Community-acquired PneumoniaADAPTNCT05762328
Duration of Antibiotic Treatment in Community-acquired Pneumonia
A study testing Reminders to the assistant clinicians of the need to adhere to clinical guidelines regarding the duration of antibiotic treatment community-acquired pneumonia in people with Community-acquired Pneumonia, run by Instituto de Investigacion Sanitaria La Fe at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Community-acquired Pneumonia
- What is being tested?
- Reminders to the assistant clinicians of the need to adhere to clinical guidelines regarding the duration of antibiotic treatment community-acquired pneumonia
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2024to Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
University and Polytechnic Hospital La Fe
Valencia
Raúl Méndez, MD, PhD, mendez_rau@gva.es
About this study
Official title: 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.
- Conditions
- Community-acquired Pneumonia
- Being tested
- Reminders to the assistant clinicians of the need to adhere to clinical guidelines regarding the duration of antibiotic treatment community-acquired pneumonia
- Keywords
- pneumonia, antibiotic treatment, duration, clinical stability, adherence
- Medical subject headings
- Community-Acquired Pneumonia, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reminders to the assistant clinicians of the need to adhere to clinical guidelines regarding the duration of antibiotic treatment community-acquired pneumoniaBehavioural
Also called 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
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 group | Role | What they receive |
|---|---|---|
| Standard of care | No intervention | Patients allocated in hospitals randomized to non-interventional arm. Observational analysis of patients treated by clinicians with standard of care. |
| Interventional | Other | 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 Receives: Behavioral: Reminders to the assistant clinicians of the need to adhere to clinical guidelines regarding the duration of antibiotic treatment community-acquired pneumonia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of antibiotic treatment
Total duration in days of antibiotic treatment (including the days of outpatient antibiotic prescribed at discharge).
Measured: 90 days
Secondary outcomes (8)
Duration of antibiotic treatment after reaching clinical stability
Duration in days of antibiotic treatment after reaching clinical stability
Measured: 90 days
Patients treated with an adequate duration of 5±1 days
Percentage of patients treated with an adequate duration of 5±1 days
Measured: 90 days
Patients admitted to the ICU after the 5th day
Percentage of patients admitted to the ICU after the 5th day of admission
Measured: 90 days
Mortality
Percentage of patients who died during the study
Measured: 90 days
Readmission
Percentage of patients who are readmitted after hospital discharge
Measured: 90 days
Reintroduction of antibiotic treatment
Percentage of patients with reintroduction of antibiotic treatment
Measured: 90 days
Length of hospital stay
Length of hospital stay in days
Measured: 90 days
Adverse events related to antibiotic treatment
Percentage of patients with adverse events related to antibiotic treatment
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2023
- Study startJan 2024 (estimated)
- Primary completionJun 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Community-acquired PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigacion Sanitaria La Fe
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Salud Carlos III, Sociedad Española de Neumología y Cirugía Torácica, Sociedad Valenciana de Neumología
- Responsible party
- Principal investigator, Raúl Méndez, MD PhD, Instituto de Investigacion Sanitaria La Fe
- Investigators
- Raúl Méndez, MD, PhD, Principal investigator, Instituto de Investigación Sanitaria La Fe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05762328
- Sponsor's protocol ID
- 2022-914-1
- Acronym
- ADAPT
- Status last verified
- Jan 2024
- First submitted
- 28 Feb 2023
- Last updated
- 11 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adherence to Clinical Guidelines Regarding the Duration of Antibiotic Treatment in Patients Hospitalized for Community-acquired Pneumonia With Clinical sTability. ADAPT Study
- ClinicalTrials.gov ID
- NCT05762328
- Acronym / sponsor ID
- ADAPT / 2022-914-1
- Conditions
- Community-acquired Pneumonia
- Keywords
- pneumonia, antibiotic treatment, duration, clinical stability, adherence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Instituto de Investigacion Sanitaria La FeUniversity, hospital or other
- Collaborators
- Instituto de Salud Carlos III, Sociedad Española de Neumología y Cirugía Torácica, Sociedad Valenciana de Neumología
- Study start
- Jan 2024 (estimated)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 9 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of care | No intervention | –Patients allocated in hospitals randomized to non-interventional arm. Observational analysis of patients treated by clinicians with standard of care. |
| Interventional | Other | Behavioral: Reminders to the assistant clinicians of the need to adhere to clinical guidelines regarding the duration of antibiotic treatment community-acquired pneumoniaPatients 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 |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reminders to the assistant clinicians of the need to adhere to clinical guidelines regarding the duration of antibiotic treatment community-acquired pneumoniaAlso: 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 stabilityAutomatic 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 | Behavioural | Interventional |
Primary outcome
Duration of antibiotic treatment
Time frame: 90 days
Total duration in days of antibiotic treatment (including the days of outpatient antibiotic prescribed at discharge).
8 secondary outcomes
Duration of antibiotic treatment after reaching clinical stability
Time frame: 90 days
Patients treated with an adequate duration of 5±1 days
Time frame: 90 days
Patients admitted to the ICU after the 5th day
Time frame: 90 days
Mortality
Time frame: 90 days
Readmission
Time frame: 90 days
Reintroduction of antibiotic treatment
Time frame: 90 days
Length of hospital stay
Time frame: 90 days
Adverse events related to antibiotic treatment
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2024.
- Individual participant dataSharing planned: Yes
Related trials for Community-acquired Pneumonia
Not yet recruiting
Expanded Diagnostic Strategy in Older Adults Hospitalized With Community-Acquired Acute Respiratory Infection
Acute Respiratory Infection
RecruitingObservational study
Cardiovascular Disease Progression in Survivors of Community Acquired Pneumonia and Lung Infection by Covid-19.
Pneumonia, Community-Acquired, COVID-19 Pneumonia
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
Not yet recruitingPhase 4
Ceftriaxone Dosage for Non-Critical Community-Acquired Pneumonia
Community Acquired Pneumonia (CAP)
Active, not recruitingPhase 2/3
Inhaled Lexofloxacin vs Usual Care for Treatment of Community-Acquired Pneumonia
Community-acquired Pneumonia, CAP
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raúl Méndez, MD, PhD principal investigator
Instituto de Investigación Sanitaria La Fe
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reminders to the assistant clinicians of the need to adhere to clinical guidelines regarding the duration of antibiotic treatment community-acquired pneumonia in people with Community-acquired Pneumonia, run by Instituto de Investigacion Sanitaria La Fe at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Raúl Méndez, MD, PhD (+34 961244000 ext. 485629, rmendezalcoy@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of antibiotic treatment (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2024.