Early treatment with targeted antibiotics for severe infections using rapid diagnostics

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to improve treatment outcomes for patients with severe infections caused by multidrug-resistant bacteria by linking rapid bacterial identification and antibiotic resistance detection to timely antibiotic prescription. Patients will be randomized into two groups: one receiving standard care and the other receiving targeted treatment with ceftazidime-avibactam based on rapid diagnostic results. The trial focuses on hospitalized patients with bloodstream infections, hospital-acquired pneumonia, or ventilator-associated pneumonia due to specific resistant bacteria. The goal is to minimize the time between infection onset and appropriate treatment, potentially leading to better clinical outcomes.

Why it matters

Who can join: the full rules

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).

Where it's running

• Christian Medical College Vellore
  Vellore, India Recruiting
• Hospital Pulau Pinang
  George Town, Malaysia Recruiting
• Hospital Raja Permaisuri Bainun
  Ipoh, Malaysia Recruiting
• University Malaya Medical Centre
  Kuala Lumpur, Malaysia Recruiting
• Sarawak General Hospital
  Kuching, Malaysia Recruiting
• Hospital Seberang Jaya
  Seberang Jaya, Malaysia Recruiting

Study contacts

• Principal investigator: David Paterson, Professor — National University of Singapore
• Study coordinator: Kithalakshmi Vignesvaran
• Email: kitha@nus.edu.sg
• Phone: 90300178

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.