Community-acquired PneumoniaRADICAPNCT04158492
Impact of Comprehensive Molecular Tests on Antimicrobial Stewardship in Community-acquired Pneumonia
A study testing real-time multiplex PCR and Standard diagnostic procedures in people with Community-acquired Pneumonia, run by Hospital Universitari de Bellvitge at 4 sites in Spain.
Trial summary
Background: Community-acquired pneumonia (CAP) continues to be a major health problem with significant mortality and it's one of the main causes of antibiotic prescription. Antibiotic overuse is a key driver of antimicrobial resistance and exposes patients to an increased risk of other antibiotic-related adverse… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Community-acquired Pneumonia
- What is being tested?
- real-time multiplex PCR and Standard diagnostic procedures
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 242 participants
- Where
- 4 sitesSpain
- Study dates
- 20 Feb 2020to 24 Apr 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (18 years of age or older), of both sexes, hospitalized with a diagnosis of CAP in the first 24 hours of the admission.
- Patient or his legal representative gives the informed consent
Who cannot join
- Patient with acute infection by SARS-CoV-2 being this defined as:
- Clinic of COVID-19 compatible, PCR positive for SARS-CoV-2 and negative serology for SARS-CoV-2.
- OR
- COVID-19 clinic compatible, PCR positive for SARS-CoV-2 (in the last 60 days) and positive serology for SARS-CoV-2.
- Pregnancy and / or nursing.
- Severe immunocompromised patients (chemotherapy or radiotherapy in the previous 90 days, use of immunosuppressive drugs, chronic use of corticosteroids at a minimum dose of 15 mg / day in the last two weeks, transplantation of hematopoietic progenitors, solid organ transplant, patients with HIV and CD4 count ≤ 200 cells / mm3).
- Imminent death (life expectancy ≤ 24 hours).
- Participation in another clinical trial of pharmacological treatment during the previous 3 months.
Trial locations and contacts
4 sites in 1 country.
Spain4 sites
Hospital Germans Trias i Pujol
Badalona, Barcelona, 08916
SCIAS Hospital de Barcelona
Barcelona, Catalonia, 08022
Hospital de Bellvitge
Barcelona, 08036
Moisés Broggi University Hospital
Sant Joan Despí, Barcelona, 08970
About this study
Official title: Impact of Comprehensive Molecular Tests on Antimicrobial Stewardship in Community-acquired Pneumonia: an Open, Controlled and Randomized Clinical Trial
Background: Community-acquired pneumonia (CAP) continues to be a major health problem with significant mortality and it's one of the main causes of antibiotic prescription. Antibiotic overuse is a key driver of antimicrobial resistance and exposes patients to an increased risk of other antibiotic-related adverse events. The investigators aim to assess if rapid molecular tests are an effective tool to reduce antibiotic use in CAP compared to routine microbiological testing.
Design: Randomized, controlled, open-label clinical trial with two parallel groups (1:1) settled in a two-year multicenter, two tertiary care hospitals, between 2019 and 2021. Eligible participants will be non-severely immunosuppressed adult patients hospitalized for CAP through the emergency department. Primary endpoint will be antibiotic consumption measured by days of antibiotic therapy (DOT) per 1000 patient-days. Secondary end points will be: de-escalation to narrower antibiotic treatment, time to switch from intravenous to oral antibiotics, antibiotic-related side effects, length of hospital stay, days until clinical stability, need for ICU admission, need for hospital readmission in the 30 days after randomization, death from any cause in the 30 days after randomization. Patients will be randomly assigned to receive experimental diagnosis (comprehensive molecular testing added to routine microbiological testing) or standard diagnosis (only microbiological routine testing). A total of 220 patients are estimated in the experimental arm (undergoing comprehensive molecular testing) and 220 control subjects (undergoing routine testing) to be able to reject the null hypothesis that experimental and control groups have equal DOT per 1000 patients-days with a probability above 0.8.
Discussion: Comprehensive molecular tests could be a key tool in the optimization of etiological diagnostics in CAP and, therefore, a key element in antimicrobial stewardship programs developed to improve safety and antibiotic use in CAP.
- Conditions
- Community-acquired Pneumonia
- Being tested
- real-time multiplex PCR, Standard diagnostic procedures
- Keywords
- antimicrobial stewardship, point-of-care test, comprehensive molecular tests, multiple PCR
- Medical subject headings
- Community-Acquired Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
real-time multiplex PCRDiagnostic test
Patients will be randomly assigned to receive experimental diagnosis (comprehensive molecular testing added to routine microbiological testing) AND standard diagnosis microbiological procedures
Standard diagnostic proceduresDiagnostic test
Patients who will undergo only the standard microbiological diagnostic procedures: blood cultures, Gram stain and culture sputum when possible, Gram and pleural fluid culture when appropriate, urine determination of the pneumococcal and Legionella pneumophila serogroup antigens type 1. A serological study will be carried out for the etiological agents of atypical pneumonia in the acute and convalescent phases of the infection.
| Study group | Role | What they receive |
|---|---|---|
| Standard diagnostic tests | Active comparator | Patients who will undergo only the standard diagnostic procedures Receives: Diagnostic Test: Standard diagnostic procedures |
| Experimental + standard diagnostic tests | Experimental | Patients will undergo described standard diagnostic procedures and in addition, real-time multiplex Protein Chain Reaction (PCR, FilmArray Pneumonia panel Plus ™, Biofire, BioMérieux). Receives: Diagnostic Test: real-time multiplex PCR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of DOT
Number of days of antibiotic therapy
Measured: Up to 30±5 days after hospital discharge
Secondary outcomes (19)
Number of days with intravenous antibiotic treatment.
Number of days of intravenous antibiotic treatment
Measured: Up to 30±5 days after hospital discharge
Number of days until de-escalation
Number of days until de-escalation of antibiotic treatment to another of narrower spectrum
Measured: Up to 30±5 days after hospital discharge
Number of days until antimicrobial monotherapy
Number of days untilt antimicrobial monotherapy
Measured: Up to 30±5 days after hospital discharge
Number of days until etiological diagnosis
Number of days until detection of the causal agent
Measured: Up to 30±5 days after hospital discharge
Number of days of Oxygen treatment
Days of oxygen treatment
Measured: Up to 30±5 days after hospital discharge
Number of days of non-invasive ventilation
Days of invasive or non-invasive mechanical ventilation
Measured: Up to 30±5 days after hospital discharge
Number of days of hospital admission
Number of days of hospital admission
Measured: Up to hospital discharge - a medium of 5 days
Rate of readmissions
Rate of patients who are readmitted after hospital discharge
Measured: Up to 30±5 days after hospital discharge
Rate of complicated community-acquired pneumonia (CAP)
Rate of complications related to CAP
Measured: Up to 30±5 days after hospital discharge
Rate of general complications
Patients with medical complications not directly related to CAP until the end of the clinical trial.
Measured: Up to 30±5 days after hospital discharge
Number of adverse events
Number of total adverse events.
Measured: Up to 30±5 days after hospital discharge
Number of adverse events related to antimicrobials
Number of adverse events related to antibiotic therapy.
Measured: Up to 30±5 days after hospital discharge
Number of participants with Clostridium difficile infection
Number of patients diagnosed with Clostridium difficile infection during the clinical trial.
Measured: Up to 30±5 days after hospital discharge
Phlebitis rate
Number of patients with phlebitis resulting from the use of intravenous drugs.
Measured: Up to 30±5 days after hospital discharge
Early mortality rate
Number of patients deceased 5 days after the randomization
Measured: Up tp 5 days after randomization
30 day case-fatality rate
Number of patients deceased 30±5 days after randomization
Measured: Up to 30±5 days after randomization
CAP-related fatality rate
Number of patients Deceased patients, related to CAP during the clinical trial
Measured: Up to 30±5 days after hospital discharge
All-cause fatality rate
Number of patients who died from any cause during the clinical trial
Measured: Up to 30±5 days after hospital discharge
Number of DOT per 1000 patients-day
Number of Days of antibiotic treatment per 1000 patients-day
Measured: Up to 30±5 days after hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2019
- Study start20 Feb 2020
- Primary completion24 Apr 2023
- Study completion24 Apr 2023
Why it stopped: Futility
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Controlled, open-label clinical trial with two parallel groups (1:1) settled in two tertiary care hospitals
- Masking
- None (open label)
- Enrolment
- 242 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitari de Bellvitge
- Sponsor type
- University, hospital or other
- Collaborators
- Fundació La Marató de TV3, Department of Health, Generalitat de Catalunya
- Responsible party
- Principal investigator, Jordi Carratala, Hospital Universitari de Bellvitge
- Investigators
- Jordi Carratalà Fernández, PhD, Study director, Institut d'Investigació Biomèdica de Bellvitge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04158492
- Sponsor's protocol ID
- HUB-INF-RADICAP
- Acronym
- RADICAP
- Status last verified
- Apr 2023
- First submitted
- 28 Oct 2019
- Last updated
- 28 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be made available after evaluating individual request.
