BacteremiaBALANCENCT02261506
Bacteremia Antibiotic Length Actually Needed for Clinical Effectiveness: A Pilot RCT
A study testing 7 days of adequate antibiotic treatment durations and 14 days of adequate antibiotic treatment durations in people with Bacteremia, run by Sunnybrook Health Sciences Centre at 17 sites in Canada.
Trial summary
Bacteremia is a leading cause of mortality and morbidity in critically ill adults. Although bacteria in the bloodstream (bacteremia) may arise from variable infectious foci (most commonly central vascular catheter related, lung, urinary tract, intra-abdominal, or skin and soft tissue sources), because of the high… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bacteremia
- What is being tested?
- 7 days of adequate antibiotic treatment durations and 14 days of adequate antibiotic treatment durations
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 17 sitesCanada
- Study dates
- 16 Oct 2014to 5 Oct 2017
- Phase
- Interventional
- 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
- Patient is in the ICU at time the blood culture result reported as positive AND
- Patient has a positive blood culture with pathogenic bacteria.
Who cannot join
- Patient already enrolled in the trial
- Patient has severe immune system compromise, as defined by: absolute neutrophil count <0.5x109/L; or is receiving immunosuppressive treatment for solid organ or bone marrow or stem cell transplant
- Patient has syndrome with well-defined requirement for prolonged treatment:
- infective endocarditis
- osteomyelitis/septic arthritis
- undrainable/undrained abscess
Show all 10Show fewer
- unremovable/unremoved prosthetic-associated infection
- Patient has a single positive blood culture with a common contaminant organism according to Clinical Laboratory \& Standards Institute (CLSI) Guidelines: coagulase negative staphylococci; or Bacillus spp.; or Corynebacterium spp.; or Propionobacterium spp.; or Aerococcus spp.; or Micrococcus spp.
- Patient has a positive blood culture with Staphylococcus aureus.
- Patient has a positive blood culture with Candida spp. or other fungal species.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
Canada17 sites
Foothills Hospital
Calgary, Alberta
University of Alberta Hospital
Edmonton, Alberta
Queen Elizabeth II Hospital
Halifax, Nova Scotia
Kingston General Hospital
Kingston, Ontario
London Health Sciences Centre
London, Ontario
CHUM
Montreal, Quebec
The Ottawa Hospital
Ottawa, Ontario
Centre hospitalier affilié universitaire de Québec
Québec, Quebec
CSSS de Trois-Rivières
Québec, Quebec
Université de Sherbrooke
Sherbrooke, Quebec
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N3M5
Mount Sinai Hospital
Toronto, Ontario
St. Michael's Hospital
Toronto, Ontario
Toronto Western Hospital
Toronto, Ontario
Royal Columbian Hospital
Vancouver, British Columbia
St. Paul's Hospital
Vancouver, British Columbia
St. Boniface Hospital
Winnipeg, Manitoba
About this study
Bacteremia is a leading cause of mortality and morbidity in critically ill adults. Although bacteria in the bloodstream (bacteremia) may arise from variable infectious foci (most commonly central vascular catheter related, lung, urinary tract, intra-abdominal, or skin and soft tissue sources), because of the high attendant morbidity and mortality of bacteremia, these patients collectively represent a critically important group to study.
The consequences of the excessive antimicrobial use for individual patients, range from rash, gastrointestinal upset and diarrhea, to anaphylaxis, neutropenia, renal failure, toxic epidermal necrolysis, death, and a marked increase in ICU and hospital drug costs. One particularly concerning complication, Clostridium difficile infection, has increased in incidence and severity over the past decade. Much of this burden could be prevented through reduction in unnecessary antibiotic use.
Read more
Another major consequence of excessive antibiotic use is antimicrobial resistance. Antibiotic resistance is not only a concern for the patient who receives antibiotics, but also for neighbouring patients in the ICU, as well as future patients in the ICU and the hospital at large - through patient-to-patient transmission, and environmental contamination.
No previous randomized controlled trials have directly compared shorter versus longer durations of antimicrobial treatment in these patients. The investigators will conduct a multi-center randomized concealed allocation trial of shorter duration (7 days) versus longer duration (14 days) antibiotic treatment for critically ill patients with bacteremia admitted to ICU. Eligible, patients will be randomized to either 7 days or 14 days of adequate antimicrobial treatment. The selection of type, dose and route of antibiotics will be at the discretion of the treating physicians, but the duration of treatment (7 versus 14 days) will be determined by randomization group. The randomization assignment will not be communicated to the study research coordinator, study critical care or infectious diseases investigators or clinicians until day 8. The primary outcome for the main trial will be 90-day mortality.
The study will be initiated at Sunnybrook Health Sciences Centre in Toronto, Ontario, and then rolled out to a second site at Kingston General Hospital in Kingston, Ontario. These sites will be sufficient to meet the sample size goals for the pilot RCT, but if additional funds are obtained the investigators will also roll out to the other Canadian ICUs listed below. The goal of adding these additional sites will be to increase the generalizability of the findings with respect to trial feasibility
- Conditions
- Bacteremia
- Being tested
- 7 days of adequate antibiotic treatment durations, 14 days of adequate antibiotic treatment durations
- Keywords
- Intensive care, bacteremia, bloodstream infection, antimicrobial, mortality, antimicrobial stewardship
- Medical subject headings
- Bacteremia, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
7 days of adequate antibiotic treatment durationsOther
We will not be randomizing patients to any specific antibiotic regimen. Patients will be randomized to fixed durations of adequate treatment: 7 versus 14 days. The selection of antibiotic(s) will be at the discretion of the treating team, although the research team will check to ensure that the selected antibiotics have an 'adequate' spectrum of coverage for the bacterial pathogen(s) isolated in the blood culture.
14 days of adequate antibiotic treatment durationsOther
| Study group | Role | What they receive |
|---|---|---|
| 7 days | Active comparator | Patients in 7 day arm will receive adequate antibiotics until the end of day 7 only Receives: Other: 7 days of adequate antibiotic treatment durations |
| 14 days | Active comparator | Patients in 14 day arm will receive adequate antibiotics until the end of day 14 only Receives: Other: 14 days of adequate antibiotic treatment durations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to treatment duration protocol (proportion of treatment courses)
We will consider the main trial to be feasible and worthy of embarking on a larger mortality-powered RCT if 90% of antibiotic treatment courses are within 7± 2 days in the shorter duration treatment arm or 14 ± 2 days in the longer duration treatment arm.
Measured: 15 days
Rate of recruitment (patients per site, per month)
We will consider the main trial to be feasible if we achieve recruitment rates of at least 1 patient per 4 weeks, on average, per participating site.
Measured: For up to 1 year
Secondary outcomes (14)
ICU mortality
Measured: Recorded as alive or dead at ICU discharge following index positive blood culture for an expected average of 2 weeks assesses upto one year.
Hospital mortality
Measured: recorded as alive or dead at hospital discharge following index positive blood culture for an expected average of 4 weeks assesses upto one year.
90 day mortality
Measured: Recorded as alive or dead at 90 days following index positive blood culture
Relapse rates of bacteremia
Defined as the recurrence of bacteremia due to original infecting organism (same Genus and species) after documentation of negative blood cultures or clinical improvement and within 30 days after completing course of adequate antimicrobial therapy.
Measured: Upto 30 days after adequate antibiotic treatment
Antibiotic allergy
Effect of medication on body that produces the allergic reaction to a medication like:
- Hives
- Itching of the skin or eyes
- Skin rash
- Swelling of the lips, tongue, or face
- Wheezing
Measured: Up to 30 days from start of antibiotic treatment.
