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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||440 participants|
|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)|
|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|
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
- 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
- Number of days with intravenous antibiotic treatment. [ Time Frame: Up to 30±5 days after hospital discharge ]Number of days of intravenous antibiotic treatment
- 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
- Number of days until antimicrobial monotherapy [ Time Frame: Up to 30±5 days after hospital discharge ]Number of days untilt antimicrobial monotherapy
- 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
- Number of days of Oxygen treatment [ Time Frame: Up to 30±5 days after hospital discharge ]Days of oxygen treatment
- 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
- Number of days of hospital admission [ Time Frame: Up to hospital discharge - a medium of 5 days ]Number of days of hospital admission
- Rate of readmissions [ Time Frame: Up to 30±5 days after hospital discharge ]Rate of patients who are readmitted after hospital discharge
- Rate of complicated community-acquired pneumonia (CAP) [ Time Frame: Up to 30±5 days after hospital discharge ]Rate of complications related to CAP
- 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.
- Number of adverse events [ Time Frame: Up to 30±5 days after hospital discharge ]Number of total adverse events.
- 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.
- 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.
- Phlebitis rate [ Time Frame: Up to 30±5 days after hospital discharge ]Number of patients with phlebitis resulting from the use of intravenous drugs.
- Early mortality rate [ Time Frame: Up tp 5 days after randomization ]Number of patients deceased 5 days after the randomization
- 30 day case-fatality rate [ Time Frame: Up to 30±5 days after randomization ]Number of patients deceased 30±5 days after randomization
- 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
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04158492
|Contact: Jordi Carratalà Fernández, PhD||932607500 ext firstname.lastname@example.org|
|Contact: Gabriela Abelenda Alonso, PhD||932607500 ext email@example.com|
|SCIAS Hospital de Barcelona||Recruiting|
|Barcelona, Cataluña, Spain, 08022|
|Contact: Yolanda Meije, PhD 0034932542400 firstname.lastname@example.org|
|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 email@example.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|
|Study Director:||Jordi Carratalà Fernández, PhD||Institut d'Investigació Biomèdica de Bellvitge|