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Impact of Comprehensive Molecular Tests on Antimicrobial Stewardship in Community-acquired Pneumonia (RADICAP)

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ClinicalTrials.gov Identifier: NCT04158492
Recruitment Status : Recruiting
First Posted : November 8, 2019
Last Update Posted : March 6, 2020
Sponsor:
Collaborators:
Fundació La Marató de TV3
Department of Health, Generalitat de Catalunya
Information provided by (Responsible Party):
Jordi Carratala, Hospital Universitari de Bellvitge

Brief 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 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.


Condition or disease Intervention/treatment Phase
Community-acquired Pneumonia Diagnostic Test: real-time multiplex PCR Diagnostic Test: Standard diagnostic procedures Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 440 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Controlled, open-label clinical trial with two parallel groups (1:1) settled in two tertiary care hospitals
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Impact of Comprehensive Molecular Tests on Antimicrobial Stewardship in Community-acquired Pneumonia: an Open, Controlled and Randomized Clinical Trial
Actual Study Start Date : February 20, 2020
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Standard diagnostic tests
Patients who will undergo only the standard diagnostic procedures
Diagnostic Test: 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).
Diagnostic Test: real-time multiplex PCR
Patients will be randomly assigned to receive experimental diagnosis (comprehensive molecular testing added to routine microbiological testing) AND standard diagnosis microbiological procedures




Primary Outcome Measures :
  1. Number of DOT/1000 patients [ Time Frame: Up to 30±5 days after hospital discharge ]
    Number of days of antibiotic therapy per 1000 patient-days


Secondary Outcome Measures :
  1. Number of days with intravenous antibiotic treatment. [ Time Frame: Up to 30±5 days after hospital discharge ]
    Number of days of intravenous antibiotic treatment

  2. 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

  3. Number of days until antimicrobial monotherapy [ Time Frame: Up to 30±5 days after hospital discharge ]
    Number of days untilt antimicrobial monotherapy

  4. Number of days until etiological diagnosis [ Time Frame: Up to 30±5 days after hospital discharge ]
    Number of days until detection of the causal agent

  5. Number of days of Oxygen treatment [ Time Frame: Up to 30±5 days after hospital discharge ]
    Days of oxygen treatment

  6. Number of days of non-invasive ventilation [ Time Frame: Up to 30±5 days after hospital discharge ]
    Days of invasive or non-invasive mechanical ventilation

  7. Number of days of hospital admission [ Time Frame: Up to hospital discharge - a medium of 5 days ]
    Number of days of hospital admission

  8. Rate of readmissions [ Time Frame: Up to 30±5 days after hospital discharge ]
    Rate of patients who are readmitted after hospital discharge

  9. Rate of complicated community-acquired pneumonia (CAP) [ Time Frame: Up to 30±5 days after hospital discharge ]
    Rate of complications related to CAP

  10. Rate of general complications [ Time Frame: Up to 30±5 days after hospital discharge ]
    Patients with medical complications not directly related to CAP until the end of the clinical trial.

  11. Number of adverse events [ Time Frame: Up to 30±5 days after hospital discharge ]
    Number of total adverse events.

  12. Number of adverse events related to antimicrobials [ Time Frame: Up to 30±5 days after hospital discharge ]
    Number of adverse events related to antibiotic therapy.

  13. Number of participants with Clostridium difficile infection [ Time Frame: Up to 30±5 days after hospital discharge ]
    Number of patients diagnosed with Clostridium difficile infection during the clinical trial.

  14. Phlebitis rate [ Time Frame: Up to 30±5 days after hospital discharge ]
    Number of patients with phlebitis resulting from the use of intravenous drugs.

  15. Early mortality rate [ Time Frame: Up tp 5 days after randomization ]
    Number of patients deceased 5 days after the randomization

  16. 30 day case-fatality rate [ Time Frame: Up to 30±5 days after randomization ]
    Number of patients deceased 30±5 days after randomization

  17. CAP-related fatality rate [ Time Frame: Up to 30±5 days after hospital discharge ]
    Number of patients Deceased patients, related to CAP during the clinical trial

  18. All-cause fatality rate [ Time Frame: Up to 30±5 days after hospital discharge ]
    Number of patients who died from any cause during the clinical trial



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04158492


Contacts
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Contact: Jordi Carratalà Fernández, PhD 932607500 ext 5778 jordicarratala@bellvitgehospital.com
Contact: Gabriela Abelenda Alonso, PhD 932607500 ext 2075 gabi.abelenda.alonso@gmail.com

Locations
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Spain
SCIAS Hospital de Barcelona Recruiting
Barcelona, Cataluña, Spain, 08022
Contact: Yolanda Meije, PhD    0034932542400    ymeije@scias.com   
Principal Investigator: Yolanda Meije, PhD         
Sub-Investigator: Lucía Ortega, PhD         
Sub-Investigator: Mercedes Clemente, MD         
Hospital de Bellvitge Recruiting
Barcelona, Spain, 08036
Contact: Gabriela Abelenda Alonso, MD    0034932602487    gabi.abelenda.alonso@gmail.com   
Contact: Jordi Caratalà, PhD, Prof    0034932602487      
Principal Investigator: Jordi Carratalà, PhD         
Sub-Investigator: Gabriela Abelenda-Alonso, MD         
Sub-Investigator: Alexander Rombauts, MD         
Sub-Investigator: Carlota Gudiol, PhD         
Sub-Investigator: Carmen Ardanuy, PhD         
Sub-Investigator: Jordi Niubó, PhD         
Sub-Investigator: Ariadna Padullés, PhD         
Sub-Investigator: Sebastián Videla, PhD         
Sub-Investigator: Christian Tebé, PhD         
Sponsors and Collaborators
Hospital Universitari de Bellvitge
Fundació La Marató de TV3
Department of Health, Generalitat de Catalunya
Investigators
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Study Director: Jordi Carratalà Fernández, PhD Institut d'Investigació Biomèdica de Bellvitge
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Responsible Party: Jordi Carratala, Head of Infectious Diseases, Hospital Universitari de Bellvitge
ClinicalTrials.gov Identifier: NCT04158492    
Other Study ID Numbers: HUB-INF-RADICAP
First Posted: November 8, 2019    Key Record Dates
Last Update Posted: March 6, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data will be made available after evaluating individual request.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jordi Carratala, Hospital Universitari de Bellvitge:
antimicrobial stewardship
point-of-care test
comprehensive molecular tests
multiple PCR
Additional relevant MeSH terms:
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Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections