LeukemiaPhase 4NCT02095951
Preemptive Ethanol Lock Therapy in Pediatric Bloodstream Infection
A Phase 4 study testing Ethanol lock therapy (ELT) in people with Leukemia and Lymphoma, run by Children's Hospital of Michigan at 1 site in United States.
Trial summary
The study team will compare hospital length of stay (LOS) and attributable length of stay (ALOS, the LOS attributable to CRI), in a randomized, un-blinded prospective trial utilizing short-dwell ethanol-lock therapy (ELT) (4 hours to 24 hour dwell times per day, repeated for up to 72 hours) placed within 24 - 36 hours… Read more about this study
- Who is it for?
- Ages 6 months to 21 years
- Conditions the study is for
- Leukemia, Lymphoma, Blood Disorders
- What is being tested?
- Ethanol lock therapy (ELT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Jun 2016
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 6 months to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- All children up to 21 years of age, with central catheters (any type) that develop symptoms and are admitted to CHM with an underlying H/O/BMT diagnosis for individual episodes of suspected or proven CRI of the blood, including rule out sepsis, will be screened for potential participation in this study.
- Individual CRI episodes in the same patient will be defined as a distinct central catheter associated blood stream infection if separated by greater than 28 days from prior ELT procedure and caused by a different organism identified on culture than the prior central catheter associated blood stream infection episode.
- Participants meeting study enrollment criteria will be offered participation and must have parental full informed consent, adolescent assent and young child verbal assent prior to enrollment as applicable.
Who cannot join
- Children with documented allergy to ethanol or alcohol will be excluded. Blood cultures from patients that are reported positive for pathogen growth within 12 hours from the time they are obtained will be excluded from the study.
- Any patient at CHM with an infected central catheter and with another indwelling foreign body that communicates directly with the bloodstream, of which infection or colonization could not be excluded directly, will also be excluded from the study (i.e. Left Ventricular Assist Device) as it will not be possible to assess sterilization of the central catheter.
- Any patient with endocarditis or presumed endovascular infection will also be excluded.
- Any patient deemed critically ill or unstable, upon admission or during the early treatment course, in which case the treating clinician(s) feel that immediate line removal is potentially life-saving will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Michigan
Detroit, Michigan, 48201
About this study
Official title: Preemptive Ethanol Lock Therapy in Pediatric Hematology/Oncology Patients With Catheter Associated Bloodstream Infection: Impact on Length of Stay and Catheter Salvage
The study team will compare hospital length of stay (LOS) and attributable length of stay (ALOS, the LOS attributable to CRI), in a randomized, un-blinded prospective trial utilizing short-dwell ethanol-lock therapy (ELT) (4 hours to 24 hour dwell times per day, repeated for up to 72 hours) placed within 24 - 36 hours of admission(Group 1, Preemptive ELT) versus ELT placed at the time of first positive blood culture report (Group 2, Rescue ELT (Standard of Care ). ELT will be given in both groups, in combination with systemic antibiotics, for the treatment of CRI (suspected or proven) of the blood in children with central catheters. Participants will be enrolled from patients with hematologic/oncologic disorders and bone marrow or hematopoetic stem cell transplants (BMT) admitted for care to Children's Hospital of Michigan (CHM), a tertiary care pediatric hospital in Detroit, Michigan. ALOS will be defined as the number of hospital days between first symptoms of Catheter-related infection (CRI) (or date of admission for those admitted with symptoms) and first negative blood culture.
Study Hypothesis: The main hypothesis is that the short-dwell ethanol-lock therapy, defined above, placed within 24 - 36 hours of symptoms/admission (Arm 1) versus ELT placement at the time of first positive blood culture report (Arm 2), with concomitant systemic antibiotics, for the treatment of CRI (suspected or proven) of the blood in children with central catheters in the H/O/BMT population will have shorter hospital length of stay (LOS) and attributable LOS (ALOS) and therefore lower hospital costs.
