Bloodstream InfectionsPhase 2GAMECHANGERNCT03869437
RCT Cefiderocol vs BAT for Treatment of Gram Negative BSI
A Phase 2 study testing Cefiderocol and Best Available Therapy in people with Bloodstream Infections, run by The University of Queensland at 19 sites in 6 countries.
Trial summary
The purpose of this study is to determine whether a new antibiotic, Cefiderocol which works against a wide variety of gram negative bacteria, is equally effective as the antibiotics that are currently used as current standard of care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bloodstream Infections
- What is being tested?
- Cefiderocol and Best Available Therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 513 participants
- Where
- 19 sitesin 6 countries
- Study dates
- 28 Oct 2019to 29 Jan 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Bloodstream infection with a Gram-negative organism from at least one blood culture draw. Bacterial identification to species level will be performed using standard laboratory methods (e.g. MALDI-TOF) and susceptibility testing (e.g. Vitek2).
- The blood stream infection fulfils the criteria as a hospital acquired or healthcare associated infection as per the following definitions:
- Hospital acquired - Blood stream infection occurring greater than 48 hours after hospital admission, assessed as symptoms or signs of infection not present at time of hospital admission.
- Healthcare associated - Blood stream infection present at admission to hospital or within 48 hours of admission in patients that fulfil ANY of following criteria:
- Participant has an intravascular catheter/line that is the source of infection ii. Attended a hospital or haemodialysis clinic or received intravenous chemotherapy in the previous 30 days iii. were hospitalized in an acute care hospital for two or more days in the previous 90 days iv. resided in a nursing home or long-term care facility v. received intravenous antibiotic therapy at home, wound care or specialized nursing care through a healthcare agency, family or friends; or had self-administered intravenous antibiotic medical therapy in the 30 days before the infection
- No more than 48 hours has elapsed since the positive blood culture collection.
- Participant is aged 18 years and over (21 in Singapore)
- The participant or approved proxy is able to provide informed consent.
Who cannot join
- Refractory shock or comorbid condition such that patient not expected to survive more than 7 days.
- Participant with history of moderate to severe hypersensitivity reaction to a cephalosporin.
- Participant with significant polymicrobial bacteraemia including a significant Gram-positive pathogen (that is, a Gram-positive skin contaminant in one set of blood cultures is not regarded as significant polymicrobial bacteraemia).
- Where the bloodstream infection is thought to be related to a vascular catheter and the catheter is unable to be removed.
- Treatment is not with the intent to cure the infection (that is, palliative care is an exclusion).
- Known pregnancy or breast-feeding.
- Participant is receiving peritoneal dialysis.
- Participant previously randomised in this trial.
Trial locations and contacts
19 sites in 6 countries.
19 sites in 6 countries
Australia5 sites
Princess Alexandra Hospital
Brisbane, Queensland
Royal Brisbane and Womens Hospital
Brisbane, Queensland
The Prince Charles Hospital
Brisbane, Queensland
Austin Hospital
Melbourne, Victoria
Westmead Hospital
Sydney, New South Wales
Singapore4 sites
Changi General Hospital
Singapore
National University Hospital Singapore
Singapore
Singapore General Hospital
Singapore
Tan Tock Seng Hospital
Singapore
Taiwan4 sites
Taichung Veterans General Hospital
Taichung
National Cheng Kung University Hospital
Tainan
Tri-Service General Hospital
Taipei
Chang Gung Memorial Hospital
Taoyuan
Thailand3 sites
Ramathibodi Hospital
Bangkok
Siriraj Hospital
Bangkok
Khon Kaen University
Khon Kaen
Malaysia2 sites
University of Malaya Medical Centre
Kuala Lumpur
Universiti Sains Malaysia
Kubang Kerian, Kelantan
About this study
Official title: Investigator Driven Randomized Controlled Trial of Cefiderocol Versus Standard Therapy for Healthcare Associated and Hospital Acquired Gram-negative Blood Stream Infection: Study Protocol (the GAME CHANGER Trial)
The purpose of this study is to determine whether a new antibiotic, Cefiderocol which works against a wide variety of gram negative bacteria, is equally effective as the antibiotics that are currently used as current standard of care.
