Bloodstream InfectionsPhase 4MERINONCT02176122
RCT Meropenem vs Piperacillin-Tazobactam for Definitive Treatment of BSI's Due to Ceftriaxone Non-susceptible Escherichia Coli and Klebsiella Spp.
A Phase 4 study testing Meropenem and Piperacillin-tazobactam combination product in people with Bloodstream Infections, run by The University of Queensland at 31 sites in 9 countries.
Trial summary
No randomized controlled trials (RCTs) have yet been performed comparing different treatment options for AmpC or ESBL-producing Enterobacteriaceae. During the last 10 years we have seen an exponentially increasing rate of carbapenem resistance worldwide, including Australia and New Zealand. 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?
- Meropenem and Piperacillin-tazobactam combination product
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 391 participants
- Where
- 31 sitesin 9 countries
- Study dates
- Feb 2014to 7 Aug 2017
- Phase
- Phase 4
- 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 E. coli or Klebsiella spp. with proven non-susceptibility to third generation cephalosporins and susceptibility to meropenem and piperacillin-tazobactam from at least one blood culture draw. This will be determined in accordance with laboratory methods and susceptibility breakpoints defined by EUCAST standards (www. eucast.org). Bacterial identification to species level will be performed using standard laboratory methods (e.g. MALDI-TOF) and susceptibility testing (e.g. Vitek2)
- No more than 72 hours has elapsed since the first positive blood culture collection.
- Patient is aged 18 years and over
- The patient or approved proxy is able to provide informed consent.
Who cannot join
- Patient not expected to survive more than 4 days
- Patient allergic to a penicillin or a carbapenem
- Patient with significant polymicrobial bacteraemia (that is, a Gram positive skin contaminant in one set of blood cultures is not regarded as significant polymicrobial bacteraemia).
- Treatment is not with the intent to cure the infection (that is, palliative care is an exclusion).
- Pregnancy or breast-feeding.
- Use of concomitant antimicrobials in the first 4 days after enrolment with known activity against Gram-negative bacilli (except trimethoprim/sulfamethoxazole may be continued as Pneumocystis prophylaxis).
Trial locations and contacts
31 sites in 9 countries.
31 sites in 9 countries
Australia14 sites
Brisbane Private Hospital
Brisbane, Queensland, 4000
St. Andrew's War Memorial Hospital
Brisbane, Queensland, 4001
Mater Misericordiae Health Services Brisbane Ltd.
Brisbane, Queensland
Monash Health
Clayton, Victoria, 3168
Peter MacCallum Cancer Centre
East Melbourne, Victoria, 3002
Barwon Health
Geelong, Victoria, 3220
Royal Brisbane and Women's Hospital
Herston, Queensland, 4029
The Alfred Hospital
Melbourne, Victoria, 3004
Royal Perth Hospital
Perth, Western Australia, 6000
Fiona Stanley Hospital
Perth
Shellharbour Hospital (Illawarra Shoalhaven Local Health District)
Shellharbour, New South Wales
Westmead Hospital
Westmead, New South Wales, 2145
Wollongong Hospital
Wollongong, New South Wales, 2500
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102
Italy6 sites
Teaching Hospital - Sant'Orsola Malpighi
Bologna
Dipartimento di Scienze Biomediche e Cliniche "L. Sacco". Azienda Ospedaliera - Polo Universitario
Milan
"Sapienza" University of Rome
Rome
Catholic University Rome
Rome
Sanremo Hospital
Sanremo
Santa Maria Misericorida University Hospital
Udine
New Zealand2 sites
Middlemore Hospital
Papatoetoe, 2025
The North Shore Hospital
Westlake, 0622
Saudi Arabia2 sites
King Fahad Specialist Hospital
Dammam
King Saud Bin Abdulaziz University for Health Sciences, King Abdulaziz Medical City
Riyadh
Singapore2 sites
National University Hospital
Singapore, 119074
Tan Tock Seng Hospital
Singapore, 308433
South Africa2 sites
Groote Schuur Hospital
Cape Town
Charlotte Maxeke Johannesberg Academic Hospital
Johannesburg
Turkey (Türkiye)1 site
İstanbul Medipol Üniversitesi Medipol Mega Hastaneler Kompleksi (Medipol Mega Hospitals Complex)
Istanbul
About this study
Official title: Randomized Controlled Trial of Meropenem Versus Piperacillin-Tazobactam for Definitive Treatment of Bloodstream Infections Due to Ceftriaxone Non-susceptible E. Coli and Klebsiella Species.
