Blood Stream InfectionsPhase 4RAPIDNCT05979545
EaRly impAct theraPy With Ceftazidime-avibactam Via rapID Diagnostics
A Phase 4 study testing Rapid Diagnostics in people with Blood Stream Infections and Ventilator Associated Pneumonia, run by National University of Singapore at 21 sites in 7 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blood Stream Infections, Ventilator Associated Pneumonia, Healthcare Associated Infection
- What is being tested?
- Rapid Diagnostics
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,526 participants
- Where
- 21 sitesin 7 countries
- Study dates
- 12 Dec 2023to 31 Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- For randomisation, all of the following criteria must be fulfilled:
- Written informed consent obtained from the participant or their authorised representative.
Show all 9Show fewer
- 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.
Who cannot join
- Refractory shock or comorbid condition such that the patient is not expected to survive more than 48 hours.
- Suspected catheter-related bloodstream infection where the implicated vascular catheter cannot be removed.
- Treatment is not intended to cure the infection.
- Infection requiring prolonged antibiotic treatment (more than two weeks).
- Incarceration in a correctional facility.
- Previous enrolment in the RAPID trial within the preceding 60 days.
- Patients younger than 18 years (younger than 21 years in Singapore).
Trial locations and contacts
21 sites in 7 countries. Contact the study team or a site near you to ask about taking part.
21 sites in 7 countries
Malaysia5 sites, 5 recruiting
- Recruiting
Hospital Pulau Pinang
George Town
Dato' Dr Wong Peng Shyan, drwongps@yahoo.com
Peng Shyan Wong, Dato' Dr
- Recruiting
Hospital Raja Permaisuri Bainun
Ipoh
Dato' Dr Ker Hong Bee, hbker@moh.gov.my
Hong Bee Ker, Dato' Dr
- Recruiting
University Malaya Medical Centre
Kuala Lumpur, 50603
ASSOCIATE PROF. DR. HELMI BIN SULAIMAN., helmisu@ummc.edu.my
Helmi Sulaiman, A/Prof
- Recruiting
Sarawak General Hospital
Kuching
Dr Chua Hock Hin, hhchua2004@yahoo.com
Hock Hin Chua, Dr
- Recruiting
Hospital Seberang Jaya
Seberang Jaya
Dr Ang Peng Peng, angpp2209@gmail.com
Peng Peng Ang, Dr
South Korea4 sites, 4 recruiting
- Recruiting
Korea University Ansan Hospital
Ansan
Dr Hyeri Seok, hyeri.seok@gmail.com
Hyeri Seok, Dr
- Recruiting
Soonchunhyang University Cheonan Hospital
Cheonan
Dr Oh Hyun Cho, 0809m@schmc.ac.kr
Hyun Cho Oh, Dr
- Recruiting
Kyungpook National University Chilgok Hospital
Daegu
Dr Kitae Kwon, idktkwon@gmail.com
Kitae Kwon, Dr
- Recruiting
Seoul National University Bundang Hospital
Seongnam
Prof Hong Bin Kim, hbkimmd@snu.ac.kr
Hong Bin Kim, Prof
Taiwan4 sites, 4 recruiting
- Recruiting
Kaohsiung Medical University Hospital
Kaohsiung City
Prof Po-Liang Lu, idpaul@gmail.com
Po-Liang Lu, Prof
- Recruiting
Kaohsiung Veterans General Hospital
Kaohsiung City
Dr Susan Shin-Jung Lee, ssjlee@vghks.gov.tw
Susan Shin-Jung Lee, Dr
- Recruiting
Taichung Veterans General Hospital
Taichung, Xitun District, 1650
Prof Po-Yu Liu, liupoyu@gmail.com
Po-Yu Liu, Prof
- Recruiting
National Taiwan University Hospital
Taipei
Dr Huang Yu-Shan, b101091021@gmail.com
Yu-Shan Huang, Dr
Thailand4 sites, 4 recruiting
- Recruiting
Siriraj Hospital
Bangkok
Assoc Prof Rujipas Sirijatuphat, rujipas.sir@mahidol.ac.th
Rujipas Sirijatuph, Assoc Prof
- Recruiting
Songklanagarind Hospital
Hat Yai
Dr Sarounyou Chusri, sarunyouchusri@hotmail.com
Sarounyou Chusri, Dr
- Recruiting
Srinagarind Hospital, Khon Kaen University
Khon Kaen
Asst Prof Atibordee Meesing, atibordee@kku.ac.th
Atibordee Meesing, Asst Prof
