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

Primary Purpose

Community-acquired Pneumonia

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Reminders to the assistant clinicians of the need to adhere to clinical guidelines regarding the duration of antibiotic treatment community-acquired pneumonia
Sponsored by
Instituto de Investigacion Sanitaria La Fe
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Community-acquired Pneumonia focused on measuring pneumonia, antibiotic treatment, duration, clinical stability, adherence

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Other

    Arm Label

    Standard of care

    Interventional

    Arm Description

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

    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

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Duration of antibiotic treatment after reaching clinical stability
    Duration in days of antibiotic treatment after reaching clinical stability
    Patients treated with an adequate duration of 5±1 days
    Percentage of patients treated with an adequate duration of 5±1 days
    Patients admitted to the ICU after the 5th day
    Percentage of patients admitted to the ICU after the 5th day of admission
    Mortality
    Percentage of patients who died during the study
    Readmission
    Percentage of patients who are readmitted after hospital discharge
    Reintroduction of antibiotic treatment
    Percentage of patients with reintroduction of antibiotic treatment
    Length of hospital stay
    Length of hospital stay in days
    Adverse events related to antibiotic treatment
    Percentage of patients with adverse events related to antibiotic treatment

    Full Information

    First Posted
    February 28, 2023
    Last Updated
    February 28, 2023
    Sponsor
    Instituto de Investigacion Sanitaria La Fe
    Collaborators
    Instituto de Salud Carlos III, Sociedad Española de Neumología y Cirugía Torácica, Sociedad Valenciana de Neumología
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05762328
    Brief Title
    Duration of Antibiotic Treatment in Community-acquired Pneumonia
    Acronym
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 2023 (Anticipated)
    Primary Completion Date
    June 2025 (Anticipated)
    Study Completion Date
    August 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Instituto de Investigacion Sanitaria La Fe
    Collaborators
    Instituto de Salud Carlos III, Sociedad Española de Neumología y Cirugía Torácica, Sociedad Valenciana de Neumología

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Community-acquired Pneumonia
    Keywords
    pneumonia, antibiotic treatment, duration, clinical stability, adherence

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    2000 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Standard of care
    Arm Type
    No Intervention
    Arm Description
    Patients allocated in hospitals randomized to non-interventional arm. Observational analysis of patients treated by clinicians with standard of care.
    Arm Title
    Interventional
    Arm Type
    Other
    Arm Description
    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
    Intervention Type
    Behavioral
    Intervention Name(s)
    Reminders to the assistant clinicians of the need to adhere to clinical guidelines regarding the duration of antibiotic treatment community-acquired pneumonia
    Other Intervention Name(s)
    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
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    Duration of antibiotic treatment
    Description
    Total duration in days of antibiotic treatment (including the days of outpatient antibiotic prescribed at discharge).
    Time Frame
    90 days
    Secondary Outcome Measure Information:
    Title
    Duration of antibiotic treatment after reaching clinical stability
    Description
    Duration in days of antibiotic treatment after reaching clinical stability
    Time Frame
    90 days
    Title
    Patients treated with an adequate duration of 5±1 days
    Description
    Percentage of patients treated with an adequate duration of 5±1 days
    Time Frame
    90 days
    Title
    Patients admitted to the ICU after the 5th day
    Description
    Percentage of patients admitted to the ICU after the 5th day of admission
    Time Frame
    90 days
    Title
    Mortality
    Description
    Percentage of patients who died during the study
    Time Frame
    90 days
    Title
    Readmission
    Description
    Percentage of patients who are readmitted after hospital discharge
    Time Frame
    90 days
    Title
    Reintroduction of antibiotic treatment
    Description
    Percentage of patients with reintroduction of antibiotic treatment
    Time Frame
    90 days
    Title
    Length of hospital stay
    Description
    Length of hospital stay in days
    Time Frame
    90 days
    Title
    Adverse events related to antibiotic treatment
    Description
    Percentage of patients with adverse events related to antibiotic treatment
    Time Frame
    90 days
    Other Pre-specified Outcome Measures:
    Title
    Factors related to excess of antibiotic treatment
    Description
    Factors o variables related to excess of antibiotic treatment
    Time Frame
    90 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    100 Years
    Accepts Healthy Volunteers
    No
    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)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Raúl Méndez, MD, PhD
    Phone
    +34 961244000
    Ext
    485629
    Email
    rmendezalcoy@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Raúl Méndez, MD, PhD
    Organizational Affiliation
    Instituto de Investigación Sanitaria La Fe
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes

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