Anaphylaxis
To be considered anaphylaxis, the patient must have had >=1 of the following 3 criteria that a medical team member attributed to an Antimicrobial
- Acute onset of skin or mucosal tissue changes (hives, itching/flush, lip/tongue/uvula swelling) over minutes/hours, accompanied by
- respiratory compromise (dyspnea, wheeze, stridor, hypoxemia), AND/OR
- reduced blood pressure or symptoms/signs of end organ dysfunction from shock
- Rapid onset of two or more of the following
- involvement of the skin-mucosa (hives, itch//flush, swollen lips/tongue/uvula)
- respiratory compromise
- reduced BP or associated symptoms/signs
- persistent gastrointestinal symptoms/signs (crampy abdominal pain, vomiting)
- Reduced blood pressure after exposure to a known allergen for that patient
Measured: Up to 30 days from start of antibiotic treatment
Antimicrobial-related acute kidney injury
To be considered Antimicrobial-associated renal injury, a medical team member must have attributed the renal injury to the Antimicrobial, and the severity of the renal injury must meet one of these (RIFLE criteria):
- Risk: GFR decrease >25%, serum creatinine increased 1.5 times or urine production of <0.5 ml/kg/hr for 6 hours
- Injury: GFR decrease >50%, doubling of creatinine or urine production <0.5 ml/kg/hr for 12 hours
- Failure: GFR decrease >75%, tripling of creatinine or creatinine >355 μmol/l (with a rise of >44) (>4 mg/dl) OR urine output below 0.3 ml/kg/hr for 24 hours
- Loss: persistent AKI or complete loss of kidney function for more than 4 weeks
- End-stage renal disease: need for renal replacement therapy (RRT) for more than 3 months
Measured: Up to 30 days from start of antibiotic treatment
Antimicrobial-related hepatitis
To be considered Antimicrobial-associated hepatitis, a medical team member must have attributed the hepatitis to the Antimicrobial, and the severity of the hepatitis must meet this FDA criteria for hepatic adverse events:
- ALT> 3x the upper limit of normal
Measured: Up to 30 days from start of antibiotic treatment
Rates of Clostridium difficile infection in hospital
Defined as a positive PCR or ELISA test for Clostridium difficile toxin in the context of diarrhea within hospital of bacteremia diagnosis.
Measured: Upto 30 days after index blood culture collection date
Rates of secondary nosocomial infection with antimicrobial resistant organisms in hospital
Measured: Upto 30 days after index blood culture collection date
ICU lengths of stay
Measured: For the duration of ICU stay, expected for an average of 30 days assessed up to 1 year.
Hospital lengths of stay
Measured: For the duration of Hospital stay, expected for an average of 30 days assessed up to 1 year.
Mechanical ventilation duration
Defined as the number of consecutive days receiving invasive (via an endotracheal tube or tracheostomy), or non-invasive (via a facemask, nasal mask, or helmet) ventilation. Durations will be calculated for all patients then separately for patients who died within hospital and those who did not die.
Measured: For the duration of ICU and Hospital stay, expected for an average of 30 days
Vasopressor duration in ICU
Defined as the number of consecutive days receiving intravenous vasoactive medications (e.g. epinephrine, norepinephrine, vasopressin, dopamine, phenylephrine, dobutamine, milrinone). Durations will be calculated for all patients then separately for patients who died within hospital and those who did not die.
Measured: For the duration of ICU and Hospital stay, expected for an average of 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2014 (estimated)
- Study start16 Oct 2014
- Primary completion30 Aug 2017
- Study completion5 Oct 2017
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 BacteremiaStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Kingston Health Sciences Centre
- Responsible party
- Principal investigator, Dr. Nick Daneman, Sunnybrook Health Sciences Centre
- Investigators
- Nick Daneman, MD, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02261506
- Sponsor's protocol ID
- 187-2014
- Acronym
- BALANCE
- Status last verified
- Dec 2017
- First submitted
- 26 Sep 2014
- Last updated
- 18 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Daneman N, Rishu AH, Pinto R, Aslanian P, Bagshaw SM, Carignan A, Charbonney E, Coburn B, Cook DJ, Detsky ME, Dodek P, Hall R, Kumar A, Lamontagne F, Lauzier F, Marshall JC, Martin CM, McIntyre L, Muscedere J, Reynolds S, Sligl W, Stelfox HT, Wilcox ME, Fowler RA; Canadian Critical Care Trials Group. 7 versus 14 days of antibiotic treatment for critically ill patients with bloodstream infection: a pilot randomized clinical trial. Trials. 2018 Feb 17;19(1):111. doi: 10.1186/s13063-018-2474-1.
PubMed 29452598Daneman N, Rishu AH, Xiong W, Bagshaw SM, Cook DJ, Dodek P, Hall R, Kumar A, Lamontagne F, Lauzier F, Marshall JC, Martin CM, McIntyre L, Muscedere J, Reynolds S, Stelfox HT, Fowler RA; Canadian Critical Care Trials Group. Bacteremia Antibiotic Length Actually Needed for Clinical Effectiveness (BALANCE): study protocol for a pilot randomized controlled trial. Trials. 2015 Apr 18;16:173. doi: 10.1186/s13063-015-0688-z.