No randomized controlled trials (RCTs) have yet been performed comparing different treatment options for AmpC or ESBL-producing Enterobacteriaceae. During the last 10 years we have seen an exponentially increasing rate of carbapenem resistance worldwide, including Australia and New Zealand. The investigators urgently need data from well-designed RCTs to guide clinicians in the treatment of antibiotic resistant Gram-negative infections. The investigators face a situation where a commonly used antibiotic for these infections (meropenem) may be driving carbapenem resistance. For this reason, the investigators are seeking to compare a carbapenem-sparing regimen with a carbapenem for the treatment of these infections. Formal evaluation of safety and efficacy of generic antibiotics in the treatment of infection is of immense clinical and public health importance, and no formal trial has yet been conducted to address these issues. The international collaboration between teams of clinician researchers, some of whom are leaders in their field, makes it highly likely that the outcomes of this trial will have a significant impact on clinical practice.
The investigators' hypothesis is that piperacillin/tazobactam (a carbapenem-sparing regimen) is non-inferior to meropenem (a widely used carbapenem) for the definitive treatment of bloodstream infections due to third-generation cephalosporin non-susceptible E. coli or Klebsiella species.
Read the detailed description
Escherichia coli and Klebsiella spp. are common causes of bacteraemia, and may acquire genes encoding extended-spectrum beta-lactamases (ESBLs) or AmpC beta-lactamases (1). ESBL or AmpC producers are typically resistant to third generation cephalosporins such as ceftriaxone, but susceptible to carbapenems (1). Observational studies have been performed evaluating antibiotic choices for ESBL producers (2-9). In no study has the outcome of treatment for serious infections for ESBL producers been significantly surpassed by carbapenems (2-9).
Despite the potential advantages of carbapenems for treatment of ceftriaxone non-susceptible organisms, widespread use of carbapenems may cause selection pressure leading to carbapenem-resistant organisms. This is a significant issue since carbapenem-resistant organisms are treated with "last-line" antibiotics such as colistin. Some new beta-lactam antibiotics and beta-lactamase inhibitors, which are active against ESBL, AmpC and some carbapenemase producing organisms, are in advanced clinical development (10). However, these antibiotics are likely to be expensive and may best be held in reserve for infections where there are no alternatives. Therefore, we see a need for establishing the efficacy of a generically available alternative to carbapenems for serious infections.
The susceptibility of ESBL producers and AmpC producers to piperacillin/tazobactam is less predictable than that of carbapenems. By definition, ESBLs are inhibited by beta-lactamase inhibitors such as tazobactam (1). However, E. coli or Klebsiella may produce multiple beta-lactamase types some of which are resistant to inhibition by tazobactam. Additionally, in some cases outer membrane protein loss may contribute to resistance to tazobactam. By definition, AmpC is not inhibited by beta-lactamase inhibitors such as tazobactam. However, despite these limitations, approximately 50% or more of ceftriaxone non-susceptible E. coli or Klebsiellae remain susceptible in vitro to piperacillin/tazobactam (1).
No randomised controlled trials have yet been performed comparing different treatment options for ceftriaxone resistant Enterobacteriaceae. The largest observational study with an analysis by treatment outcome was published in February 2012 by Rodriguez-Bano and colleagues (9). They performed a post-hoc analysis of six published cohorts of patients with bacteraemia due to ESBL producing E. coli. Two nonmutually exclusive cohorts (empirical therapy and definitive therapy) were constructed and analysed separately. In both cohorts, carbapenems were not superior to beta-lactam/beta-lactamase inhibitor combinations (BLBLIC). Specifically, in the definitive therapy cohort, mortality rates at 30 days were not significantly different - 9.3% for those who received a BLBLIC and 16.7% for those who received a carbapenem (p>0.20) (9).
- Conditions
- Bloodstream Infections
- Being tested
- Meropenem, Piperacillin-tazobactam combination product
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MeropenemDrug
Also called Merrem, Meronem
Meropenem is a carbapenem anti-bacterial used for the treatment of serious infections in patients.
Piperacillin-tazobactam combination productDrug
Also called Zosyn, Tazocin
Piperacillin-tazobactam is used for the treatment of patients with systemic and/or local bacterial infections.
| Study group | Role | What they receive |
|---|---|---|
| Meropenem | Active comparator | Meropenem 1g adm every 8 hours IV up to study day 4. Receives: Drug: Meropenem |
| Piperacillin-tazobactam combination product | Experimental | Piperacillin/tazobactam 4.5g adm every 6 hours IV up to study day 4. Receives: Drug: Piperacillin-tazobactam combination product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality at 30 days
To compare the 30-day mortality post bloodstream infection of piperacillin/tazobactam and meropenem.
Measured: 30 days
Secondary outcomes (5)
Time to clinical and microbiologic resolution of infection
defined as number of days from randomisation to resolution of fever (temperature > 38.0o C) and leucocytosis (white blood cell count >12x109/L) PLUS sterilisation of blood cultures.
Measured: on or before study day 4
Clinical and microbiologic success
defined as survival PLUS resolution of fever and leucocytosis PLUS sterilisation of blood cultures
Measured: day 4
Microbiologic resolution of infection
defined as sterility of blood cultures collected on or before day 4
Measured: day 4
Microbiologic relapse
defined as growth of a meropenem resistant Gram negative bacillus from any clinical specimen collected or a positive stool test (according to local lab diagnostic procedures) for C. difficile, from day 4 of study drug administration to day 30
Measured: day 30
Superinfection with a carbapenem or piperacillin-tazobactam resistant organism or Clostridium Difficile
To compare the risk of superinfection with a carbapenem resistant organism with each regimen.
Measured: day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2014 (estimated)
- Study startFeb 2014
- Primary completion7 Jul 2017
- Study completion7 Aug 2017
Why it stopped: Secondary to third interim analysis by the study DSMB.
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 391 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Queensland
- Sponsor type
- University, hospital or other
- Collaborators
- International Society of Chemotherapy, Australian Society for Antimicrobials, Queensland Clinical Trials & Biostatistics Centre, Australasian Society for Infectious Diseases
- Responsible party
- Principal investigator, Professor David L. Paterson, The University of Queensland
- Investigators
- David L Paterson, MD, PhD, Principal investigator, UQCCR, RBWH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02176122
- Sponsor's protocol ID
- ACTRN12613000532707
- Acronym
- MERINO
- Status last verified
- Nov 2017
- First submitted
- 24 Jun 2014
- Last updated
- 27 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Harris PNA, Tambyah PA, Lye DC, Mo Y, Lee TH, Yilmaz M, Alenazi TH, Arabi Y, Falcone M, Bassetti M, Righi E, Rogers BA, Kanj S, Bhally H, Iredell J, Mendelson M, Boyles TH, Looke D, Miyakis S, Walls G, Al Khamis M, Zikri A, Crowe A, Ingram P, Daneman N, Griffin P, Athan E, Lorenc P, Baker P, Roberts L, Beatson SA, Peleg AY, Harris-Brown T, Paterson DL; MERINO Trial Investigators and the Australasian Society for Infectious Disease Clinical Research Network (ASID-CRN). Effect of Piperacillin-Tazobactam vs Meropenem on 30-Day Mortality for Patients With E coli or Klebsiella pneumoniae Bloodstream Infection and Ceftriaxone Resistance: A Randomized Clinical Trial. JAMA. 2018 Sep 11;320(10):984-994. doi: 10.1001/jama.2018.12163.
PubMed 30208454Harris PN, Peleg AY, Iredell J, Ingram PR, Miyakis S, Stewardson AJ, Rogers BA, McBryde ES, Roberts JA, Lipman J, Athan E, Paul SK, Baker P, Harris-Brown T, Paterson DL. Meropenem versus piperacillin-tazobactam for definitive treatment of bloodstream infections due to ceftriaxone non-susceptible Escherichia coli and Klebsiella spp (the MERINO trial): study protocol for a randomised controlled trial. Trials. 2015 Jan 27;16:24. doi: 10.1186/s13063-014-0541-9.
PubMed 25623485
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Meropenem Versus Piperacillin-Tazobactam for Definitive Treatment of Bloodstream Infections Due to Ceftriaxone Non-susceptible E. Coli and Klebsiella Species.
- ClinicalTrials.gov ID
- NCT02176122
- Acronym / sponsor ID
- MERINO / ACTRN12613000532707
- Conditions
- Bloodstream Infections
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Secondary to third interim analysis by the study DSMB.
