Gram-negative BacteremiaBALANCE+NCT05893147
BALANCE+ Vanguard Phase
A study testing De-escalation VS No De-escalation, Oral beta-lactams VS non beta-lactams and Central vascular catheter retention VS Central vascular catheter replacement in people with Gram-negative Bacteremia, run by Sunnybrook Health Sciences Centre at 10 sites in Canada.
Trial summary
The goal of the BALANCE+ clinical trial is to transform random care to randomized care for patients with Gram negative bloodstream infections to inform best treatment approaches and optimize outcomes. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Gram-negative Bacteremia
- What is being tested?
- De-escalation VS No De-escalation, Oral beta-lactams VS non beta-lactams and Central vascular catheter retention VS Central vascular catheter replacement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 10 sitesCanada
- Study dates
- 26 Aug 2023to 10 Aug 2024
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 1. included in BALANCE+ platform
- included in BALANCE+ platform
- initially treated with intravenous antibiotics, but clinical team transitioning patient to oral/enteral antibiotic within 7 days of starting treatment
- included in BALANCE+ platform
- has an indwelling central vascular catheter that was already in place within the 48-hour period before the onset of bloodstream infection (i.e. is not a new catheter placed within 48 hours of the onset of infection)
- included in BALANCE+ platform
Show all 13Show fewer
- positive blood culture with GN bacterium, of the following species
- Serratia spp.
- Morganella spp.
- Providencia spp.
- Proteus spp. other than P.mirabilis
- organism is sensitive to ceftriaxone
- 1. included in BALANCE+ platform
Who cannot join
- receiving an empiric antibiotic regimen at the time of blood culture finalization to which the GN pathogen(s) are not sensitive
- carbapenem-resistance (so that patients will not need to remain on reserve-use agents)
- no de-escalation option due to any or all of
- resistance ii. allergies iii. medical contraindications iv. drug-interaction risk v. other relevant reason
- patients with a suspected or proven polymicrobial source of infection
- BETA-LACTAM VS. NON-BETA-LACTAM ORAL/ENTERAL TREATMENT DOMAIN
Show all 29Show fewer
- enrolled in an arm of another BALANCE+ platform domain which limits the use of oral/enteral therapy
- no-de-escalation arm
- no non-beta-lactam options due to any or all of
- resistance ii. allergies iii. medical contraindications iv. drug-interaction risk v. other relevant reason
- no beta-lactam options due to any or all of
- resistance ii. allergies iii. medical contraindications iv. drug-drug interaction risk v. other relevant reason
- CENTRAL VASCULAR CATHETER REPLACEMENT DOMAIN
- patient has no ongoing need for a central vascular catheter
- patient has definite indication for central vascular catheter removal
- ongoing septic shock with definite/probable line source
- concomitant S. aureus bacteremia
- concomitant candidemia
- local suppurative signs (severe redness, warmth, pain, swelling or fluctuance/collection) necessitating catheter removal, or other clinical evidence of infected line (e.g. imaging/echocardiographic findings)
- definite alternative source of GN BSI
- LOW-RISK AmpC DOMAIN
- severe allergy to beta-lactams (eg, type 4 hypersensitivity reaction or DRESS)
- baseline phenotypic resistance to ceftriaxone
- FOLLOW UP BLOOD CULTURE DOMAIN
- patient already discharged home prior to day 4
- definite indication for repeat blood culture testing
- concomitant Staph. aureus bacteremia
- concomitant Candidemia
- clinical suspicion for infective endocarditis (e.g., presence of prosthetic valve, implantable cardiac device)
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Canada10 sites
Foothills Hospital
Calgary, Alberta
Peter Lougheed Centre
Calgary, Alberta
The Ottawa Hospital
Ottawa, Ontario
Niagara Health System
St. Catharines, Ontario
Eastern Regional Health Authority
St. John's, Newfoundland and Labrador
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N3M5
Michael Garron Hospital
Toronto, Ontario
Mount Sinai Hospital
Toronto, Ontario
North York General Hospital
Toronto, Ontario
University Health Network
Toronto, Ontario
About this study
Official title: BALANCE+: A Platform Trial for Gram Negative Bloodstream Infections
The goal of the BALANCE+ clinical trial is to transform random care to randomized care for patients with Gram negative bloodstream infections to inform best treatment approaches and optimize outcomes.
BALANCE+, a perpetual platform trial, will efficiently answer multiple questions that are important for hospitalized patients with Gram negative bloodstream infections.
Read the detailed description
Bloodstream infections (BSIs) are common and lethal, ranking among the top 7 causes of death, with 600,000 cases and 90,000 deaths per year in North America, and 1.2 Million cases and 150,000 deaths per year in Europe. Despite being a leading cause of death worldwide, bloodstream infections remain understudied. Treatment approaches are complicated by rising rates of antimicrobial resistance and declining new drug development.
BALANCE+ provides a platform upon which to answer multiple pressing cross-cutting questions for patients with Gram negative bloodstream infections, including the concept of de-escalating antibiotic spectrum, optimal transition to oral antibiotics, and the role for routine follow up blood culture testing. The trial will also include a syndrome-specific question of whether to remove or retain a central vascular catheter, and a pathogen-specific question of whether cephalosporins are sufficient for patients with low-risk AmpC organisms. As each question is answered, optimal therapies will be adopted into usual care, and new questions will be introduced into the platform of the trial. The evidence generated by BALANCE+ will improve cure for this vulnerable patient population.
- Conditions
- Gram-negative Bacteremia
- Being tested
- De-escalation VS No De-escalation, Oral beta-lactams VS non beta-lactams, Central vascular catheter retention VS Central vascular catheter replacement, Cephalosporin VS Carbapenem for low risk AmpC organisms, Routine follow-up blood culture VS No routine follow-up blood culture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
De-escalation VS No De-escalationOther
No de-escalation group: continue to receive the same antibiotic that was started initially (as long as it is confirmed to be effective based on the blood culture sensitivity result)
De-escalation group: switched to narrower spectrum antibiotic.
Oral beta-lactams VS non beta-lactamsOther
Beta-lactam antibiotic: This can be ciprofloxacin, moxifloxacin, levofloxacin or trimethoprim-sulfamethoxazole.
Non beta-lactam antibiotic: This can be, but not limited to, amoxicillin, amoxicillin-clavulanate, cephalexin, cefadroxil, or cefixime.
Central vascular catheter retention VS Central vascular catheter replacementOther
Central vascular catheter replacement: the catheter will be changed by the treating team as soon as possible and within a maximum of 72 hours from blood culture finalization
Central vascular catheter retention: the catheter will not be changed and will be retained until it is no longer needed.
Cephalosporin VS Carbapenem for low risk AmpC organismsOther
Cephalosporin (ceftriaxone) at standard doses
Carbapenem (like Meropenem, Ertapenem etc) at standard doses
Routine follow-up blood culture VS No routine follow-up blood cultureOther
Routine follow-up blood culture: routine repeat blood collection 4 days from the index blood collection with positive bacteria.
No follow-up blood culture: no routine repeat blood collection 4 days from the index blood collection with positive bacteria
| Study group | Role | What they receive |
|---|---|---|
| De-escalation VS No De-escalation | Active comparator | Not described Receives: Other: De-escalation VS No De-escalation |
| Oral beta-lactams VS Oral Non-beta-lactams | Active comparator | Not described Receives: Other: Oral beta-lactams VS non beta-lactams |
| Central vascular catheter retention VS Central vascular catheter replacement | Active comparator | Not described Receives: Other: Central vascular catheter retention VS Central vascular catheter replacement |
| Cephalosporin VS Carbapenem for low risk AmpC organisms | Active comparator | Not described Receives: Other: Cephalosporin VS Carbapenem for low risk AmpC organisms |
| Routine follow-up blood culture VS No routine follow-up blood culture | Active comparator | Not described Receives: Other: Routine follow-up blood culture VS No routine follow-up blood culture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate (co-primary outcomes of BALANCE+ vanguard phase)
Recruitment rate will be measured as the number of patients randomized to each study domain, overall, and by individual participating site. Investigators will target a minimum overall recruitment rate of 1 patient/site/month in the de-escalation domain, beta-lactam versus non-beta-lactam stepdown domain, and FUBC domain; and 0.25 patients/site/month in the line replacement domain.
Measured: 1 year
Protocol adherence (co-primary outcomes of BALANCE+ vanguard phase)
Protocol adherence will be calculated differently depending on the domain, but in each case will require adherence to the specific intervention arm and complete follow-up for the primary outcome. Investigators will target ≥90% adherence in each arm of each domain.