- Recruiting
Sunpasitthiprasong Hospital
Ubon Ratchathani, 34000
Dr Suwatthiya Kitsaran, suwatthiya@gmail.com
Suwatthiya Kitsaran, Dr
Singapore2 sites, 2 recruiting
- Recruiting
National University Hospital
Singapore
Dr Mo Yin, yin_mo@nuhs.edu.sg
Yin Mo, Dr
- Recruiting
Tan Tock Seng Hospital
Singapore
Dr Chan Yu Kit, yukit.chan@nhghealth.com.sg
Yu Kit Chan, Dr
India1 site, 1 recruiting
- Recruiting
Christian Medical College Vellore
Vellore
Prof George M Varghese, georgemvarghese@hotmail.com
George M Varghese, Dr
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Medipol Mega University Hospital
Istanbul
Dr Mesut Yilmaz, myilmaz@medipol.edu.tr
Mesut Yilmaz, Prof
About this study
Official title: 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)
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.
Read more
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 intervention arm will have relevant specimens analysed by rapid microbiological diagnostics and will have early availability of ceftazidime-avibactam if appropriate. Patients randomised to the control arm, will have samples analysed by clinical microbiology laboratories using standard of care diagnostics. Antibiotics will be available to these patients as per usual institutional practice.
The primary outcome is a composite of all-cause mortality or absence of improvement in Sequential Organ Failure Assessment (SOFA) score at Day 14 following the index culture.
Read the detailed description
The RAPID trial integrates rapid molecular diagnostics with locally adapted antimicrobial stewardship guidelines to facilitate timely identification of Gram-negative pathogens, detection of antimicrobial resistance genes and appropriate antibiotic selection.
In the intervention arm, positive blood cultures will undergo testing using the BioFire Blood Culture Identification 2 (BCID2) Panel, while respiratory specimens from patients with hospital-acquired pneumonia (HAP) or ventilator-associated pneumonia (VAP) will be tested using the BioFire FilmArray Pneumonia Panel or Pneumonia Plus Panel. Rapid diagnostic testing will be initiated within four hours of Gram-negative bacilli being observed on Gram stain, alongside conventional microbiological testing. Clinicians will receive guidance on interpreting resistance gene results and selecting antibiotics according to locally adapted antimicrobial stewardship protocols. Ceftazidime-avibactam will be available for patients with Pseudomonas aeruginosa or Enterobacterales with detected carbapenemase genes, subject to predefined eligibility criteria and local regulatory approval. Antibiotic treatment may subsequently be modified based on conventional susceptibility testing and clinical judgement.
In the control arm, microbiological investigations and antibiotic treatment will follow standard institutional practices, with antibiotic selection determined by the treating clinicians.
Study population assignment will be based on conventional microbiological identification and antimicrobial susceptibility testing in both arms. The main analysis population will comprise patients with bloodstream infections, HAP or VAP caused by Pseudomonas aeruginosa or carbapenem-resistant Enterobacterales. The secondary analysis population will include patients with infections caused by ceftriaxone/cefotaxime/ceftazidime-resistant Enterobacterales, carbapenem-resistant Acinetobacter baumannii-calcoaceticus complex or Stenotrophomonas maltophilia. Patients in the secondary population will receive antibiotics according to locally adapted antimicrobial stewardship guidelines rather than protocol-directed ceftazidime-avibactam.
