2024-520067-13-00
Recruiting
Phase 4
EaRly impAct theraPy with ceftazidime-avibactam via rapID diagnostics versus standard of care antibiotics and diagnostics in patients with bloodstream infection, hospital-acquired pneumonia or ventilator-associated pneumonia due to Pseudomonas aeruginosa or carbapenemase producing Enterobacterales ("RAPID")
Overview
- Phase
- Phase 4
- Status
- Recruiting
- Enrollment
- 80
Overview
Brief Summary
To quantify the combined effect of rapid microbiology diagnostic system and locally adapted antibiotic stewardship on patients with infections due to Pseudomonas aeruginosa or carbapenemase producing Enterobacterales, which include bloodstream infections, hospital-acquired pneumonia and ventilator-associated pneumonia.
Study Design
- Allocation
- Randomized
- Primary Purpose
- Rapid Trial
- Masking
- None
Eligibility Criteria
- Ages
- 18 years to 65+ years (18-64 Years, 65+ Years)
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adults (above 18 years old) who are at risk of bloodstream infections, hospital-acquired pneumonia or ventilator-associated pneumonia due to Pseudomonas aeruginosa or carbapenem-resistant Enterobacterales; OR
- •Adults (above 18 years old) whose blood culture bottles show Gram negative bacilli; OR
- •Adults (above 18 years old) who are suspected to have hospital-acquired pneumonia or ventilator-associated pneumonia and whose respiratory samples show Gram negative bacteria on Gram stain
- •Consenting criteria review and Informed consent signature
Exclusion Criteria
- •Refractory shock or comorbid condition such that patient not expected to survive more than 48 hours; OR,
- •where the bloodstream infection is thought to be related to a vascular catheter and the catheter is unable to be removed; OR
- •treatment is not with the intent to cure the infection; OR,
- •patient has an infection that needs prolonged antibiotic treatment (i.e more than 2 weeks); OR,
- •patient is incarcerated in a correctional facility; OR,
- •patients previously enrolled in this trial within the last 60 days.
- •Participation in a clinical trial in which an investigational drug was administered within 30 days of screening or within the 5 half-lives of the study drug, whichever is longer. Patients for whom the proposed washout period is incompatible or inapplicable should not be enrolled in the clinical trial but should follow a standard clinical treatment plan; OR
- •Treating doctor deems enrolment into the trial is not in the best interest of the patient
- •Pregnant or breastfeeding
Investigators
ADVANCE-ID Network
Scientific
National University Of Singapore
Similar Trials
Not yet recruiting
Phase 4
Impact of Rapid Diagnostics using a FilmArray Test and Early Targeted Treatment with Ceftazidime-Avibactam for Management of Severe Infections: A Comparative Study Against Standard CareCTRI/2024/04/066197ADVANCE ID5,900
Not yet recruiting
Not Applicable
Study of incidence, resistance patterns, efficacy of ceftazidime-avibactam and aztreonam in critically ill patients with carbapenem resistant enterobacterales (CRE) infection in a tertiary care setup- A prospective observational studyCTRI/2025/07/091845BLK MAX SUPERSPECIALITY OSPITAL84
Not yet recruiting
Phase 4
Effect of Ceftazidime avibactam renal dose adjustment in first the 48hrsCTRI/2024/09/073282Glenmark Pharmaceuticals Limited108
Recruiting
Not Applicable
Microbiological Evaluation of the Effectiveness of Different Surface Decontamination Protocols for Dental ImplantsPeriimplant DiseasesDental Implant FailureDental Implant ComplicationsNCT07529444University of Zagreb90
Not yet recruiting
Not Applicable
A Comparative Study of Papacarie, V-Carie-Solve, and Conventional Methods for Caries Removal in Primary MolarsCTRI/2025/12/098862Dr. Neha Battulwar66