Publications
Abelenda-Alonso G, Calatayud L, Rombauts A, Meije Y, Oriol I, Sopena N, Padulles A, Niubo J, Duarte A, Llaberia J, Aranda J, Gudiol C, Satorra P, Tebe C, Ardanuy C, Carratala J. Multiplex real-time PCR in non-invasive respiratory samples to reduce antibiotic use in community-acquired pneumonia: a randomised trial. Nat Commun. 2024 Aug 17;15(1):7098. doi: 10.1038/s41467-024-51547-8.
PubMed 39154071Kerneis S, Visseaux B, Armand-Lefevre L, Timsit JF. Molecular diagnostic methods for pneumonia: how can they be applied in practice? Curr Opin Infect Dis. 2021 Apr 1;34(2):118-125. doi: 10.1097/QCO.0000000000000713.
PubMed 33395094Abelenda-Alonso G, Rombauts A, Gudiol C, Meije Y, Clemente M, Ortega L, Ardanuy C, Niubo J, Padulles A, Videla S, Tebe C, Carratala J. Impact of comprehensive molecular testing to reduce antibiotic use in community-acquired pneumonia (RADICAP): a randomised, controlled, phase IV clinical trial protocol. BMJ Open. 2020 Aug 20;10(8):e038957. doi: 10.1136/bmjopen-2020-038957.
PubMed 32819999
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Comprehensive Molecular Tests on Antimicrobial Stewardship in Community-acquired Pneumonia: an Open, Controlled and Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04158492
- Acronym / sponsor ID
- RADICAP / HUB-INF-RADICAP
- Conditions
- Community-acquired Pneumonia
- Keywords
- antimicrobial stewardship, point-of-care test, comprehensive molecular tests, multiple PCR
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Futility
- Enrolment
- 242 participants (actual)
- Lead sponsor
- Hospital Universitari de BellvitgeUniversity, hospital or other
- Collaborators
- Fundació La Marató de TV3, Department of Health, Generalitat de Catalunya
- Study start
- 20 Feb 2020 (actual)
- Primary completion
- 24 Apr 2023 (actual)
- Study completion
- 24 Apr 2023 (actual)
- First posted
- 8 Nov 2019 (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.
Background: Community-acquired pneumonia (CAP) continues to be a major health problem with significant mortality and it's one of the main causes of antibiotic prescription. Antibiotic overuse is a key driver of antimicrobial resistance and exposes patients to an increased risk of other antibiotic-related adverse events. The investigators aim to assess if rapid molecular tests are an effective tool to reduce antibiotic use in CAP compared to routine microbiological testing.
Design: Randomized, controlled, open-label clinical trial with two parallel groups (1:1) settled in a two-year multicenter, two tertiary care hospitals, between 2019 and 2021. Eligible participants will be non-severely immunosuppressed adult patients hospitalized for CAP through the emergency department. Primary endpoint will be antibiotic consumption measured by days of antibiotic therapy (DOT) per 1000 patient-days. Secondary end points will be: de-escalation to narrower antibiotic treatment, time to switch from intravenous to oral antibiotics, antibiotic-related side effects, length of hospital stay, days until clinical stability, need for ICU admission, need for hospital readmission in the 30 days after randomization, death from any cause in the 30 days after randomization. Patients will be randomly assigned to receive experimental diagnosis (comprehensive molecular testing added to routine microbiological testing) or standard diagnosis (only microbiological routine testing). A total of 220 patients are estimated in the experimental arm (undergoing comprehensive molecular testing) and 220 control subjects (undergoing routine testing) to be able to reject the null hypothesis that experimental and control groups have equal DOT per 1000 patients-days with a probability above 0.8.
Discussion: Comprehensive molecular tests could be a key tool in the optimization of etiological diagnostics in CAP and, therefore, a key element in antimicrobial stewardship programs developed to improve safety and antibiotic use in CAP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Controlled, open-label clinical trial with two parallel groups (1:1) settled in two tertiary care hospitals
| Arm | Type | Receives |
|---|---|---|
| Standard diagnostic tests | Active comparator | Diagnostic Test: Standard diagnostic proceduresPatients who will undergo only the standard diagnostic procedures |
| Experimental + standard diagnostic tests | Experimental | Diagnostic Test: real-time multiplex PCRPatients will undergo described standard diagnostic procedures and in addition, real-time multiplex Protein Chain Reaction (PCR, FilmArray Pneumonia panel Plus ™, Biofire, BioMérieux). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients (18 years of age or older), of both sexes, hospitalized with a diagnosis of CAP in the first 24 hours of the admission.
- Patient or his legal representative gives the informed consent
Key exclusion criteria (8 listed)
- Patient with acute infection by SARS-CoV-2 being this defined as:
- OR
- COVID-19 clinic compatible, PCR positive for SARS-CoV-2 (in the last 60 days) and positive serology for SARS-CoV-2.