Participants will be followed for 60 days following the index culture, with assessments of clinical outcomes, mortality, antibiotic utilisation, microbiological outcomes, antimicrobial resistance and functional status. Repeat microbiological cultures will be performed to assess bacterial persistence, and initial bacterial isolates will undergo antimicrobial susceptibility testing and whole-genome sequencing at a central laboratory.
- Conditions
- Blood Stream Infections, Ventilator Associated Pneumonia, Healthcare Associated Infection, Carbapenem-Resistant Enterobacteriaceae Infection, Hospital-acquired Pneumonia
- Being tested
- Rapid Diagnostics
- Keywords
- rapid diagnostics, ceftazidime-avibactam, carbapenemase producing Enterobacterales, hospital-acquired, MDR, AMR, ASP, CRE, BCID2, PN Plus
- Medical subject headings
- Pneumonia, Ventilator-Associated, Cross Infection, Healthcare-Associated Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rapid DiagnosticsDiagnostic test
Also called BioFire FilmArray BCID2, BioFire FilmArray Pneumonia Plus Panel, BioFire FilmArray Pneumonia Panel
Patients randomised to the intervention arm, will have the BioFire Blood Culture Identification 2 Panel (BCID2) used for positive blood cultures and/or the BioFire FilmArray Pneumonia plus PanelPneumonia Panel or Pneumonia plus Panel for respiratory tract specimens if having hospital-acquired pneumonia or ventilator-associated pneumonia.
Rapid diagnostic testing must be initiated as soon as Gram-negative bacilli is detected on Gram stain, and appropriate antibiotic must be administered according to predefined antibiotic stewardship guidelines within 24 hours of the Gram stain being performed on the index respiratory or blood culture specimen, that defined entry into the trial.
Standard of care diagnostics will also be used. Antibiotic guidelines will be provided to clinicians to aid interpretation of test results and treatment prescription. Ceftazidime-avibactam will be available for targeted use in patients with Pseudomonas aeruginosa or carbapenemase producing Enterobacterales.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | Rapid microbiological diagnostics using the BioFire BCID2 Panel for bloodstream infections or BioFire FilmArray Pneumonia/Pneumonia Plus Panel for respiratory infections, combined with locally adapted antimicrobial stewardship and early targeted antibiotic therapy.
Samples from patients randomised to the intervention arm will undergo the BioFire FilmArray systems. Patients will be then administered with the study drug, ceftazidime-avibactam when Pseudomonas aeruginosa or carbapenemase producing Enterobacterales detected.
Appropriate antibiotic must be administered according to predefined antibiotic stewardship guidelines within 24 hours of the Gram stain being performed on the index specimen. Receives: Diagnostic Test: Rapid Diagnostics |
| Control | No intervention | Standard-of-care microbiological diagnostics and antibiotic treatment according to local clinical practice and treating physician discretion. Patients randomised to the control arm, will have samples analysed by clinical microbiology laboratories using standard of care diagnostics. Antibiotics treatment will be administered as per usual institutional practice from hospital supplies. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of All-Cause Mortality or Absence of SOFA Score Improvement at Day 14
Proportion of participants experiencing all-cause mortality within 14 days of the index blood or respiratory culture, or absence of improvement in Sequential Organ Failure Assessment (SOFA) score at Day 14. SOFA improvement is defined according to the prespecified baseline SOFA criteria in the study protocol.
Measured: Day 14 following index culture.
Secondary outcomes (21)
Clinical Response at Day 7 and Day 14
Proportion of participants achieving clinical response at Day 7 and Day 14 following the index culture, assessed using clinical stability indicators, including temperature <38°C for at least 48 hours and systolic blood pressure >90 mmHg without inotropic support.
Measured: Day 7 and Day 14 following index culture
All-Cause Mortality at Day 14, Day 28 and Day 60
Proportion of participants who die from any cause within 14, 28 and 60 days following collection of the index blood or respiratory culture specimen.
Measured: Day 14, Day 28 and Day 60 following index culture
Functional Status and Health-Related Quality of Life
Functional status and health-related quality of life will be assessed using the Functional Bacteraemia and Infection Score (FBIS) and EuroQol 5-Dimension 3-Level questionnaire (EQ-5D-3L), respectively, at Day 14, Day 28 and Day 60 following the index culture.
Measured: Day 14, Day 28 and Day 60 following index culture
Desirability of Outcome Ranking (DOOR) at Day 28
Participant outcomes will be assessed using a five-level Desirability of Outcome Ranking (DOOR) composite measure incorporating survival status at Day 28, absence of early clinical response and late infectious complications. Scores range from 1 to 5, with lower scores indicating more desirable outcomes.
Measured: Day 28 following index culture
Implementation Costs and Health Economic Outcomes
Implementation costs will be evaluated using hospital and intensive care unit (ICU) length of stay within 60 days following randomisation. Within-trial and modelled economic evaluations will assess costs and health outcomes associated with rapid diagnostics and antimicrobial stewardship compared with standard care. Cost-effectiveness will be expressed using incremental cost-effectiveness ratios and net monetary benefits.
Measured: Within 60 days following randomisation for within-trial resource utilisation; modelled time horizon to be confirmed.
Days Alive and Out of Hospital Within 60 Days
Number of days participants are alive and out of hospital during the 60-day period following the index culture.
Measured: Up to Day 60 following index culture
Length of Intensive Care Unit Stay
Duration of intensive care unit (ICU) stay, measured in days, during the 60-day follow-up period.
Measured: Up to Day 60 following index culture
Length of Hospital Stay
Duration of hospitalisation, measured in days, during the 60-day follow-up period.
Measured: Up to Day 60 following index culture
Duration of Mechanical Ventilation
Total number of days participants require mechanical ventilation during the 60-day follow-up period
Measured: Up to Day 60 following index culture
Type of Accommodation Upon Hospital Discharge
Type of accommodation or care setting to which participants are discharged following hospitalisation.
Measured: At hospital discharge, assessed within 60 days following index culture
Persistence of Bacteraemia at Day 4
Proportion of participants with bloodstream infection who have persistent bacterial growth in repeat blood cultures collected on Day 4 following the index culture.
Measured: Day 4 following index culture
Microbiological Growth in Respiratory Cultures at Day 7
Proportion of participants with hospital-acquired pneumonia or ventilator-associated pneumonia who have bacterial growth detected in repeat respiratory cultures collected on Day 7 following the index culture.
Measured: Day 7 following index culture
Development of Resistance to Meropenem or Ceftazidime-Avibactam
Proportion of participants with bacterial isolates demonstrating development of resistance to meropenem or ceftazidime-avibactam during follow-up, as determined by antimicrobial susceptibility testing.
Measured: Up to Day 28 following index culture
Incidence of Acute Kidney Injury
Proportion of participants developing acute kidney injury during the 28-day follow-up period.
Measured: Up to Day 28 following index culture
Incidence of Clostridioides difficile Diarrhoea
Proportion of participants developing Clostridioides difficile-associated diarrhoea during the 28-day follow-up period.
Measured: Up to Day 28 following index culture
Time From Index Culture to Active Antibiotic Therapy
Time elapsed, measured in hours, between collection of the index culture specimen and administration of the first antibiotic with activity against the causative pathogen.
Measured: From index culture collection to initiation of active antibiotic therapy
Number of Days on Antibiotic Treatment Within 28 Days
Total number of days of antibiotic treatment administered to participants during the first 28 days following the index culture.
Measured: Up to Day 28 following index culture
Antibiotic Treatment Modification Following Microbiological Diagnosis
Proportion of participants whose antibiotic treatment is modified within seven days following availability of microbiological diagnostic results.
Measured: Within 7 days following microbiological diagnostic results
Time to Detection of Carbapenemase Production or Carbapenem Resistance
Time elapsed, measured in hours, between collection of the index specimen and reporting of carbapenemase production and/or carbapenem resistance in the causative bacterial isolate.
