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Search / Trial NCT05979545

EaRly impAct theraPy With Ceftazidime-avibactam Via rapID Diagnostics

Launched by NATIONAL UNIVERSITY OF SINGAPORE · Jul 31, 2023

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Rapid Diagnostics Ceftazidime Avibactam Carbapenemase Producing Enterobacterales Hospital Acquired Mdr Amr Asp Cre Bcid2 Pn Plus

ClinConnect Summary

This clinical trial, called EaRly impAct theraPy, is studying a new approach to treat serious infections caused by certain bacteria, particularly those that are resistant to standard antibiotics. The main goal is to speed up the process of identifying the bacteria causing an infection and determining the best antibiotic treatment, specifically using a drug called ceftazidime-avibactam. This trial will compare two groups of patients: one group will receive the new rapid testing and treatment approach, while the other group will receive the usual testing and treatment methods. Researchers hope that by acting faster, patients will have better outcomes when dealing with infections like hospital-acquired pneumonia or bloodstream infections.

To be eligible for this trial, patients must show symptoms of a serious infection and have a relevant sample, like a blood culture, sent to the lab. However, those with certain serious conditions or infections related to a vascular catheter may not be included. Participants in the trial can expect to be randomly assigned to either the new treatment method or the standard care, and they will be closely monitored throughout the study. This trial is currently recruiting patients and aims to improve how quickly and effectively patients receive the right antibiotic treatment for their infections.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. patient developed clinical symptoms compatible with bloodstream infection, hospital-acquired or ventilator-associated pneumonia (hospital-acquired and ventilator-associated pneumonia should fulfil US CDC NHSN criteria) AND,
  • 2. an appropriate specimen has been received by the participating laboratory - that is, a blood culture bottle showing Gram negative bacilli or a respiratory sample collected for clinical purposes showing Gram negative bacilli on Gram stain;
  • Exclusion Criteria:
  • 1. Refractory shock or comorbid condition such that patient not expected to survive more than 48 hours; OR,
  • 2. where the bloodstream infection is thought to be related to a vascular catheter and the catheter is unable to be removed; OR,
  • 3. treatment is not with the intent to cure the infection; OR,
  • 4. patient is incarcerated in a correctional facility; OR,
  • 5. patients previously randomised in this trial within the last 60 days.

About National University Of Singapore

The National University of Singapore (NUS) is a leading global research university recognized for its commitment to advancing scientific knowledge and fostering innovation in healthcare. With a strong emphasis on interdisciplinary collaboration, NUS conducts cutting-edge clinical trials aimed at addressing critical health challenges and improving patient outcomes. The university's state-of-the-art facilities, coupled with its team of renowned researchers and clinicians, enable the development and evaluation of novel therapies and interventions. NUS is dedicated to translating research findings into practical applications, ultimately enhancing the quality of care and contributing to the advancement of medical science.

Locations

Kaohsiung, , Taiwan

Kuala Lumpur, , Malaysia

Ubon Ratchathani, , Thailand

Taichung, Xitun District, Taiwan

Patients applied

0 patients applied

Trial Officials

David Paterson, Professor

Principal Investigator

National University of Singapore

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported