9, 2023

Study Record Updates

• Last Update Posted (Actual): January 11, 2024
• Last Update Submitted That Met QC Criteria: January 9, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: adherence; pneumonia; antibiotic treatment; duration; clinical stability
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Pneumonia; Anti-Infective Agents; Antitubercular Agents; Anti-Bacterial Agents; Antibiotics, Antitubercular
• Other Study ID Numbers: 2022-914-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No