Measured: From index specimen collection to reporting of microbiological results
Time to Detection of Third-Generation Cephalosporin Resistance
Time elapsed, measured in hours, between collection of the index specimen and reporting of resistance to ceftriaxone, cefotaxime or ceftazidime in Enterobacterales isolates.
Measured: From index specimen collection to reporting of microbiological results
Time to Identification of Other Multidrug-Resistant Gram-Negative Pathogens
Time elapsed, measured in hours, between collection of the index specimen and identification of Acinetobacter baumannii-calcoaceticus complex or Stenotrophomonas maltophilia.
Measured: From index specimen collection to reporting of microbiological results
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2023
- Study start12 Dec 2023
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Stream InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The primary aim is to quantify the combined effect of a PCR-based rapid microbiology diagnostic system and locally adapted antibiotic stewardship on patients with infections due to Pseudomonas aeruginosa or carbapenemase producing Enterobacterales. The combined effect of diagnostics and appropriate antibiotic is the primary focus in the RAPID trial as they are closely interlinked.
- Masking
- None (open label)
- Enrolment
- 1,526 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University of Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer, Biomerieux inc
- Responsible party
- Principal investigator, Mo Yin, National University of Singapore
- Investigators
- David Paterson, Professor, Principal investigator, National University of Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05979545
- Sponsor's protocol ID
- ADVANCE-ID 22-002
- Other IDs
- 23-0135, 225457/Z/22/Z, 20535
- Acronym
- RAPID
- Status last verified
- Oct 2026
- First submitted
- 31 Jul 2023
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the results reported in the primary publication of the RAPID trial may be shared with qualified researchers following approval of a methodologically sound proposal, subject to applicable ethical, regulatory, institutional and contractual requirements.
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT05979545
- Acronym / sponsor ID
- RAPID / ADVANCE-ID 22-002
- Conditions
- Blood Stream Infections, Ventilator Associated Pneumonia, Healthcare Associated Infection, Carbapenem-Resistant Enterobacteriaceae Infection, Hospital-acquired Pneumonia
- Keywords
- rapid diagnostics, ceftazidime-avibactam, carbapenemase producing Enterobacterales, hospital-acquired, MDR, AMR, ASP, CRE
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,526 participants (estimated)
- Lead sponsor
- National University of SingaporeUniversity, hospital or other
- Collaborators
- Pfizer, Biomerieux inc
- Study start
- 12 Dec 2023 (actual)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 7 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 intervention arm will have relevant specimens analysed by rapid microbiological diagnostics and will have early availability of ceftazidime-avibactam if appropriate. Patients randomised to the control arm, will have samples analysed by clinical microbiology laboratories using standard of care diagnostics. Antibiotics will be available to these patients as per usual institutional practice.
The primary outcome is a composite of all-cause mortality or absence of improvement in Sequential Organ Failure Assessment (SOFA) score at Day 14 following the index culture.
Detailed description
The RAPID trial integrates rapid molecular diagnostics with locally adapted antimicrobial stewardship guidelines to facilitate timely identification of Gram-negative pathogens, detection of antimicrobial resistance genes and appropriate antibiotic selection.
In the intervention arm, positive blood cultures will undergo testing using the BioFire Blood Culture Identification 2 (BCID2) Panel, while respiratory specimens from patients with hospital-acquired pneumonia (HAP) or ventilator-associated pneumonia (VAP) will be tested using the BioFire FilmArray Pneumonia Panel or Pneumonia Plus Panel. Rapid diagnostic testing will be initiated within four hours of Gram-negative bacilli being observed on Gram stain, alongside conventional microbiological testing. Clinicians will receive guidance on interpreting resistance gene results and selecting antibiotics according to locally adapted antimicrobial stewardship protocols. Ceftazidime-avibactam will be available for patients with Pseudomonas aeruginosa or Enterobacterales with detected carbapenemase genes, subject to predefined eligibility criteria and local regulatory approval. Antibiotic treatment may subsequently be modified based on conventional susceptibility testing and clinical judgement.
In the control arm, microbiological investigations and antibiotic treatment will follow standard institutional practices, with antibiotic selection determined by the treating clinicians.
