Duration of Antibiotic Treatment in Community-acquired Pneumonia

Community-acquired Pneumonia Clinical Trial

— ADAPT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05762328
• Other study ID #: 2022-914-1
• Status: Recruiting
• Phase: N/A
• Start date: January 2024
• Est. completion date: August 2025

Study information

• Verified date: January 2024
• Source: Instituto de Investigacion Sanitaria La Fe
• Contact: Raúl Méndez, MD, PhD
• Phone: +34 961244000
• Email: rmendezalcoy[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: August 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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)

Related Conditions & MeSH terms

• Community-acquired Pneumonia
• Pneumonia

Intervention

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

Locations

Country	Name	City	State
Spain	University and Polytechnic Hospital La Fe	Valencia

Sponsors (4)

Lead Sponsor	Collaborator
Instituto de Investigacion Sanitaria La Fe	Instituto de Salud Carlos III, Sociedad Española de Neumología y Cirugía Torácica, Sociedad Valenciana de Neumología

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Factors related to excess of antibiotic treatment	Factors o variables related to excess of antibiotic treatment	90 days
Primary	Duration of antibiotic treatment	Total duration in days of antibiotic treatment (including the days of outpatient antibiotic prescribed at discharge).	90 days
Secondary	Duration of antibiotic treatment after reaching clinical stability	Duration in days of antibiotic treatment after reaching clinical stability	90 days
Secondary	Patients treated with an adequate duration of 5±1 days	Percentage of patients treated with an adequate duration of 5±1 days	90 days
Secondary	Patients admitted to the ICU after the 5th day	Percentage of patients admitted to the ICU after the 5th day of admission	90 days
Secondary	Mortality	Percentage of patients who died during the study	90 days
Secondary	Readmission	Percentage of patients who are readmitted after hospital discharge	90 days
Secondary	Reintroduction of antibiotic treatment	Percentage of patients with reintroduction of antibiotic treatment	90 days
Secondary	Length of hospital stay	Length of hospital stay in days	90 days
Secondary	Adverse events related to antibiotic treatment	Percentage of patients with adverse events related to antibiotic treatment	90 days