- Enrolment
- 391 participants (actual)
- Lead sponsor
- The University of QueenslandUniversity, hospital or other
- Collaborators
- International Society of Chemotherapy, Australian Society for Antimicrobials, Queensland Clinical Trials & Biostatistics Centre, Australasian Society for Infectious Diseases
- Study start
- Feb 2014
- Primary completion
- 7 Jul 2017 (actual)
- Study completion
- 7 Aug 2017 (actual)
- First posted
- 26 Jun 2014 (estimated)
- 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.
No randomized controlled trials (RCTs) have yet been performed comparing different treatment options for AmpC or ESBL-producing Enterobacteriaceae. During the last 10 years we have seen an exponentially increasing rate of carbapenem resistance worldwide, including Australia and New Zealand. The investigators urgently need data from well-designed RCTs to guide clinicians in the treatment of antibiotic resistant Gram-negative infections. The investigators face a situation where a commonly used antibiotic for these infections (meropenem) may be driving carbapenem resistance. For this reason, the investigators are seeking to compare a carbapenem-sparing regimen with a carbapenem for the treatment of these infections. Formal evaluation of safety and efficacy of generic antibiotics in the treatment of infection is of immense clinical and public health importance, and no formal trial has yet been conducted to address these issues. The international collaboration between teams of clinician researchers, some of whom are leaders in their field, makes it highly likely that the outcomes of this trial will have a significant impact on clinical practice.
The investigators' hypothesis is that piperacillin/tazobactam (a carbapenem-sparing regimen) is non-inferior to meropenem (a widely used carbapenem) for the definitive treatment of bloodstream infections due to third-generation cephalosporin non-susceptible E. coli or Klebsiella species.
Detailed description
Escherichia coli and Klebsiella spp. are common causes of bacteraemia, and may acquire genes encoding extended-spectrum beta-lactamases (ESBLs) or AmpC beta-lactamases (1). ESBL or AmpC producers are typically resistant to third generation cephalosporins such as ceftriaxone, but susceptible to carbapenems (1). Observational studies have been performed evaluating antibiotic choices for ESBL producers (2-9). In no study has the outcome of treatment for serious infections for ESBL producers been significantly surpassed by carbapenems (2-9).
Despite the potential advantages of carbapenems for treatment of ceftriaxone non-susceptible organisms, widespread use of carbapenems may cause selection pressure leading to carbapenem-resistant organisms. This is a significant issue since carbapenem-resistant organisms are treated with "last-line" antibiotics such as colistin. Some new beta-lactam antibiotics and beta-lactamase inhibitors, which are active against ESBL, AmpC and some carbapenemase producing organisms, are in advanced clinical development (10). However, these antibiotics are likely to be expensive and may best be held in reserve for infections where there are no alternatives. Therefore, we see a need for establishing the efficacy of a generically available alternative to carbapenems for serious infections.
The susceptibility of ESBL producers and AmpC producers to piperacillin/tazobactam is less predictable than that of carbapenems. By definition, ESBLs are inhibited by beta-lactamase inhibitors such as tazobactam (1). However, E. coli or Klebsiella may produce multiple beta-lactamase types some of which are resistant to inhibition by tazobactam. Additionally, in some cases outer membrane protein loss may contribute to resistance to tazobactam. By definition, AmpC is not inhibited by beta-lactamase inhibitors such as tazobactam. However, despite these limitations, approximately 50% or more of ceftriaxone non-susceptible E. coli or Klebsiellae remain susceptible in vitro to piperacillin/tazobactam (1).
No randomised controlled trials have yet been performed comparing different treatment options for ceftriaxone resistant Enterobacteriaceae. The largest observational study with an analysis by treatment outcome was published in February 2012 by Rodriguez-Bano and colleagues (9). They performed a post-hoc analysis of six published cohorts of patients with bacteraemia due to ESBL producing E. coli. Two nonmutually exclusive cohorts (empirical therapy and definitive therapy) were constructed and analysed separately. In both cohorts, carbapenems were not superior to beta-lactam/beta-lactamase inhibitor combinations (BLBLIC). Specifically, in the definitive therapy cohort, mortality rates at 30 days were not significantly different - 9.3% for those who received a BLBLIC and 16.7% for those who received a carbapenem (p>0.20) (9).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Meropenem | Active comparator | Drug: MeropenemMeropenem 1g adm every 8 hours IV up to study day 4. |
| Piperacillin-tazobactam combination product | Experimental | Drug: Piperacillin-tazobactam combination productPiperacillin/tazobactam 4.5g adm every 6 hours IV up to study day 4. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Bloodstream infection with E. coli or Klebsiella spp. with proven non-susceptibility to third generation cephalosporins and susceptibility to meropenem and piperacillin-tazobactam from at least one blood culture draw. This will be determined in accordance with laboratory methods and susceptibility breakpoints defined by EUCAST standards (www. eucast.org). Bacterial identification to species level will be performed using standard laboratory methods (e.g. MALDI-TOF) and susceptibility testing (e.g. Vitek2)
- No more than 72 hours has elapsed since the first positive blood culture collection.