Study population assignment will be based on conventional microbiological identification and antimicrobial susceptibility testing in both arms. The main analysis population will comprise patients with bloodstream infections, HAP or VAP caused by Pseudomonas aeruginosa or carbapenem-resistant Enterobacterales. The secondary analysis population will include patients with infections caused by ceftriaxone/cefotaxime/ceftazidime-resistant Enterobacterales, carbapenem-resistant Acinetobacter baumannii-calcoaceticus complex or Stenotrophomonas maltophilia. Patients in the secondary population will receive antibiotics according to locally adapted antimicrobial stewardship guidelines rather than protocol-directed ceftazidime-avibactam.
Participants will be followed for 60 days following the index culture, with assessments of clinical outcomes, mortality, antibiotic utilisation, microbiological outcomes, antimicrobial resistance and functional status. Repeat microbiological cultures will be performed to assess bacterial persistence, and initial bacterial isolates will undergo antimicrobial susceptibility testing and whole-genome sequencing at a central laboratory.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The primary aim is to quantify the combined effect of a PCR-based rapid microbiology diagnostic system and locally adapted antibiotic stewardship on patients with infections due to Pseudomonas aeruginosa or carbapenemase producing Enterobacterales. The combined effect of diagnostics and appropriate antibiotic is the primary focus in the RAPID trial as they are closely interlinked.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Diagnostic Test: Rapid DiagnosticsRapid microbiological diagnostics using the BioFire BCID2 Panel for bloodstream infections or BioFire FilmArray Pneumonia/Pneumonia Plus Panel for respiratory infections, combined with locally adapted antimicrobial stewardship and early targeted antibiotic therapy. Samples from patients randomised to the intervention arm will undergo the BioFire FilmArray systems. Patients will be then administered with the study drug, ceftazidime-avibactam when Pseudomonas aeruginosa or carbapenemase producing Enterobacterales detected. Appropriate antibiotic must be administered according to predefined antibiotic stewardship guidelines within 24 hours of the Gram stain being performed on the index specimen. |
| Control | No intervention | –Standard-of-care microbiological diagnostics and antibiotic treatment according to local clinical practice and treating physician discretion. Patients randomised to the control arm, will have samples analysed by clinical microbiology laboratories using standard of care diagnostics. Antibiotics treatment will be administered as per usual institutional practice from hospital supplies. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adult patients aged 18 years or older (21 years or older in Singapore) who meet at least one of the following criteria:
- For randomisation, all of the following criteria must be fulfilled:
Key exclusion criteria (7 listed)
- Refractory shock or comorbid condition such that the patient is not expected to survive more than 48 hours.
- Suspected catheter-related bloodstream infection where the implicated vascular catheter cannot be removed.
- Treatment is not intended to cure the infection.
- Infection requiring prolonged antibiotic treatment (more than two weeks).
- Incarceration in a correctional facility.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rapid DiagnosticsAlso: BioFire FilmArray BCID2, BioFire FilmArray Pneumonia Plus Panel, BioFire FilmArray Pneumonia PanelPatients randomised to the intervention arm, will have the BioFire Blood Culture Identification 2 Panel (BCID2) used for positive blood cultures and/or the BioFire FilmArray Pneumonia plus PanelPneumonia Panel or Pneumonia plus Panel for respiratory tract specimens if having hospital-acquired pneumonia or ventilator-associated pneumonia. Rapid diagnostic testing must be initiated as soon as Gram-negative bacilli is detected on Gram stain, and appropriate antibiotic must be administered according to predefined antibiotic stewardship guidelines within 24 hours of the Gram stain being performed on the index respiratory or blood culture specimen, that defined entry into the trial. Standard of care diagnostics will also be used. Antibiotic guidelines will be provided to clinicians to aid interpretation of test results and treatment prescription. Ceftazidime-avibactam will be available for targeted use in patients with Pseudomonas aeruginosa or carbapenemase producing Enterobacterales. | Diagnostic test | Intervention |
Primary outcome
Composite of All-Cause Mortality or Absence of SOFA Score Improvement at Day 14
Time frame: Day 14 following index culture.