Read the detailed description
Infections with antibiotic resistant bacteria cause a significant burden of disease worldwide. Bloodstream infections may arise from a variety of sources, are commonly encountered in clinical practice, and are associated with significant morbidity and mortality. Antibiotics that have activity against a broad spectrum of pathogens are commonly suggested in treatment guidelines to adequately cover bloodstream infections. Increasing rates of resistance to antibiotics commonly used for bloodstream infection are problematic and may lead to initial empiric therapy not having activity against the pathogen isolated. In patients with bloodstream infections and sepsis, delay until the receipt of effective therapy is associated with an increase in mortality.
Increasing rates of antibiotic resistance in Gram-negative organisms due to the presence of extended spectrum beta lactamases (ESBL), hyperproduction of AmpC enzymes, carbapenemases and other mechanisms of resistance are identified in common hospital and healthcare associated pathogens including Enterobacteriaceae, Pseudomonas aeruginosa and Acinetobacter baumannii. Uncommonly, Gram-negative organisms such as Klebsiella pneumoniae and, in tropical areas such as south-east Asia and northern Australia, Burkholderia pseudomallei can cause severe community-acquired pneumonia resulting in bloodstream infection.
Cefiderocol (previously S-649266) is a novel siderophore cephalosporin antibiotic with a catechol moiety on the 3-position side chain. The catechol side chain enables ferric iron ion binding, and the resulting complex of cefiderocol and iron ions is actively transported into bacteria via ferric iron transporter systems with subsequent destruction of cell wall synthesis. Cefiderocol has been shown to be potent in vitro against a broad range of Gram-negative organisms, including carbapenem-resistant Enterobacteriaceae (CRE) and multi-drug resistant (MDR) P. aeruginosa and A. baumannii . This activity is considered to be due to not only efficient uptake via the active siderophore systems but also the high stability of cefiderocol against carbapenemase hydrolysis. Limited in vitro data suggests cefiderocol may have activity against B. pseudomallei.
Recent clinical data has shown cefiderocol to be effective in the setting of complicated urinary tract infections , including patients with concomitant bacteremia. A study examining the use of cefiderocol in the setting of infections caused by carbapenem-resistant organisms is currently underway, as is a study of cefiderocol for hospital acquired pneumonia (ClinicalTrials.gov NCT02714595 \& NCT03032380). Given the broad spectrum of activity against Gram-negative organisms, including those with resistant phenotypes, cefiderocol may be an ideal agent for empiric use in the setting of bloodstream infections acquired in the hospital or healthcare setting but as yet no clinical trial has examined this.
- Conditions
- Bloodstream Infections
- Being tested
- Cefiderocol, Best Available Therapy
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CefiderocolDrug
Also called S-649266
2 grams intravenously administered over 3 hours every 8 hours for a period of 5 to 14 days (dosage adjustment is necessary based on renal function).
Best Available TherapyOther
Standard of care was determined by the investigator
| Study group | Role | What they receive |
|---|---|---|
| Cefiderocol | Experimental | Participants will receive Cefiderocol 2 grams administered intravenously over 3 hours, every 8 hours for a minium of 5 days and a maximun of 14 days. Receives: Drug: Cefiderocol |
| Best Available Therapy (BAT) | Active comparator | BAT will be chosen by the investigator and intravenously administered per country-specific guidelines. Receives: Other: Best Available Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality at 14 days
To compare the 14-day mortality from day of randomisation of each regimen (cefiderocol versus standard of care therapy). If the primary objective meets the criteria for non-inferiority (with a margin of 10% for the difference in proportions), superiority will be examined.
Measured: 14 days post date of randomisation
Secondary outcomes (8)
Mortality post blood stream infection of each regimen at longer time points
If a date of death is recorded on or before our calculation of Day 14, the participant will be classed as dead, otherwise considered to be alive. Similar for Day 30. Where possible this rule will also be applied for Day 90 vital status. If the Day 90 follow-up actually occurred on day 85 to 89 and the participant was alive we will assume the participant was alive at day 90.