Read the detailed description
The study team will compare hospital length of stay (LOS) and attributable length of stay (ALOS, the LOS attributable to CRI), in a randomized, un-blinded prospective trial utilizing short-dwell ethanol-lock therapy (ELT) (4 hours to 24 hour dwell times per day, repeated for up to 72 hours) placed within 24 - 36 hours of admission(Group 1, Preemptive ELT) versus ELT placed at the time of first positive blood culture report (Group 2, Rescue ELT (Standard of Care ).
ELT will be given in both groups, in combination with systemic antibiotics, for the treatment of Catheter-related Infection (CRI) (suspected or proven) of the blood in children with central catheters. Participants will be enrolled from patients with hematologic/oncologic disorders and bone marrow or hematopoetic stem cell transplants admitted for care to Children's Hospital of Michigan (CHM), a tertiary care pediatric hospital in Detroit, Michigan. ALOS will be defined as the number of hospital days between first symptoms of CRI (or date of admission for those admitted with symptoms) and first negative blood culture.
Aim 1: Compare two different treatment regimens for CRI using ELT (the preemptive ELT vs. standard of care) by way of a prospective, randomized, two-arm study.
Study Hypothesis: The main hypothesis is that the short-dwell ethanol-lock therapy, defined above, placed within 24 - 36 hours of symptoms/admission (Arm 1) versus ELT placement at the time of first positive blood culture report (Arm 2), with concomitant systemic antibiotics, for the treatment of CRI (suspected or proven) of the blood in children with central catheters in the H/O/BMT population will have shorter hospital length of stay (LOS) and attributable LOS (ALOS) and therefore lower hospital costs.
Aim 2: Compare sterilization rate of the infected intravascular device after ethanol-lock therapy (as defined by a negative blood culture obtained from the infected catheter 24 - 72 hours after ELT) and central catheter salvage rate after CRI using ELT in the two study arms. If the central catheter is salvaged for further clinical use, recurrence of infection with the same organism (re-infection) of the central catheter for 28 days from date of first ELT procedure will also be assessed.
Aim 3: Assess tolerability and adverse effects of the ELT (safety).
Aim 4: Perform sub-group analysis on the BSI episodes meeting National Healthcare Safety Network (NHSN) criteria for laboratory confirmed central line associated BSI (CLABSI) into the three categories of Criteria 1, 2 or 3 within the pediatric
- Conditions
- Leukemia, Lymphoma, Blood Disorders, Solid Tumors
- Being tested
- Ethanol lock therapy (ELT)
- Medical subject headings
- Leukemia, Lymphoma, Hematologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ethanol lock therapy (ELT)Drug
Also called 70% Ethanol in water
Participants will be randomized to receive early (preemptive) ELT (after 12 hours from time blood culture drawn, but before blood culture positive, R/O sepsis) with systemic antimicrobials versus standard ELT (placed in catheter when blood culture is positive for growth of a germ) with systemic antimicrobials.
| Study group | Role | What they receive |
|---|---|---|
| Pre-emptive Ethanol Lock Therapy Group | Experimental | Participants receive ethanol lock before blood cultures grow germ Receives: Drug: Ethanol lock therapy (ELT) |
| Standard Ethanol Lock Therapy Group | Active comparator | Participants receive ethanol lock if and only after blood cultures grow germ Receives: Drug: Ethanol lock therapy (ELT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of Stay (LOS) in Those With 14 Confirmed Catheter Related Infection Cases
A primary endpoint of this study is length of stay (LOS) per catheter infection episode/admission
Measured: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Attributable Length of Stay (ALOS) in 14 Confirmed Catheter Related Infection Cases
TIME FROM FIRST POSITIVE TO FIRST NEGATIVE BLOOD CULTURE
Measured: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Hospital COSTS in 14 Confirmed Catheter Related Infection Cases
Hospital COSTS
Measured: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Secondary outcomes (4)
Catheter Sterilization
Number of Catheters sterilized with interventions
Measured: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Catheter Salvage
Number of Infected catheters (which achieved sterilization) with salvage for at least 14 days.
