Clinical trial NCT05762328: Duration of Antibiotic Treatment in Community-acquired Pneumonia
Official title: Adherence to Clinical Guidelines Regarding the Duration of Antibiotic Treatment in Patients Hospitalized for Community-acquired Pneumonia With Clinical sTability. ADAPT Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Community-acquired Pneumonia
Keywords: pneumonia
antibiotic treatment
duration
clinical stability
adherence
Lead sponsor: Instituto de Investigacion Sanitaria La Fe
Sponsor class: OTHER
Collaborators: name: Instituto de Salud Carlos III
name: Sociedad Española de Neumología y Cirugía Torácica
name: Sociedad Valenciana de Neumología
First posted: 2023-03-09
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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)

Primary outcomes:
measure: Duration of antibiotic treatment
timeFrame: 90 days
Secondary outcomes:
measure: Duration of antibiotic treatment after reaching clinical stability
timeFrame: 90 days
measure: Patients treated with an adequate duration of 5±1 days
timeFrame: 90 days
measure: Patients admitted to the ICU after the 5th day
timeFrame: 90 days
measure: Mortality
timeFrame: 90 days
measure: Readmission
timeFrame: 90 days
measure: Reintroduction of antibiotic treatment
timeFrame: 90 days
measure: Length of hospital stay
timeFrame: 90 days
measure: Adverse events related to antibiotic treatment
timeFrame: 90 days
Other outcomes:
measure: Factors related to excess of antibiotic treatment
timeFrame: 90 days
Locations:
city: Valencia
country: Spain
facility: University and Polytechnic Hospital La Fe
Study officials:
affiliation: Instituto de Investigación Sanitaria La Fe
name: Raúl Méndez, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: