PneumoniaHCAPPED-INCT06506617
HCAPPED I: HCAP-Pcr in Emergency Department
An observational study of Pneumonia and Bronchoalveolar Lavage, run by Azienda Ospedaliero-Universitaria Careggi at 1 site in Italy.
Trial summary
Prospective Observational Study (on Diagnostic Procedure) - Single-Center, Non-Profit. A pilot study will be conducted on a prospective cohort of patients with HCAP (Healthcare-Associated Pneumonia). This study will be conducted on a single arm of patients. No control group or randomization is planned. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia, Bronchoalveolar Lavage, Antimicrobial Treatment
- How many people
- 93 participants
- Where
- 1 siteItaly
- Study dates
- 7 Jun 2024to 7 Jan 2026
- How long will I take part?
- 90 Days
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients over the age of 18 who undergo bronchoalveolar lavage (BAL) in the Emergency Department (DEA), with a Rankin score of less than 5, and who are admitted to the Emergency Department with a diagnosis of healthcare-associated pneumonia (HCAP) of bacterial, viral, or fungal origin. A patient is considered to have HCAP if they meet any of the following conditions: Hospitalized in an acute care hospital for two or more days within 90 days of symptom onset Residing in a nursing home or long-term care facility Received intravenous antibiotic therapy, chemotherapy, or wound care within the past 30 days Attended a hospital or hemodialysis clinic within the past 30 days for medical reasons, visits, or day services
Who may be able to join
- All patients over the age of 18 who undergo bronchoalveolar lavage (BAL) in the Emergency Department (DEA), with a Rankin score of less than 5, and who are admitted to the Emergency Department with a diagnosis of healthcare-associated pneumonia (HCAP) of bacterial, viral, or fungal origin. The diagnosis must be confirmed by clinical and radiological criteria according to the IDSA guidelines, which include: New pulmonary infiltrate on chest X-ray, Evidence that the infiltrate is of infectious origin, At least two of the following three clinical signs: Fever higher than 38 °C, Leukocytosis or leukopenia, Purulent secretions.
- Additionally, patients must meet at least one of the following criteria:
- Need for high-flow oxygen therapy (VM35 or FiO2 \>35%, Reservoir, HFNC, NIV, CPAP)
- Intubation (IOT)
- SOFA score ≥2 or PSI score \>85 (age 75 + IR)
- Horowitz index (PaO2/FiO2) \< 200
Who cannot join
- Lack of consent
- Age under 18 or over 90
- Pregnancy
- Life expectancy less than 3 months
- Hospital admission \>48 hours (hospital-acquired pneumonia - HAP)
- Rankin score ≥ 5
- Community-acquired pneumonia (CAP)
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Azienda ospedaliero universitaria careggi
Florence, Tuscany/Italy, 50122
Pelagatti Lorenzo, Dr, +39 3385917317, pelagattil@aou-careggi.toscana.it
About this study
Official title: HCAPPED I: HCAP - Pcr in Emergency Department. Early Multiplex PCR on Respiratory Samples From Patients With Pneumonia. A No-profit Observation Prospective Study
Prospective Observational Study (on Diagnostic Procedure) - Single-Center, Non-Profit.
A pilot study will be conducted on a prospective cohort of patients with HCAP (Healthcare-Associated Pneumonia). This study will be conducted on a single arm of patients. No control group or randomization is planned.
Read more
The use of syndromic molecular panels in pneumonias with risk factors for MDR (multidrug-resistant) pathogens, such as in patients with HCAP, has become common practice. However, the use of this tool is reserved for patients with severe forms of HCAP (PIRO\>2, at least moderate ARDS, and respiratory failure requiring high-flow oxygen during sepsis) (30), and it is not yet standardized by international guidelines. The decision to use this tool or not is currently at the clinician\'s discretion and is usually reserved for the severe forms mentioned above. The study aims to determine if the early use of this tool has a real benefit on the management of antibiotic therapy for these patients in terms of therapeutic changes compared to corporate and international guidelines.
Duration of patient enrollment: 1 year. Duration of the study: 1.5 years.
