- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04158492
Impact of Comprehensive Molecular Tests on Antimicrobial Stewardship in Community-acquired Pneumonia (RADICAP)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jordi Carratalà Fernández, PhD
- Phone Number: 5778 932607500
- Email: jordicarratala@bellvitgehospital.com
Study Contact Backup
- Name: Gabriela Abelenda Alonso, PhD
- Phone Number: 2075 932607500
- Email: gabi.abelenda.alonso@gmail.com
Study Locations
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-
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Barcelona, Spain, 08036
- Hospital de Bellvitge
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Barcelona
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Badalona, Barcelona, Spain, 08916
- Hospital Germans Trias i Pujol
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Sant Joan Despí, Barcelona, Spain, 08970
- Moisés Broggi University Hospital
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Cataluña
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Barcelona, Cataluña, Spain, 08022
- SCIAS Hospital de Barcelona
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Standard diagnostic tests
Patients who will undergo only the standard diagnostic procedures
|
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.
|
Experimental: Experimental + standard diagnostic tests
Patients will undergo described standard diagnostic procedures and in addition, real-time multiplex Protein Chain Reaction (PCR, FilmArray Pneumonia panel Plus ™, Biofire, BioMérieux).
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Patients will be randomly assigned to receive experimental diagnosis (comprehensive molecular testing added to routine microbiological testing) AND standard diagnosis microbiological procedures
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of DOT
Time Frame: Up to 30±5 days after hospital discharge
|
Number of days of antibiotic therapy
|
Up to 30±5 days after hospital discharge
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of days with intravenous antibiotic treatment.
Time Frame: Up to 30±5 days after hospital discharge
|
Number of days of intravenous antibiotic treatment
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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 de-escalation of antibiotic treatment to another of narrower spectrum
|
Up to 30±5 days after hospital discharge
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Number of days until antimicrobial monotherapy
Time Frame: Up to 30±5 days after hospital discharge
|
Number of days untilt antimicrobial monotherapy
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Up to 30±5 days after hospital discharge
|
Number of days until etiological diagnosis
Time Frame: Up to 30±5 days after hospital discharge
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Number of days until detection of the causal agent
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Up to 30±5 days after hospital discharge
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Number of days of Oxygen treatment
Time Frame: Up to 30±5 days after hospital discharge
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Days of oxygen treatment
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Up to 30±5 days after hospital discharge
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Number of days of non-invasive ventilation
Time Frame: Up to 30±5 days after hospital discharge
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Days of invasive or non-invasive mechanical ventilation
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Up to 30±5 days after hospital discharge
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Number of days of hospital admission
Time Frame: Up to hospital discharge - a medium of 5 days
|
Number of days of hospital admission
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Up to hospital discharge - a medium of 5 days
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Rate of readmissions
Time Frame: Up to 30±5 days after hospital discharge
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Rate of patients who are readmitted after hospital discharge
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Up to 30±5 days after hospital discharge
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Rate of complicated community-acquired pneumonia (CAP)
Time Frame: Up to 30±5 days after hospital discharge
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Rate of complications related to CAP
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Up to 30±5 days after hospital discharge
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Rate of general complications
Time Frame: Up to 30±5 days after hospital discharge
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Patients with medical complications not directly related to CAP until the end of the clinical trial.
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Up to 30±5 days after hospital discharge
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Number of adverse events
Time Frame: Up to 30±5 days after hospital discharge
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Number of total adverse events.
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Up to 30±5 days after hospital discharge
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Number of adverse events related to antimicrobials
Time Frame: Up to 30±5 days after hospital discharge
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Number of adverse events related to antibiotic therapy.
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Up to 30±5 days after hospital discharge
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Number of participants with Clostridium difficile infection
Time Frame: Up to 30±5 days after hospital discharge
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Number of patients diagnosed with Clostridium difficile infection during the clinical trial.
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Up to 30±5 days after hospital discharge
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Phlebitis rate
Time Frame: Up to 30±5 days after hospital discharge
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Number of patients with phlebitis resulting from the use of intravenous drugs.
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Up to 30±5 days after hospital discharge
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Early mortality rate
Time Frame: Up tp 5 days after randomization
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Number of patients deceased 5 days after the randomization
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Up tp 5 days after randomization
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30 day case-fatality rate
Time Frame: Up to 30±5 days after randomization
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Number of patients deceased 30±5 days after randomization
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Up to 30±5 days after randomization
|
CAP-related fatality rate
Time Frame: Up to 30±5 days after hospital discharge
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Number of patients Deceased patients, related to CAP during the clinical trial
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Up to 30±5 days after hospital discharge
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All-cause fatality rate
Time Frame: Up to 30±5 days after hospital discharge
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Number of patients who died from any cause during the clinical trial
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Up to 30±5 days after hospital discharge
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Number of DOT per 1000 patients-day
Time Frame: Up to 30±5 days after hospital discharge
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Number of Days of antibiotic treatment per 1000 patients-day
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Up to 30±5 days after hospital discharge
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Collaborators and Investigators
Investigators
- Study Director: Jordi Carratalà Fernández, PhD, Institut d'Investigació Biomèdica de Bellvitge
Publications and helpful links
General Publications
- Kerneis 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.
- Abelenda-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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HUB-INF-RADICAP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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