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 |
|---|---|---|
| real-time multiplex PCRPatients will be randomly assigned to receive experimental diagnosis (comprehensive molecular testing added to routine microbiological testing) AND standard diagnosis microbiological procedures | Diagnostic test | Experimental + standard diagnostic tests |
| Standard diagnostic proceduresPatients who will undergo only the standard microbiological diagnostic procedures: blood cultures, Gram stain and culture sputum when possible, Gram and pleural fluid culture when appropriate, urine determination of the pneumococcal and Legionella pneumophila serogroup antigens type 1. A serological study will be carried out for the etiological agents of atypical pneumonia in the acute and convalescent phases of the infection. | Diagnostic test | Standard diagnostic tests |
Primary outcome
Number of DOT
Time frame: Up to 30±5 days after hospital discharge
Number of days of antibiotic therapy
19 secondary outcomes
Number of days with intravenous antibiotic treatment.
Time frame: Up to 30±5 days after hospital discharge
Number of days until de-escalation
Time frame: Up to 30±5 days after hospital discharge
Number of days until antimicrobial monotherapy
Time frame: Up to 30±5 days after hospital discharge
Number of days until etiological diagnosis
Time frame: Up to 30±5 days after hospital discharge
Number of days of Oxygen treatment
Time frame: Up to 30±5 days after hospital discharge
Number of days of non-invasive ventilation
Time frame: Up to 30±5 days after hospital discharge
Number of days of hospital admission
Time frame: Up to hospital discharge - a medium of 5 days
Rate of readmissions
Time frame: Up to 30±5 days after hospital discharge
Rate of complicated community-acquired pneumonia (CAP)
Time frame: Up to 30±5 days after hospital discharge
Rate of general complications
Time frame: Up to 30±5 days after hospital discharge
Number of adverse events
Time frame: Up to 30±5 days after hospital discharge
Number of adverse events related to antimicrobials
Time frame: Up to 30±5 days after hospital discharge
Number of participants with Clostridium difficile infection
Time frame: Up to 30±5 days after hospital discharge
Phlebitis rate
Time frame: Up to 30±5 days after hospital discharge
Early mortality rate
Time frame: Up tp 5 days after randomization
30 day case-fatality rate
Time frame: Up to 30±5 days after randomization
CAP-related fatality rate
Time frame: Up to 30±5 days after hospital discharge
All-cause fatality rate
Time frame: Up to 30±5 days after hospital discharge
Number of DOT per 1000 patients-day
Time frame: Up to 30±5 days after hospital discharge
Results and safety
The study was stopped early (reason given: Futility). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2023.
- Derived from this study: PubMed 39154071Abelenda-Alonso G, Calatayud L, Rombauts A, Meije Y, Oriol I, Sopena N, Padulles A, Niubo J, Duarte A, Llaberia J, Aranda J, Gudiol C, Satorra P, Tebe C, Ardanuy C, Carratala J. Multiplex real-time PCR in non-invasive respiratory samples to reduce antibiotic use in community-acquired pneumonia: a randomised trial. Nat Commun. 2024 Aug 17;15(1):7098. doi: 10.1038/s41467-024-51547-8.
- Derived from this study: PubMed 33395094Kerneis S, Visseaux B, Armand-Lefevre L, Timsit JF. Molecular diagnostic methods for pneumonia: how can they be applied in practice? Curr Opin Infect Dis. 2021 Apr 1;34(2):118-125. doi: 10.1097/QCO.0000000000000713.
- Derived from this study: PubMed 32819999Abelenda-Alonso G, Rombauts A, Gudiol C, Meije Y, Clemente M, Ortega L, Ardanuy C, Niubo J, Padulles A, Videla S, Tebe C, Carratala J. Impact of comprehensive molecular testing to reduce antibiotic use in community-acquired pneumonia (RADICAP): a randomised, controlled, phase IV clinical trial protocol. BMJ Open. 2020 Aug 20;10(8):e038957. doi: 10.1136/bmjopen-2020-038957.
- Individual participant dataSharing planned: No. Data will be made available after evaluating individual request.
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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.
Jordi Carratalà Fernández, PhD study director
Institut d'Investigació Biomèdica de Bellvitge
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing real-time multiplex PCR and Standard diagnostic procedures in people with Community-acquired Pneumonia, run by Hospital Universitari de Bellvitge at 4 sites 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 2 inclusion and 8 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: stopped early, as of the sponsor's last update on 28 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
The study was stopped early (reason given: Futility). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of DOT (time frame: Up to 30±5 days after hospital discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04158492, which also lists 3 linked publications.
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 28 Apr 2023.