Measured: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Number of Adverse Events Per Episode of Catheter Infection
Number of Adverse events per episode of distinct catheter infection that are thought to be related to the actual study intervention, namely timing of ethanol lock placement, will be reviewed and reported for each individual infection episode/admission.
Measured: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks but up to 1 month post the last ethanol dose administration
Re-infection
Number of Re-Infected of salvaged catheters with same or new organism(s) within 28 days of prior CRI/ELT
Measured: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks but for up to 1 month total
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2014 (estimated)
- Study startJun 2014
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for LeukemiaStudies 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Blue Cross Blue Shield of Michigan Foundation
- Responsible party
- Principal investigator, Eric McGrath, Children's Hospital of Michigan
- Investigators
- Eric J McGrath, MD, Principal investigator, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02095951
- Sponsor's protocol ID
- 2024.11
- Status last verified
- Aug 2018
- First submitted
- 17 Mar 2014
- Last updated
- 19 Dec 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
McGrath EJ, Salloum R, Chen X, Jiang Y, Boldt-MacDonald K, Becker C, Chu R, Ang JY. Short-dwell ethanol lock therapy in children is associated with increased clearance of central line-associated bloodstream infections. Clin Pediatr (Phila). 2011 Oct;50(10):943-51. doi: 10.1177/0009922811409568. Epub 2011 May 27.
PubMed 21622689Chaudhary M, Bilal MF, Du W, Chu R, Rajpurkar M, McGrath EJ. The impact of ethanol lock therapy on length of stay and catheter salvage in pediatric catheter-associated bloodstream infection. Clin Pediatr (Phila). 2014 Oct;53(11):1069-76. doi: 10.1177/0009922814533591. Epub 2014 May 7.
PubMed 24807976Rajpurkar M, McGrath E, Joyce J, Boldt-MacDonald K, Chitlur M, Lusher J. Therapeutic and prophylactic ethanol lock therapy in patients with bleeding disorders. Haemophilia. 2014 Jan;20(1):52-7. doi: 10.1111/hae.12241. Epub 2013 Aug 1.
PubMed 23906245McGrath E, Du W, Rajpurkar M. Preemptive Ethanol Lock Therapy in Pediatric Hematology/Oncology Patients With Catheter-Associated Bloodstream Infection: Impact on Length of Stay, Cost, and Catheter Salvage. Clin Pediatr (Phila). 2018 Mar;57(3):285-293. doi: 10.1177/0009922817717327. Epub 2017 Jun 30.
PubMed 28664750
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preemptive Ethanol Lock Therapy in Pediatric Hematology/Oncology Patients With Catheter Associated Bloodstream Infection: Impact on Length of Stay and Catheter Salvage
- ClinicalTrials.gov ID
- NCT02095951
- Acronym / sponsor ID
- 2024.11
- Conditions
- Leukemia, Lymphoma, Blood Disorders, Solid Tumors
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Children's Hospital of MichiganUniversity, hospital or other
- Collaborators
- Blue Cross Blue Shield of Michigan Foundation
- Study start
- Jun 2014
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 26 Mar 2014 (estimated)
- Results
- Posted 19 Dec 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study team will compare hospital length of stay (LOS) and attributable length of stay (ALOS, the LOS attributable to CRI), in a randomized, un-blinded prospective trial utilizing short-dwell ethanol-lock therapy (ELT) (4 hours to 24 hour dwell times per day, repeated for up to 72 hours) placed within 24 - 36 hours of admission(Group 1, Preemptive ELT) versus ELT placed at the time of first positive blood culture report (Group 2, Rescue ELT (Standard of Care ). ELT will be given in both groups, in combination with systemic antibiotics, for the treatment of CRI (suspected or proven) of the blood in children with central catheters. Participants will be enrolled from patients with hematologic/oncologic disorders and bone marrow or hematopoetic stem cell transplants (BMT) admitted for care to Children's Hospital of Michigan (CHM), a tertiary care pediatric hospital in Detroit, Michigan. ALOS will be defined as the number of hospital days between first symptoms of Catheter-related infection (CRI) (or date of admission for those admitted with symptoms) and first negative blood culture.