Measured: 1 year
De-escalation versus no de-escalation domain
- Patient-centered, ordinal Desirability of Outcome Ranking (DOOR) outcome: (dead at 90 days) < (alive at 90 days with reinfection and readmission) < (alive at 90 days with reinfection or readmission) < (alive at 90 days with neither reinfection nor readmission)
- Tie-breaker within ordinal levels: new antimicrobial resistance (AMR) colonization or infection from routine cultures
Measured: 90 days
Oral beta-lactam versus non beta-lactam domain
- Ordinal DOOR outcome: (dead at 90 days) < (alive at 90 days with reinfection and readmission) < (alive at 90 days with reinfection or readmission) < (alive at 90 days with neither reinfection nor readmission)
- Tie-breaker within ordinal levels: new AMR colonization or infection from routine cultures
Measured: 90 days
Central vascular catheter retention versus replacement domain
- Ordinal DOOR outcome: (dead at 90 days) < (alive at 90 days with reinfection and readmission) < (alive at 90 days with reinfection or readmission) < (alive at 90 days with neither reinfection nor readmission)
- No tie-breaker
Measured: 90 days
Low-risk AmpC domain
- Ordinal DOOR outcome: (dead at 90 days) < (alive at 90 days with reinfection and readmission) < (alive at 90 days with reinfection or readmission) < (alive at 90 days with neither reinfection nor readmission)
- Tie-breaker within ordinal levels: new AMR colonization or infection from routine cultures
Measured: 90 days
Follow-up blood culture domain
- Ordinal DOOR outcome: (dead at 90 days) < (alive at 90 days with reinfection and readmission) < (alive at 90 days with reinfection or readmission) < (alive at 90 days with neither reinfection nor readmission)
- No tie-breaker
Measured: 90 days
Secondary outcomes (7)
90-day mortality
Measured: 90 days
90-day reinfection
Measured: 90 days
90-day all cause readmission
Measured: 90 days
90-day AMR colonization/infection
Measured: 90 days
90-day Clostridioides difficile infection (CDI)
Measured: 90 days
30-day mortality
Measured: 30 days
60-day mortality
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2023
- Study start26 Aug 2023
- Primary completion23 Jul 2024
- Study completion10 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gram-negative BacteremiaStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 72 in the overall platform AND at least 12 in each domain.
- Masking
- None (open label)
- Enrolment
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Nick Daneman, MD, Principal investigator, Sunnybrook Health Sciences CentreRob Fowler, MD, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05893147
- Sponsor's protocol ID
- 4369
- Acronym
- BALANCE+
- Status last verified
- Sep 2024
- First submitted
- 18 May 2023
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Daneman N, Johnstone J, Lee TC, MacFadden DR, McDonald EG, Morpeth SC, Ong SWX, Paterson DL, Pinto RL, Rishu A, Rogers BA, Yahav D, Coburn B, Daley P, Das P, Fiest K, Findlater A, Fralick M, George M, Kandel C, Malavade A, Powis J, Somayaji R, Fowler R; BALANCE+ Investigators, and the Association of Medical Microbiology and Infectious Disease Canada Clinical Research Network and the Canadian Critical Care Trials Group. Assessing the feasibility of a platform trial for Gram negative bloodstream infections: results from the vanguard phase of BALANCE. BMJ Open. 2025 Dec 5;15(12):e101588. doi: 10.1136/bmjopen-2025-101588.
PubMed 41360461
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BALANCE+: A Platform Trial for Gram Negative Bloodstream Infections
- ClinicalTrials.gov ID
- NCT05893147
- Acronym / sponsor ID
- BALANCE+ / 4369
- Conditions
- Gram-negative Bacteremia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 174 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 26 Aug 2023 (actual)
- Primary completion
- 23 Jul 2024 (actual)
- Study completion
- 10 Aug 2024 (actual)
- First posted
- 7 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of the BALANCE+ clinical trial is to transform random care to randomized care for patients with Gram negative bloodstream infections to inform best treatment approaches and optimize outcomes.
BALANCE+, a perpetual platform trial, will efficiently answer multiple questions that are important for hospitalized patients with Gram negative bloodstream infections.