- Patient is aged 18 years and over
- The patient or approved proxy is able to provide informed consent.
Key exclusion criteria (6 listed)
- Patient not expected to survive more than 4 days
- Patient allergic to a penicillin or a carbapenem
- Patient with significant polymicrobial bacteraemia (that is, a Gram positive skin contaminant in one set of blood cultures is not regarded as significant polymicrobial bacteraemia).
- Treatment is not with the intent to cure the infection (that is, palliative care is an exclusion).
- Pregnancy or breast-feeding.
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 |
|---|---|---|
| MeropenemAlso: Merrem, MeronemMeropenem is a carbapenem anti-bacterial used for the treatment of serious infections in patients. | Drug | Meropenem |
| Piperacillin-tazobactam combination productAlso: Zosyn, TazocinPiperacillin-tazobactam is used for the treatment of patients with systemic and/or local bacterial infections. | Drug | Piperacillin-tazobactam combination product |
Primary outcome
Mortality at 30 days
Time frame: 30 days
To compare the 30-day mortality post bloodstream infection of piperacillin/tazobactam and meropenem.
5 secondary outcomes
Time to clinical and microbiologic resolution of infection
Time frame: on or before study day 4
Clinical and microbiologic success
Time frame: day 4
Microbiologic resolution of infection
Time frame: day 4
Microbiologic relapse
Time frame: day 30
Superinfection with a carbapenem or piperacillin-tazobactam resistant organism or Clostridium Difficile
Time frame: day 30
Results and safety
The study was stopped early (reason given: Secondary to third interim analysis by the study DSMB.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2017.
- Derived from this study: PubMed 30208454Harris PNA, Tambyah PA, Lye DC, Mo Y, Lee TH, Yilmaz M, Alenazi TH, Arabi Y, Falcone M, Bassetti M, Righi E, Rogers BA, Kanj S, Bhally H, Iredell J, Mendelson M, Boyles TH, Looke D, Miyakis S, Walls G, Al Khamis M, Zikri A, Crowe A, Ingram P, Daneman N, Griffin P, Athan E, Lorenc P, Baker P, Roberts L, Beatson SA, Peleg AY, Harris-Brown T, Paterson DL; MERINO Trial Investigators and the Australasian Society for Infectious Disease Clinical Research Network (ASID-CRN). Effect of Piperacillin-Tazobactam vs Meropenem on 30-Day Mortality for Patients With E coli or Klebsiella pneumoniae Bloodstream Infection and Ceftriaxone Resistance: A Randomized Clinical Trial. JAMA. 2018 Sep 11;320(10):984-994. doi: 10.1001/jama.2018.12163.
- Derived from this study: PubMed 25623485Harris PN, Peleg AY, Iredell J, Ingram PR, Miyakis S, Stewardson AJ, Rogers BA, McBryde ES, Roberts JA, Lipman J, Athan E, Paul SK, Baker P, Harris-Brown T, Paterson DL. Meropenem versus piperacillin-tazobactam for definitive treatment of bloodstream infections due to ceftriaxone non-susceptible Escherichia coli and Klebsiella spp (the MERINO trial): study protocol for a randomised controlled trial. Trials. 2015 Jan 27;16:24. doi: 10.1186/s13063-014-0541-9.
Related trials for Bloodstream Infections
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
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 L Paterson, MD, PhD principal investigator
UQCCR, RBWH
31 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Meropenem and Piperacillin-tazobactam combination product in people with Bloodstream Infections, run by The University of Queensland at 31 sites in 9 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 4 inclusion and 6 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: stopped early, as of the sponsor's last update on 27 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in Australia, Italy, New Zealand, Saudi Arabia, Singapore and 4 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?
The study was stopped early (reason given: Secondary to third interim analysis by the study DSMB.). Results are not available in the source record.
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 30 days (time frame: 30 days). 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 NCT02176122, 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 27 Nov 2017.