Study Hypothesis: The main hypothesis is that the short-dwell ethanol-lock therapy, defined above, placed within 24 - 36 hours of symptoms/admission (Arm 1) versus ELT placement at the time of first positive blood culture report (Arm 2), with concomitant systemic antibiotics, for the treatment of CRI (suspected or proven) of the blood in children with central catheters in the H/O/BMT population will have shorter hospital length of stay (LOS) and attributable LOS (ALOS) and therefore lower hospital costs.
Detailed description
The study team will compare hospital length of stay (LOS) and attributable length of stay (ALOS, the LOS attributable to CRI), in a randomized, un-blinded prospective trial utilizing short-dwell ethanol-lock therapy (ELT) (4 hours to 24 hour dwell times per day, repeated for up to 72 hours) placed within 24 - 36 hours of admission(Group 1, Preemptive ELT) versus ELT placed at the time of first positive blood culture report (Group 2, Rescue ELT (Standard of Care ).
ELT will be given in both groups, in combination with systemic antibiotics, for the treatment of Catheter-related Infection (CRI) (suspected or proven) of the blood in children with central catheters. Participants will be enrolled from patients with hematologic/oncologic disorders and bone marrow or hematopoetic stem cell transplants admitted for care to Children's Hospital of Michigan (CHM), a tertiary care pediatric hospital in Detroit, Michigan. ALOS will be defined as the number of hospital days between first symptoms of CRI (or date of admission for those admitted with symptoms) and first negative blood culture.
Aim 1: Compare two different treatment regimens for CRI using ELT (the preemptive ELT vs. standard of care) by way of a prospective, randomized, two-arm study.
Study Hypothesis: The main hypothesis is that the short-dwell ethanol-lock therapy, defined above, placed within 24 - 36 hours of symptoms/admission (Arm 1) versus ELT placement at the time of first positive blood culture report (Arm 2), with concomitant systemic antibiotics, for the treatment of CRI (suspected or proven) of the blood in children with central catheters in the H/O/BMT population will have shorter hospital length of stay (LOS) and attributable LOS (ALOS) and therefore lower hospital costs.
Aim 2: Compare sterilization rate of the infected intravascular device after ethanol-lock therapy (as defined by a negative blood culture obtained from the infected catheter 24 - 72 hours after ELT) and central catheter salvage rate after CRI using ELT in the two study arms. If the central catheter is salvaged for further clinical use, recurrence of infection with the same organism (re-infection) of the central catheter for 28 days from date of first ELT procedure will also be assessed.
Aim 3: Assess tolerability and adverse effects of the ELT (safety).
Aim 4: Perform sub-group analysis on the BSI episodes meeting National Healthcare Safety Network (NHSN) criteria for laboratory confirmed central line associated BSI (CLABSI) into the three categories of Criteria 1, 2 or 3 within the pediatric
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-emptive Ethanol Lock Therapy Group | Experimental | Drug: Ethanol lock therapy (ELT)Participants receive ethanol lock before blood cultures grow germ |
| Standard Ethanol Lock Therapy Group | Active comparator | Drug: Ethanol lock therapy (ELT)Participants receive ethanol lock if and only after blood cultures grow germ |
Who may qualify
- Ages
- 6 months to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- All children up to 21 years of age, with central catheters (any type) that develop symptoms and are admitted to CHM with an underlying H/O/BMT diagnosis for individual episodes of suspected or proven CRI of the blood, including rule out sepsis, will be screened for potential participation in this study.
- Individual CRI episodes in the same patient will be defined as a distinct central catheter associated blood stream infection if separated by greater than 28 days from prior ELT procedure and caused by a different organism identified on culture than the prior central catheter associated blood stream infection episode.
- Participants meeting study enrollment criteria will be offered participation and must have parental full informed consent, adolescent assent and young child verbal assent prior to enrollment as applicable.