Proportion of participants experiencing all-cause mortality within 14 days of the index blood or respiratory culture, or absence of improvement in Sequential Organ Failure Assessment (SOFA) score at Day 14. SOFA improvement is defined according to the prespecified baseline SOFA criteria in the study protocol.
21 secondary outcomes
Clinical Response at Day 7 and Day 14
Time frame: Day 7 and Day 14 following index culture
All-Cause Mortality at Day 14, Day 28 and Day 60
Time frame: Day 14, Day 28 and Day 60 following index culture
Functional Status and Health-Related Quality of Life
Time frame: Day 14, Day 28 and Day 60 following index culture
Desirability of Outcome Ranking (DOOR) at Day 28
Time frame: Day 28 following index culture
Implementation Costs and Health Economic Outcomes
Time frame: Within 60 days following randomisation for within-trial resource utilisation; modelled time horizon to be confirmed.
Days Alive and Out of Hospital Within 60 Days
Time frame: Up to Day 60 following index culture
Length of Intensive Care Unit Stay
Time frame: Up to Day 60 following index culture
Length of Hospital Stay
Time frame: Up to Day 60 following index culture
Duration of Mechanical Ventilation
Time frame: Up to Day 60 following index culture
Type of Accommodation Upon Hospital Discharge
Time frame: At hospital discharge, assessed within 60 days following index culture
Persistence of Bacteraemia at Day 4
Time frame: Day 4 following index culture
Microbiological Growth in Respiratory Cultures at Day 7
Time frame: Day 7 following index culture
Development of Resistance to Meropenem or Ceftazidime-Avibactam
Time frame: Up to Day 28 following index culture
Incidence of Acute Kidney Injury
Time frame: Up to Day 28 following index culture
Incidence of Clostridioides difficile Diarrhoea
Time frame: Up to Day 28 following index culture
Time From Index Culture to Active Antibiotic Therapy
Time frame: From index culture collection to initiation of active antibiotic therapy
Number of Days on Antibiotic Treatment Within 28 Days
Time frame: Up to Day 28 following index culture
Antibiotic Treatment Modification Following Microbiological Diagnosis
Time frame: Within 7 days following microbiological diagnostic results
Time to Detection of Carbapenemase Production or Carbapenem Resistance
Time frame: From index specimen collection to reporting of microbiological results
Time to Detection of Third-Generation Cephalosporin Resistance
Time frame: From index specimen collection to reporting of microbiological results
Time to Identification of Other Multidrug-Resistant Gram-Negative Pathogens
Time frame: From index specimen collection to reporting of microbiological results
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the results reported in the primary publication of the RAPID trial may be shared with qualified researchers following approval of a methodologically sound proposal, subject to applicable ethical, regulatory, institutional and contractual requirements.
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Hepatitis B, Chronic
RecruitingObservational study
Evaluation of Diagnostic Accuracy and Clinical Performance of the UllCORE Bloodstream Infection (BSI) Test
Blood Stream Infection, Blood Stream Infections
RecruitingPhase 3
Comparing The Safety And Efficacy Of DEFENCATH® In Reducing Central-Line Bloodstream Infections (CLABSIs) In Adults And Adolescent Participants Receiving Total Parenteral Nutrition Through A Central Venous Catheter (CVC)
Central Line Associated Blood Stream Infections (CLABSI)
Recruiting
Prophylactic Antibiotic Treatment in Hemodialysis
Hemodialysis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David Paterson, Professor principal investigator
National University of Singapore
21 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rapid Diagnostics in people with Blood Stream Infections and Ventilator Associated Pneumonia, run by National University of Singapore at 21 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in Malaysia, South Korea, Taiwan, Thailand, Singapore and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kithalakshmi Vignesvaran (90300178, kitha@nus.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of All-Cause Mortality or Absence of SOFA Score Improvement at Day 14 (time frame: Day 14 following index culture.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.