Detailed description
Bloodstream infections (BSIs) are common and lethal, ranking among the top 7 causes of death, with 600,000 cases and 90,000 deaths per year in North America, and 1.2 Million cases and 150,000 deaths per year in Europe. Despite being a leading cause of death worldwide, bloodstream infections remain understudied. Treatment approaches are complicated by rising rates of antimicrobial resistance and declining new drug development.
BALANCE+ provides a platform upon which to answer multiple pressing cross-cutting questions for patients with Gram negative bloodstream infections, including the concept of de-escalating antibiotic spectrum, optimal transition to oral antibiotics, and the role for routine follow up blood culture testing. The trial will also include a syndrome-specific question of whether to remove or retain a central vascular catheter, and a pathogen-specific question of whether cephalosporins are sufficient for patients with low-risk AmpC organisms. As each question is answered, optimal therapies will be adopted into usual care, and new questions will be introduced into the platform of the trial. The evidence generated by BALANCE+ will improve cure for this vulnerable patient population.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- 72 in the overall platform AND at least 12 in each domain.
| Arm | Type | Receives |
|---|---|---|
| De-escalation VS No De-escalation | Active comparator | Other: De-escalation VS No De-escalation |
| Oral beta-lactams VS Oral Non-beta-lactams | Active comparator | Other: Oral beta-lactams VS non beta-lactams |
| Central vascular catheter retention VS Central vascular catheter replacement | Active comparator | Other: Central vascular catheter retention VS Central vascular catheter replacement |
| Cephalosporin VS Carbapenem for low risk AmpC organisms | Active comparator | Other: Cephalosporin VS Carbapenem for low risk AmpC organisms |
| Routine follow-up blood culture VS No routine follow-up blood culture | Active comparator | Other: Routine follow-up blood culture VS No routine follow-up blood culture |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (13 listed)
- 1. included in BALANCE+ platform
- included in BALANCE+ platform
- initially treated with intravenous antibiotics, but clinical team transitioning patient to oral/enteral antibiotic within 7 days of starting treatment
- included in BALANCE+ platform
- has an indwelling central vascular catheter that was already in place within the 48-hour period before the onset of bloodstream infection (i.e. is not a new catheter placed within 48 hours of the onset of infection)
Key exclusion criteria (29 listed)
- receiving an empiric antibiotic regimen at the time of blood culture finalization to which the GN pathogen(s) are not sensitive
- carbapenem-resistance (so that patients will not need to remain on reserve-use agents)
- no de-escalation option due to any or all of
- patients with a suspected or proven polymicrobial source of infection
- BETA-LACTAM VS. NON-BETA-LACTAM ORAL/ENTERAL TREATMENT DOMAIN
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 |
|---|---|---|
| De-escalation VS No De-escalationNo de-escalation group: continue to receive the same antibiotic that was started initially (as long as it is confirmed to be effective based on the blood culture sensitivity result) De-escalation group: switched to narrower spectrum antibiotic. | Other | De-escalation VS No De-escalation |
| Oral beta-lactams VS non beta-lactamsBeta-lactam antibiotic: This can be ciprofloxacin, moxifloxacin, levofloxacin or trimethoprim-sulfamethoxazole. Non beta-lactam antibiotic: This can be, but not limited to, amoxicillin, amoxicillin-clavulanate, cephalexin, cefadroxil, or cefixime. | Other | Oral beta-lactams VS Oral Non-beta-lactams |
| Central vascular catheter retention VS Central vascular catheter replacementCentral vascular catheter replacement: the catheter will be changed by the treating team as soon as possible and within a maximum of 72 hours from blood culture finalization Central vascular catheter retention: the catheter will not be changed and will be retained until it is no longer needed. | Other | Central vascular catheter retention VS Central vascular catheter replacement |
| Cephalosporin VS Carbapenem for low risk AmpC organismsCephalosporin (ceftriaxone) at standard doses Carbapenem (like Meropenem, Ertapenem etc) at standard doses | Other | Cephalosporin VS Carbapenem for low risk AmpC organisms |
| Routine follow-up blood culture VS No routine follow-up blood cultureRoutine follow-up blood culture: routine repeat blood collection 4 days from the index blood collection with positive bacteria. No follow-up blood culture: no routine repeat blood collection 4 days from the index blood collection with positive bacteria | Other | Routine follow-up blood culture VS No routine follow-up blood culture |
Primary outcome
Recruitment rate (co-primary outcomes of BALANCE+ vanguard phase)
Time frame: 1 year
Recruitment rate will be measured as the number of patients randomized to each study domain, overall, and by individual participating site. Investigators will target a minimum overall recruitment rate of 1 patient/site/month in the de-escalation domain, beta-lactam versus non-beta-lactam stepdown domain, and FUBC domain; and 0.25 patients/site/month in the line replacement domain.