PubMed 25903783
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bacteremia Antibiotic Length Actually Needed for Clinical Effectiveness: A Pilot RCT
- ClinicalTrials.gov ID
- NCT02261506
- Acronym / sponsor ID
- BALANCE / 187-2014
- Conditions
- Bacteremia
- Keywords
- Intensive care, bacteremia, bloodstream infection, antimicrobial, mortality, antimicrobial stewardship
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Collaborators
- Kingston Health Sciences Centre
- Study start
- 16 Oct 2014 (actual)
- Primary completion
- 30 Aug 2017 (actual)
- Study completion
- 5 Oct 2017 (actual)
- First posted
- 10 Oct 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.
Bacteremia is a leading cause of mortality and morbidity in critically ill adults. Although bacteria in the bloodstream (bacteremia) may arise from variable infectious foci (most commonly central vascular catheter related, lung, urinary tract, intra-abdominal, or skin and soft tissue sources), because of the high attendant morbidity and mortality of bacteremia, these patients collectively represent a critically important group to study.
The consequences of the excessive antimicrobial use for individual patients, range from rash, gastrointestinal upset and diarrhea, to anaphylaxis, neutropenia, renal failure, toxic epidermal necrolysis, death, and a marked increase in ICU and hospital drug costs. One particularly concerning complication, Clostridium difficile infection, has increased in incidence and severity over the past decade. Much of this burden could be prevented through reduction in unnecessary antibiotic use.
Another major consequence of excessive antibiotic use is antimicrobial resistance. Antibiotic resistance is not only a concern for the patient who receives antibiotics, but also for neighbouring patients in the ICU, as well as future patients in the ICU and the hospital at large - through patient-to-patient transmission, and environmental contamination.
No previous randomized controlled trials have directly compared shorter versus longer durations of antimicrobial treatment in these patients. The investigators will conduct a multi-center randomized concealed allocation trial of shorter duration (7 days) versus longer duration (14 days) antibiotic treatment for critically ill patients with bacteremia admitted to ICU. Eligible, patients will be randomized to either 7 days or 14 days of adequate antimicrobial treatment. The selection of type, dose and route of antibiotics will be at the discretion of the treating physicians, but the duration of treatment (7 versus 14 days) will be determined by randomization group. The randomization assignment will not be communicated to the study research coordinator, study critical care or infectious diseases investigators or clinicians until day 8. The primary outcome for the main trial will be 90-day mortality.
The study will be initiated at Sunnybrook Health Sciences Centre in Toronto, Ontario, and then rolled out to a second site at Kingston General Hospital in Kingston, Ontario. These sites will be sufficient to meet the sample size goals for the pilot RCT, but if additional funds are obtained the investigators will also roll out to the other Canadian ICUs listed below. The goal of adding these additional sites will be to increase the generalizability of the findings with respect to trial feasibility
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 7 days | Active comparator | Other: 7 days of adequate antibiotic treatment durationsPatients in 7 day arm will receive adequate antibiotics until the end of day 7 only |
| 14 days | Active comparator | Other: 14 days of adequate antibiotic treatment durationsPatients in 14 day arm will receive adequate antibiotics until the end of day 14 only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient is in the ICU at time the blood culture result reported as positive AND
- Patient has a positive blood culture with pathogenic bacteria.
Key exclusion criteria (10 listed)
- Patient already enrolled in the trial
- Patient has severe immune system compromise, as defined by: absolute neutrophil count <0.5x109/L; or is receiving immunosuppressive treatment for solid organ or bone marrow or stem cell transplant
- Patient has syndrome with well-defined requirement for prolonged treatment:
- Patient has a single positive blood culture with a common contaminant organism according to Clinical Laboratory \& Standards Institute (CLSI) Guidelines: coagulase negative staphylococci; or Bacillus spp.; or Corynebacterium spp.; or Propionobacterium spp.; or Aerococcus spp.; or Micrococcus spp.
- Patient has a positive blood culture with Staphylococcus aureus.