Measured: 30 and 90 days, from day of randomisation or "day 1"
Clinical and microbiological failure at day 14
Defined as composite of:
- Death
- Still in hospital and clinical failure, as defined by
- If baseline SOFA ≥3, D(day)14 SOFA not improved by ≥30%
- If baseline SOFA <3, D14 SOFA worse
- Microbiological failure (GNB Growth in blood of same species as index GNB from days 3-14)
The SOFA score we will calculate is a slight modification of the original SOFA score. It will be used for ICU and non-ICU participants. The sole modification is that the respiratory component will be scored as in the modified SOFA:
- 0 (if SaO2/FiO2 >400)
- 1 (if SaO2/FiO2 315-400)
- 2 (if SaO2/FiO2 235-314)
- 3 (if SaO2/FiO2 150-234)
- 4 (if SaO2/FiO2 <150)
Measured: Day 14, from day of randomisation or "day 1"
Microbiological failure days 3 to 90 post randomisation
Defined as growth in blood cultures of the same GNB as the index blood culture(s), from day 3 up to day 90.
Measured: Day 3 through to day 90
Colonisation or infection with methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant enterococci (VRE), carbapenem-resistant Gram-negative bacilli or Candida bloodstream infection.
Defined as the presence of MRSA, VRE or carbapenem-resistant Gram-negative bacilli (of a different species from primary BSI organism) on culture +/- molecular test of clinical samples or screening swabs, or Candida species grown in blood cultures from day 3 up to day 90.
Measured: Day 3 through to day 90
Clostridioides difficile infection days 3 to 90 post randomisation.
Defined as presence of a compatible clinical illness with a positive laboratory stool test for C. difficile (as per local diagnostic protocol / method).
Measured: Day 3 through to day 90
Improvement in functional status at day 30 post randomisation compared to baseline.
Functional status will be measured according to a score ranging from 0 (dead) to 7 (out of hospital, healthy, able to complete daily actvities). This score is based on the Functional Bloodstream Infection Score (FBIS) [McNamara et al. Clin Microbiol Infect. 2020 Feb;26(2):257.e1-257].
Measured: Day 30, from day of randomisation or "day 1"
Time to hospital discharge.
Defined as to the day of first discharge alive (e.g. Day 2 is the day after randomisation). However, if a participant dies in the 3 days following first hospital discharge, we will consider that participant as not having a discharge alive.
Measured: From day of randomisation or "day 1" through to day 90
Treatment emergent SAEs (Serious Adverse Events)
Defined as a serious adverse event possibly, probably or definitely related to the randomised drug treatment.
Measured: From day of randomisation or "day 1" through to 5 days post end of study treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2019
- Study start28 Oct 2019
- Primary completion13 Nov 2023
- Study completion29 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Bloodstream 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 513 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Queensland
- Sponsor type
- University, hospital or other
- Collaborators
- Shionogi
- Responsible party
- Sponsor
- Investigators
- David Paterson, Professor, Principal investigator, The Univeristy of Queensland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03869437
- Sponsor's protocol ID
- GAME CHANGER
- Acronym
- GAMECHANGER
- Status last verified
- Jan 2024
- First submitted
- 6 Feb 2019
- Last updated
- 13 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Paterson DL, Sulaiman H, Liu PY, Chatfield MD, Yilmaz M, Salmuna ZN, Mazlan MZ, Anunnatsiri S, Sirijatuphat R, Chotiprasitsakul D, Lye DC, Somani J, Kalimuddin S, Aslan AT, Thamlikitkul V, Lee YT, Yang YS, Lin YT, Ramli WNW, Tseng CH, Archuleta S, Chan YFZ, Forde BM, Wright H, Stewart AG, Ramsay KA, Ling W, Rossi V, Harris-Brown TM, Harris PNA; GAME CHANGER Trial Investigators. Cefiderocol versus standard therapy for hospital-acquired and health-care-associated Gram-negative bacterial bloodstream infection (the GAME CHANGER trial): an open-label, parallel-group, randomised trial. Lancet Infect Dis. 2026 Feb;26(2):148-159. doi: 10.1016/S1473-3099(25)00469-4. Epub 2025 Oct 6.
PubMed 41067237Wright H, Harris PNA, Chatfield MD, Lye D, Henderson A, Harris-Brown T, Donaldson A, Paterson DL. Investigator-Driven Randomised Controlled Trial of Cefiderocol versus Standard Therapy for Healthcare-Associated and Hospital-Acquired Gram-negative Bloodstream Infection: Study protocol (the GAME CHANGER trial): study protocol for an open-label, randomised controlled trial. Trials. 2021 Dec 7;22(1):889. doi: 10.1186/s13063-021-05870-w.
