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Duration of Antibiotic Treatment in Community-acquired Pneumonia

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05762328
Acronym
ADAPT
Enrollment
2000
Registered
2023-03-09
Start date
2024-01-31
Completion date
2025-08-31
Last updated
2024-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Community-acquired Pneumonia

Keywords

pneumonia, antibiotic treatment, duration, clinical stability, adherence

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.

Interventions

BEHAVIORALReminders 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

Sponsors

Instituto de Salud Carlos III
CollaboratorOTHER_GOV
Sociedad Española de Neumología y Cirugía Torácica
CollaboratorOTHER
Sociedad Valenciana de Neumología
CollaboratorUNKNOWN
Instituto de Investigacion Sanitaria La Fe
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Duration of antibiotic treatment90 daysTotal duration in days of antibiotic treatment (including the days of outpatient antibiotic prescribed at discharge).

Secondary

MeasureTime frameDescription
Length of hospital stay90 daysLength of hospital stay in days
Adverse events related to antibiotic treatment90 daysPercentage of patients with adverse events related to antibiotic treatment
Patients admitted to the ICU after the 5th day90 daysPercentage of patients admitted to the ICU after the 5th day of admission
Mortality90 daysPercentage of patients who died during the study
Reintroduction of antibiotic treatment90 daysPercentage of patients with reintroduction of antibiotic treatment
Duration of antibiotic treatment after reaching clinical stability90 daysDuration in days of antibiotic treatment after reaching clinical stability
Patients treated with an adequate duration of 5±1 days90 daysPercentage of patients treated with an adequate duration of 5±1 days
Readmission90 daysPercentage of patients who are readmitted after hospital discharge

Other

MeasureTime frameDescription
Factors related to excess of antibiotic treatment90 daysFactors o variables related to excess of antibiotic treatment

Countries

Spain

Contacts

Primary ContactRaúl Méndez, MD, PhD
rmendezalcoy@gmail.com+34 961244000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026