Protocol adherence (co-primary outcomes of BALANCE+ vanguard phase)
Time frame: 1 year
Protocol adherence will be calculated differently depending on the domain, but in each case will require adherence to the specific intervention arm and complete follow-up for the primary outcome. Investigators will target ≥90% adherence in each arm of each domain.
De-escalation versus no de-escalation domain
Time frame: 90 days
* Patient-centered, ordinal Desirability of Outcome Ranking (DOOR) outcome: (dead at 90 days) < (alive at 90 days with reinfection and readmission) < (alive at 90 days with reinfection or readmission) < (alive at 90 days with neither reinfection nor readmission) * Tie-breaker within ordinal levels: new antimicrobial resistance (AMR) colonization or infection from routine cultures
Oral beta-lactam versus non beta-lactam domain
Time frame: 90 days
* Ordinal DOOR outcome: (dead at 90 days) < (alive at 90 days with reinfection and readmission) < (alive at 90 days with reinfection or readmission) < (alive at 90 days with neither reinfection nor readmission) * Tie-breaker within ordinal levels: new AMR colonization or infection from routine cultures
Central vascular catheter retention versus replacement domain
Time frame: 90 days
* Ordinal DOOR outcome: (dead at 90 days) < (alive at 90 days with reinfection and readmission) < (alive at 90 days with reinfection or readmission) < (alive at 90 days with neither reinfection nor readmission) * No tie-breaker
Low-risk AmpC domain
Time frame: 90 days
* Ordinal DOOR outcome: (dead at 90 days) < (alive at 90 days with reinfection and readmission) < (alive at 90 days with reinfection or readmission) < (alive at 90 days with neither reinfection nor readmission) * Tie-breaker within ordinal levels: new AMR colonization or infection from routine cultures
Follow-up blood culture domain
Time frame: 90 days
* Ordinal DOOR outcome: (dead at 90 days) < (alive at 90 days with reinfection and readmission) < (alive at 90 days with reinfection or readmission) < (alive at 90 days with neither reinfection nor readmission) * No tie-breaker
7 secondary outcomes
90-day mortality
Time frame: 90 days
90-day reinfection
Time frame: 90 days
90-day all cause readmission
Time frame: 90 days
90-day AMR colonization/infection
Time frame: 90 days
90-day Clostridioides difficile infection (CDI)
Time frame: 90 days
30-day mortality
Time frame: 30 days
60-day mortality
Time frame: 60 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 1 Oct 2024.
- Derived from this study: PubMed 41360461Daneman N, Johnstone J, Lee TC, MacFadden DR, McDonald EG, Morpeth SC, Ong SWX, Paterson DL, Pinto RL, Rishu A, Rogers BA, Yahav D, Coburn B, Daley P, Das P, Fiest K, Findlater A, Fralick M, George M, Kandel C, Malavade A, Powis J, Somayaji R, Fowler R; BALANCE+ Investigators, and the Association of Medical Microbiology and Infectious Disease Canada Clinical Research Network and the Canadian Critical Care Trials Group. Assessing the feasibility of a platform trial for Gram negative bloodstream infections: results from the vanguard phase of BALANCE. BMJ Open. 2025 Dec 5;15(12):e101588. doi: 10.1136/bmjopen-2025-101588.
- Individual participant dataSharing planned: No
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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
Rob Fowler, MD principal investigator
Sunnybrook Health Sciences Centre
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing De-escalation VS No De-escalation, Oral beta-lactams VS non beta-lactams and Central vascular catheter retention VS Central vascular catheter replacement in people with Gram-negative Bacteremia, run by Sunnybrook Health Sciences Centre at 10 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 13 inclusion and 29 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 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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?
Recruitment rate (co-primary outcomes of BALANCE+ vanguard phase) (time frame: 1 year). The study lists 7 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 NCT05893147, which also lists 1 linked publication.
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 1 Oct 2024.