PubMed 34876196
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigator Driven Randomized Controlled Trial of Cefiderocol Versus Standard Therapy for Healthcare Associated and Hospital Acquired Gram-negative Blood Stream Infection: Study Protocol (the GAME CHANGER Trial)
- ClinicalTrials.gov ID
- NCT03869437
- Acronym / sponsor ID
- GAMECHANGER / GAME CHANGER
- Conditions
- Bloodstream Infections
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 513 participants (actual)
- Lead sponsor
- The University of QueenslandUniversity, hospital or other
- Collaborators
- Shionogi
- Study start
- 28 Oct 2019 (actual)
- Primary completion
- 13 Nov 2023 (actual)
- Study completion
- 29 Jan 2024 (actual)
- First posted
- 11 Mar 2019 (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.
The purpose of this study is to determine whether a new antibiotic, Cefiderocol which works against a wide variety of gram negative bacteria, is equally effective as the antibiotics that are currently used as current standard of care.
Detailed description
Infections with antibiotic resistant bacteria cause a significant burden of disease worldwide. Bloodstream infections may arise from a variety of sources, are commonly encountered in clinical practice, and are associated with significant morbidity and mortality. Antibiotics that have activity against a broad spectrum of pathogens are commonly suggested in treatment guidelines to adequately cover bloodstream infections. Increasing rates of resistance to antibiotics commonly used for bloodstream infection are problematic and may lead to initial empiric therapy not having activity against the pathogen isolated. In patients with bloodstream infections and sepsis, delay until the receipt of effective therapy is associated with an increase in mortality.
Increasing rates of antibiotic resistance in Gram-negative organisms due to the presence of extended spectrum beta lactamases (ESBL), hyperproduction of AmpC enzymes, carbapenemases and other mechanisms of resistance are identified in common hospital and healthcare associated pathogens including Enterobacteriaceae, Pseudomonas aeruginosa and Acinetobacter baumannii. Uncommonly, Gram-negative organisms such as Klebsiella pneumoniae and, in tropical areas such as south-east Asia and northern Australia, Burkholderia pseudomallei can cause severe community-acquired pneumonia resulting in bloodstream infection.
Cefiderocol (previously S-649266) is a novel siderophore cephalosporin antibiotic with a catechol moiety on the 3-position side chain. The catechol side chain enables ferric iron ion binding, and the resulting complex of cefiderocol and iron ions is actively transported into bacteria via ferric iron transporter systems with subsequent destruction of cell wall synthesis. Cefiderocol has been shown to be potent in vitro against a broad range of Gram-negative organisms, including carbapenem-resistant Enterobacteriaceae (CRE) and multi-drug resistant (MDR) P. aeruginosa and A. baumannii . This activity is considered to be due to not only efficient uptake via the active siderophore systems but also the high stability of cefiderocol against carbapenemase hydrolysis. Limited in vitro data suggests cefiderocol may have activity against B. pseudomallei.
Recent clinical data has shown cefiderocol to be effective in the setting of complicated urinary tract infections , including patients with concomitant bacteremia. A study examining the use of cefiderocol in the setting of infections caused by carbapenem-resistant organisms is currently underway, as is a study of cefiderocol for hospital acquired pneumonia (ClinicalTrials.gov NCT02714595 \& NCT03032380). Given the broad spectrum of activity against Gram-negative organisms, including those with resistant phenotypes, cefiderocol may be an ideal agent for empiric use in the setting of bloodstream infections acquired in the hospital or healthcare setting but as yet no clinical trial has examined this.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cefiderocol | Experimental | Drug: CefiderocolParticipants will receive Cefiderocol 2 grams administered intravenously over 3 hours, every 8 hours for a minium of 5 days and a maximun of 14 days. |
| Best Available Therapy (BAT) | Active comparator | Other: Best Available TherapyBAT will be chosen by the investigator and intravenously administered per country-specific guidelines. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Bloodstream infection with a Gram-negative organism from at least one blood culture draw. Bacterial identification to species level will be performed using standard laboratory methods (e.g. MALDI-TOF) and susceptibility testing (e.g. Vitek2).
- The blood stream infection fulfils the criteria as a hospital acquired or healthcare associated infection as per the following definitions:
- No more than 48 hours has elapsed since the positive blood culture collection.
- Participant is aged 18 years and over (21 in Singapore)
- The participant or approved proxy is able to provide informed consent.