- Conditions
- Pneumonia, Bronchoalveolar Lavage, Antimicrobial Treatment, Sputum
- Keywords
- Bronchoalveolar lavage, Endotracheal Aspirate, Antimicrobial treatment, pneumonia, hcap, pcr multiplex, moleculas syndromic panel, bal, bas, eta, sputum
- Medical subject headings
- Pneumonia, De Lange Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| PCR multiplex (BIOFIRE® FILMARRAY® Pneumonia plus Panel) | The study seeks to assess the utility of molecular diagnostic tests in the emergency department for the microbiological etiological diagnosis of healthcare-associated pneumonia (HCAP). In clinical practice, patients with respiratory and infectious symptoms undergo blood sample collection for blood gas, chemical-physical, and culture analyses, urine samples for urinary antigen testing, and imaging diagnostics (X-ray, CT, ultrasound). Due to local infection control and surveillance measures, all patients with respiratory symptoms undergo a nasopharyngeal antigen test for SARS-CoV-2 as part of standard clinical practice. After completing the diagnostic work-up and diagnosing HCAP pneumonia, endobronchial samples are typically collected for multiplex PCR testing (BIOFIRE® FILMARRAY® Pneumonia plus Panel). Patients from whom these samples are collected are those needing high-flow oxygen therapy (VM35 or FiO2 higher, Reservoir, HFNC, NIV, CPAP), undergoing IOT, SOFA ≥2, PaO2/FiO2 < 200, o |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluate the impact of early use of multiplex PCR
The primary objective of the study is to evaluate the impact of early use of multiplex PCR on empirical antibiotic therapy. This will be measured by considering the percentage of cases in which the use of multiplex PCR alters the therapy ('escalation' and 'de-escalation') compared to local empirical antibiotic therapy guidelines within 24 hours of hospital admission.
Measured: perioperatively/periprocedurally
Secondary outcomes (9)
Time to Antibiotic Escalation or De-escalation
Measure the time from hospital admission to the escalation or de-escalation of antibiotic therapy.
Measured: up to 3 months
Length of Hospital Stay
Assess the total duration of the hospital stay.
Measured: up to 3 months
Need for Escalation of Supportive Therapy:
Evaluate the necessity for increased supportive therapy, defined as: a) Need for invasive or non-invasive ventilation b) Transfer to a higher level of care c) In-hospital mortality from any cause (complicated course)
Measured: up to 3 months
Duration of Antibiotic Therapy:
Track the length of time antibiotics are administered.
Measured: up to 3 months
De-escalation of Antibiotic Therapy
Assess the de-escalation of antibiotic therapy within the first 7 days of inclusion in the study.
Measured: 7 days from admission
Escalation of Antibiotic Therapy
Assess the escalation of antibiotic therapy within the first 7 days of inclusion in the study.
Measured: 7 days from admission
Identification of HCAP Etiology
Determine the cause of HCAP within the first 7 days of inclusion using all methods: multiplex PCR, culture tests, antigen detection, and serology.
Measured: 7 days from admission
In-hospital Mortality
Measure in-hospital mortality rates for pneumonia and all causes.
Measured: up to 3 months
30-day Mortality and Readmission
Measure mortality rates for pneumonia and all causes, and track readmissions within 30 days.
Measured: 30 days from discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2024
- Study start7 Jun 2024
- Primary completion7 Jul 2025 (estimated)
- Study completion7 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 93 participants (estimated)
- Target duration
- 90 Days
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero-Universitaria Careggi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peiman Nazerian, Azienda Ospedaliero-Universitaria Careggi
- Investigators
- Pelagatti Lorenzo, Dr, Principal investigator, AOU Careggi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06506617
- Sponsor's protocol ID
- CEAVC 26198_oss
- Acronym
- HCAPPED-I
- Status last verified
- Jul 2024
- First submitted
- 10 Jul 2024
- Last updated
- 17 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HCAPPED I: HCAP - Pcr in Emergency Department. Early Multiplex PCR on Respiratory Samples From Patients With Pneumonia. A No-profit Observation Prospective Study
- ClinicalTrials.gov ID
- NCT06506617
- Acronym / sponsor ID
- HCAPPED-I / CEAVC 26198_oss
- Conditions
- Pneumonia, Bronchoalveolar Lavage, Antimicrobial Treatment, Sputum
- Keywords
- Bronchoalveolar lavage, Endotracheal Aspirate, Antimicrobial treatment, pneumonia, hcap, pcr multiplex, moleculas syndromic panel, bal
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 93 participants (estimated)
- Lead sponsor
- Azienda Ospedaliero-Universitaria CareggiUniversity, hospital or other
- Study start
- 7 Jun 2024 (actual)
- Primary completion
- 7 Jul 2025 (estimated)
- Study completion
- 7 Jan 2026 (estimated)
- First posted
- 17 Jul 2024 (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.
Prospective Observational Study (on Diagnostic Procedure) - Single-Center, Non-Profit.
A pilot study will be conducted on a prospective cohort of patients with HCAP (Healthcare-Associated Pneumonia). This study will be conducted on a single arm of patients. No control group or randomization is planned.
The use of syndromic molecular panels in pneumonias with risk factors for MDR (multidrug-resistant) pathogens, such as in patients with HCAP, has become common practice. However, the use of this tool is reserved for patients with severe forms of HCAP (PIRO\>2, at least moderate ARDS, and respiratory failure requiring high-flow oxygen during sepsis) (30), and it is not yet standardized by international guidelines. The decision to use this tool or not is currently at the clinician\'s discretion and is usually reserved for the severe forms mentioned above. The study aims to determine if the early use of this tool has a real benefit on the management of antibiotic therapy for these patients in terms of therapeutic changes compared to corporate and international guidelines.
