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โ† Trials
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EaRly impAct theraPy With Ceftazidime-avibactam Via rapID Diagnostics

RecruitingPhase 4Ages 18 Years - anyAllNational University of Singapore
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In plain words

What the trial is, and whether it could suit you

RAPID is an investigator initiated Phase 4, multinational, multicentre, open-label, randomised controlled superiority trial evaluating the clinical impact of rapid microbiological diagnostics combined with antimicrobial stewardship and early targeted antibiotic therapy compared with standard-of-care diagnostics and antibiotics. Hospitalised adult patients with bloodstream infections, hospital-acquired pneumonia or ventilator-associated pneumonia are randomised in a 1:1 ratio to the intervention or control arm. The main analysis population comprises patients with infections caused by Pseudomonas aeruginosa or carbapenem-resistant Enterobacterales. A secondary analysis population includes patients with infections caused by other specified multidrug-resistant Gram-negative organisms. Patients will be randomised to either a control or intervention arm. Patients randomised to the intervent

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Adult patients aged 18 years or older (21 years or older in Singapore) who meet at least one of the following criteria: * At risk of developing bloodstream infection, hospital-acquired pneumonia (HAP), or ventilator-associated pneumonia (VAP) due to Pseudomonas aeruginosa or carbapenem-resistant Enterobacterales; OR * Blood culture bottles showing Gram-negative bacilli on Gram stain; OR * Suspected HAP or VAP with respiratory specimens showing Gram-negative bacteria on Gram stain. 2. For randomisation, all of the following criteria must be fulfilled: * Written informed consent obtained from the participant or their authorised representative. * An appropriate blood or respiratory specimen received by the participating microbiology laboratory, with Gram-negative bacilli detected on Gram stain. * Patients with HAP or VAP must fulfil the US Centers for Disease Control and Prevention National Healthcare Safety Network (CDC NHSN) criteria. * No exclusion criteria are met. Exclusion Criteria: 1. Refractory shock or comorbid condition such that the patient is not expected to survive more than 48 hours. 2. Suspected catheter-related bloodstream infection where the implicated vascular catheter cannot be removed. 3. Treatment is not intended to cure the infection. 4. Infection requiring prolonged antibiotic treatment (more than two weeks). 5. Incarceration in a correctional facility. 6. Previous enrolment in the RAPID trial within the preceding 60 days. 7. Patients younger than 18 years (younger than 21 years in Singapore).
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What it tests

  • Rapid Diagnostics
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Where

21 sites
Christian Medical College Vellore
Vellore, India
Hospital Pulau Pinang
George Town, Malaysia
Hospital Raja Permaisuri Bainun
Ipoh, Malaysia
University Malaya Medical Centre
Kuala Lumpur, Malaysia
Sarawak General Hospital
Kuching, Malaysia
Hospital Seberang Jaya
Seberang Jaya, Malaysia
National University Hospital
Singapore, Singapore
Tan Tock Seng Hospital
Singapore, Singapore

โ€ฆand 13 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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