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 |
|---|---|---|
| 7 days of adequate antibiotic treatment durationsWe will not be randomizing patients to any specific antibiotic regimen. Patients will be randomized to fixed durations of adequate treatment: 7 versus 14 days. The selection of antibiotic(s) will be at the discretion of the treating team, although the research team will check to ensure that the selected antibiotics have an 'adequate' spectrum of coverage for the bacterial pathogen(s) isolated in the blood culture. | Other | 7 days |
| 14 days of adequate antibiotic treatment durations | Other | 14 days |
Primary outcome
Adherence to treatment duration protocol (proportion of treatment courses)
Time frame: 15 days
We will consider the main trial to be feasible and worthy of embarking on a larger mortality-powered RCT if 90% of antibiotic treatment courses are within 7± 2 days in the shorter duration treatment arm or 14 ± 2 days in the longer duration treatment arm.
Rate of recruitment (patients per site, per month)
Time frame: For up to 1 year
We will consider the main trial to be feasible if we achieve recruitment rates of at least 1 patient per 4 weeks, on average, per participating site.
14 secondary outcomes
ICU mortality
Time frame: Recorded as alive or dead at ICU discharge following index positive blood culture for an expected average of 2 weeks assesses upto one year.
Hospital mortality
Time frame: recorded as alive or dead at hospital discharge following index positive blood culture for an expected average of 4 weeks assesses upto one year.
90 day mortality
Time frame: Recorded as alive or dead at 90 days following index positive blood culture
Relapse rates of bacteremia
Time frame: Upto 30 days after adequate antibiotic treatment
Antibiotic allergy
Time frame: Up to 30 days from start of antibiotic treatment.
Anaphylaxis
Time frame: Up to 30 days from start of antibiotic treatment
Antimicrobial-related acute kidney injury
Time frame: Up to 30 days from start of antibiotic treatment
Antimicrobial-related hepatitis
Time frame: Up to 30 days from start of antibiotic treatment
Rates of Clostridium difficile infection in hospital
Time frame: Upto 30 days after index blood culture collection date
Rates of secondary nosocomial infection with antimicrobial resistant organisms in hospital
Time frame: Upto 30 days after index blood culture collection date
ICU lengths of stay
Time frame: For the duration of ICU stay, expected for an average of 30 days assessed up to 1 year.
Hospital lengths of stay
Time frame: For the duration of Hospital stay, expected for an average of 30 days assessed up to 1 year.
Mechanical ventilation duration
Time frame: For the duration of ICU and Hospital stay, expected for an average of 30 days
Vasopressor duration in ICU
Time frame: For the duration of ICU and Hospital stay, expected for an average of 30 days
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 18 Dec 2017.
- Derived from this study: PubMed 29452598Daneman N, Rishu AH, Pinto R, Aslanian P, Bagshaw SM, Carignan A, Charbonney E, Coburn B, Cook DJ, Detsky ME, Dodek P, Hall R, Kumar A, Lamontagne F, Lauzier F, Marshall JC, Martin CM, McIntyre L, Muscedere J, Reynolds S, Sligl W, Stelfox HT, Wilcox ME, Fowler RA; Canadian Critical Care Trials Group. 7 versus 14 days of antibiotic treatment for critically ill patients with bloodstream infection: a pilot randomized clinical trial. Trials. 2018 Feb 17;19(1):111. doi: 10.1186/s13063-018-2474-1.
- Derived from this study: PubMed 25903783Daneman N, Rishu AH, Xiong W, Bagshaw SM, Cook DJ, Dodek P, Hall R, Kumar A, Lamontagne F, Lauzier F, Marshall JC, Martin CM, McIntyre L, Muscedere J, Reynolds S, Stelfox HT, Fowler RA; Canadian Critical Care Trials Group. Bacteremia Antibiotic Length Actually Needed for Clinical Effectiveness (BALANCE): study protocol for a pilot randomized controlled trial. Trials. 2015 Apr 18;16:173. doi: 10.1186/s13063-015-0688-z.
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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.
Nick Daneman, MD principal investigator
Sunnybrook Health Sciences Centre
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 7 days of adequate antibiotic treatment durations and 14 days of adequate antibiotic treatment durations in people with Bacteremia, run by Sunnybrook Health Sciences Centre at 17 sites in Canada.
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 2 inclusion and 10 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 18 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Canada. 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.
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?
Adherence to treatment duration protocol (proportion of treatment courses) (time frame: 15 days). The study lists 2 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 NCT02261506, 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 18 Dec 2017.