Key exclusion criteria (4 listed)
- Children with documented allergy to ethanol or alcohol will be excluded. Blood cultures from patients that are reported positive for pathogen growth within 12 hours from the time they are obtained will be excluded from the study.
- Any patient at CHM with an infected central catheter and with another indwelling foreign body that communicates directly with the bloodstream, of which infection or colonization could not be excluded directly, will also be excluded from the study (i.e. Left Ventricular Assist Device) as it will not be possible to assess sterilization of the central catheter.
- Any patient with endocarditis or presumed endovascular infection will also be excluded.
- Any patient deemed critically ill or unstable, upon admission or during the early treatment course, in which case the treating clinician(s) feel that immediate line removal is potentially life-saving will be excluded from the study.
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 |
|---|---|---|
| Ethanol lock therapy (ELT)Also: 70% Ethanol in waterParticipants will be randomized to receive early (preemptive) ELT (after 12 hours from time blood culture drawn, but before blood culture positive, R/O sepsis) with systemic antimicrobials versus standard ELT (placed in catheter when blood culture is positive for growth of a germ) with systemic antimicrobials. | Drug | Pre-emptive Ethanol Lock Therapy Group, Standard Ethanol Lock Therapy Group |
Primary outcome
Length of Stay (LOS) in Those With 14 Confirmed Catheter Related Infection Cases
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
A primary endpoint of this study is length of stay (LOS) per catheter infection episode/admission
Attributable Length of Stay (ALOS) in 14 Confirmed Catheter Related Infection Cases
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
TIME FROM FIRST POSITIVE TO FIRST NEGATIVE BLOOD CULTURE
Hospital COSTS in 14 Confirmed Catheter Related Infection Cases
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Hospital COSTS
4 secondary outcomes
Catheter Sterilization
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Catheter Salvage
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Number of Adverse Events Per Episode of Catheter Infection
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks but up to 1 month post the last ethanol dose administration
Re-infection
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks but for up to 1 month total
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21622689McGrath EJ, Salloum R, Chen X, Jiang Y, Boldt-MacDonald K, Becker C, Chu R, Ang JY. Short-dwell ethanol lock therapy in children is associated with increased clearance of central line-associated bloodstream infections. Clin Pediatr (Phila). 2011 Oct;50(10):943-51. doi: 10.1177/0009922811409568. Epub 2011 May 27.
- Background: PubMed 24807976Chaudhary M, Bilal MF, Du W, Chu R, Rajpurkar M, McGrath EJ. The impact of ethanol lock therapy on length of stay and catheter salvage in pediatric catheter-associated bloodstream infection. Clin Pediatr (Phila). 2014 Oct;53(11):1069-76. doi: 10.1177/0009922814533591. Epub 2014 May 7.
- Background: PubMed 23906245Rajpurkar M, McGrath E, Joyce J, Boldt-MacDonald K, Chitlur M, Lusher J. Therapeutic and prophylactic ethanol lock therapy in patients with bleeding disorders. Haemophilia. 2014 Jan;20(1):52-7. doi: 10.1111/hae.12241. Epub 2013 Aug 1.
- Results publication: PubMed 28664750McGrath E, Du W, Rajpurkar M. Preemptive Ethanol Lock Therapy in Pediatric Hematology/Oncology Patients With Catheter-Associated Bloodstream Infection: Impact on Length of Stay, Cost, and Catheter Salvage. Clin Pediatr (Phila). 2018 Mar;57(3):285-293. doi: 10.1177/0009922817717327. Epub 2017 Jun 30.
- Individual participant dataSharing planned: Undecided
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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.
Eric J McGrath, MD principal investigator
Wayne State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ethanol lock therapy (ELT) in people with Leukemia and Lymphoma, run by Children's Hospital of Michigan at 1 site in United States.
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 3 inclusion and 4 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 19 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Yes. Results are posted in the registry (first posted 19 Dec 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Length of Stay (LOS) in Those With 14 Confirmed Catheter Related Infection Cases (time frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks). The study lists 3 primary outcomes in all. 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 NCT02095951, which also lists 4 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 19 Dec 2018.