Duration of patient enrollment: 1 year. Duration of the study: 1.5 years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 90 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PCR multiplex (BIOFIRE® FILMARRAY® Pneumonia plus Panel) | – | –The study seeks to assess the utility of molecular diagnostic tests in the emergency department for the microbiological etiological diagnosis of healthcare-associated pneumonia (HCAP). In clinical practice, patients with respiratory and infectious symptoms undergo blood sample collection for blood gas, chemical-physical, and culture analyses, urine samples for urinary antigen testing, and imaging diagnostics (X-ray, CT, ultrasound). Due to local infection control and surveillance measures, all patients with respiratory symptoms undergo a nasopharyngeal antigen test for SARS-CoV-2 as part of standard clinical practice. After completing the diagnostic work-up and diagnosing HCAP pneumonia, endobronchial samples are typically collected for multiplex PCR testing (BIOFIRE® FILMARRAY® Pneumonia plus Panel). Patients from whom these samples are collected are those needing high-flow oxygen therapy (VM35 or FiO2 higher, Reservoir, HFNC, NIV, CPAP), undergoing IOT, SOFA ≥2, PaO2/FiO2 < 200, o |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients over the age of 18 who undergo bronchoalveolar lavage (BAL) in the Emergency Department (DEA), with a Rankin score of less than 5, and who are admitted to the Emergency Department with a diagnosis of healthcare-associated pneumonia (HCAP) of bacterial, viral, or fungal origin. A patient is considered to have HCAP if they meet any of the following conditions: Hospitalized in an acute care hospital for two or more days within 90 days of symptom onset Residing in a nursing home or long-term care facility Received intravenous antibiotic therapy, chemotherapy, or wound care within the past 30 days Attended a hospital or hemodialysis clinic within the past 30 days for medical reasons, visits, or day services
Key inclusion criteria (6 listed)
- All patients over the age of 18 who undergo bronchoalveolar lavage (BAL) in the Emergency Department (DEA), with a Rankin score of less than 5, and who are admitted to the Emergency Department with a diagnosis of healthcare-associated pneumonia (HCAP) of bacterial, viral, or fungal origin. The diagnosis must be confirmed by clinical and radiological criteria according to the IDSA guidelines, which include: New pulmonary infiltrate on chest X-ray, Evidence that the infiltrate is of infectious origin, At least two of the following three clinical signs: Fever higher than 38 °C, Leukocytosis or leukopenia, Purulent secretions.
- Need for high-flow oxygen therapy (VM35 or FiO2 \>35%, Reservoir, HFNC, NIV, CPAP)
- Intubation (IOT)
- SOFA score ≥2 or PSI score \>85 (age 75 + IR)
- Horowitz index (PaO2/FiO2) \< 200
Key exclusion criteria (7 listed)
- Lack of consent
- Age under 18 or over 90
- Pregnancy
- Life expectancy less than 3 months
- Hospital admission \>48 hours (hospital-acquired pneumonia - HAP)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
evaluate the impact of early use of multiplex PCR
Time frame: perioperatively/periprocedurally
The primary objective of the study is to evaluate the impact of early use of multiplex PCR on empirical antibiotic therapy. This will be measured by considering the percentage of cases in which the use of multiplex PCR alters the therapy ('escalation' and 'de-escalation') compared to local empirical antibiotic therapy guidelines within 24 hours of hospital admission.
9 secondary outcomes
Time to Antibiotic Escalation or De-escalation
Time frame: up to 3 months
Length of Hospital Stay
Time frame: up to 3 months
Need for Escalation of Supportive Therapy:
Time frame: up to 3 months
Duration of Antibiotic Therapy:
Time frame: up to 3 months
De-escalation of Antibiotic Therapy
Time frame: 7 days from admission
Escalation of Antibiotic Therapy
Time frame: 7 days from admission
Identification of HCAP Etiology
Time frame: 7 days from admission
In-hospital Mortality
Time frame: up to 3 months
30-day Mortality and Readmission
Time frame: 30 days from discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2024.
- Individual participant dataSharing planned: Undecided
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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.
Pelagatti Lorenzo, Dr principal investigator
AOU Careggi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumonia and Bronchoalveolar Lavage, run by Azienda Ospedaliero-Universitaria Careggi at 1 site in Italy.
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 6 inclusion and 7 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 17 Jul 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 Italy. 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 Pelagatti Lorenzo, Dr (+393385917317, pelagattil@aou-careggi.toscana.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evaluate the impact of early use of multiplex PCR (time frame: perioperatively/periprocedurally). 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 17 Jul 2024.