Key exclusion criteria (8 listed)
- Refractory shock or comorbid condition such that patient not expected to survive more than 7 days.
- Participant with history of moderate to severe hypersensitivity reaction to a cephalosporin.
- Participant with significant polymicrobial bacteraemia including a significant Gram-positive pathogen (that is, a Gram-positive skin contaminant in one set of blood cultures is not regarded as significant polymicrobial bacteraemia).
- Where the bloodstream infection is thought to be related to a vascular catheter and the catheter is unable to be removed.
- Treatment is not with the intent to cure the infection (that is, palliative care is an exclusion).
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 |
|---|---|---|
| CefiderocolAlso: S-6492662 grams intravenously administered over 3 hours every 8 hours for a period of 5 to 14 days (dosage adjustment is necessary based on renal function). | Drug | Cefiderocol |
| Best Available TherapyStandard of care was determined by the investigator | Other | Best Available Therapy (BAT) |
Primary outcome
Mortality at 14 days
Time frame: 14 days post date of randomisation
To compare the 14-day mortality from day of randomisation of each regimen (cefiderocol versus standard of care therapy). If the primary objective meets the criteria for non-inferiority (with a margin of 10% for the difference in proportions), superiority will be examined.
8 secondary outcomes
Mortality post blood stream infection of each regimen at longer time points
Time frame: 30 and 90 days, from day of randomisation or "day 1"
Clinical and microbiological failure at day 14
Time frame: Day 14, from day of randomisation or "day 1"
Microbiological failure days 3 to 90 post randomisation
Time frame: Day 3 through to day 90
Colonisation or infection with methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant enterococci (VRE), carbapenem-resistant Gram-negative bacilli or Candida bloodstream infection.
Time frame: Day 3 through to day 90
Clostridioides difficile infection days 3 to 90 post randomisation.
Time frame: Day 3 through to day 90
Improvement in functional status at day 30 post randomisation compared to baseline.
Time frame: Day 30, from day of randomisation or "day 1"
Time to hospital discharge.
Time frame: From day of randomisation or "day 1" through to day 90
Treatment emergent SAEs (Serious Adverse Events)
Time frame: From day of randomisation or "day 1" through to 5 days post end of study treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2024.
- Derived from this study: PubMed 41067237Paterson DL, Sulaiman H, Liu PY, Chatfield MD, Yilmaz M, Salmuna ZN, Mazlan MZ, Anunnatsiri S, Sirijatuphat R, Chotiprasitsakul D, Lye DC, Somani J, Kalimuddin S, Aslan AT, Thamlikitkul V, Lee YT, Yang YS, Lin YT, Ramli WNW, Tseng CH, Archuleta S, Chan YFZ, Forde BM, Wright H, Stewart AG, Ramsay KA, Ling W, Rossi V, Harris-Brown TM, Harris PNA; GAME CHANGER Trial Investigators. Cefiderocol versus standard therapy for hospital-acquired and health-care-associated Gram-negative bacterial bloodstream infection (the GAME CHANGER trial): an open-label, parallel-group, randomised trial. Lancet Infect Dis. 2026 Feb;26(2):148-159. doi: 10.1016/S1473-3099(25)00469-4. Epub 2025 Oct 6.
- Derived from this study: PubMed 34876196Wright H, Harris PNA, Chatfield MD, Lye D, Henderson A, Harris-Brown T, Donaldson A, Paterson DL. Investigator-Driven Randomised Controlled Trial of Cefiderocol versus Standard Therapy for Healthcare-Associated and Hospital-Acquired Gram-negative Bloodstream Infection: Study protocol (the GAME CHANGER trial): study protocol for an open-label, randomised controlled trial. Trials. 2021 Dec 7;22(1):889. doi: 10.1186/s13063-021-05870-w.
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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. This study is not recruiting at the moment.
David Paterson, Professor principal investigator
The Univeristy of Queensland
19 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cefiderocol and Best Available Therapy in people with Bloodstream Infections, run by The University of Queensland at 19 sites in 6 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 8 inclusion and 8 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: finished, as of the sponsor's last update on 13 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Australia, Singapore, Taiwan, Thailand, Malaysia and 1 more country. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality at 14 days (time frame: 14 days post date of randomisation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03869437, which also lists 2 linked publications.
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 13 Feb 2024.