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RECRUITING
NCT06537609
NA

A Platform Trial for Gram Negative Bloodstream Infections

Sponsor: Sunnybrook Health Sciences Centre

View on ClinicalTrials.gov

Summary

BALANCE+ is a perpetual multiple domain randomized controlled platform trial to evaluate various treatment strategies for Gram-negative bloodstream infections (GN BSIs). Each domain addresses critical questions in the management of GN BSIs, aiming to refine treatment strategies, enhance patient outcomes, and reduce antimicrobial resistance. The initial vanguard pilot RCT (NCT05893147) started on 29 August 2023 and has successfully completed the pilot phase on 24-Apr-2024. All patients enrolled in the vanguard phase are part of the main platform trial.

Official title: BALANCE+: A Platform Trial for Gram Negative Bloodstream Infections

Key Details

Gender

All

Age Range

0 Years - 130 Years

Study Type

INTERVENTIONAL

Enrollment

2500

Start Date

2024-04-24

Completion Date

2028-04

Last Updated

2026-02-10

Healthy Volunteers

No

Interventions

OTHER

De-escalation VS No De-escalation

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 is only allowed within 7 days if patient is being discharged from hospital. De-escalation group: switched to narrower spectrum antibiotic (based on spectrum scale specified in protocol).

OTHER

Oral beta-lactams VS non beta-lactams

Beta-lactam antibiotic: This can be, but not limited to, amoxicillin, amoxicillin-clavulanate, cephalexin, cefadroxil, or cefixime. Non beta-lactam antibiotic: This can be ciprofloxacin, moxifloxacin, levofloxacin or trimethoprim-sulfamethoxazole.

OTHER

Central vascular catheter retention VS Central vascular catheter replacement

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 non functional or no longer needed.

OTHER

Cephalosporin VS Carbapenem for low risk AmpC organisms

Cephalosporin (ceftriaxone) at standard doses Carbapenem (Meropenem or Ertapenem) at standard doses

OTHER

Routine follow-up blood culture VS No routine follow-up blood culture

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

Locations (39)

St George Hospital

Kogarah, New South Wales, Australia

John Hunter Hospital

New Lambton, New South Wales, Australia

Royal Brisbane and Women's Hospital

Herston, Queensland, Australia

Redcliffe Hospital

Redcliffe, Queensland, Australia

Sunshine Coast University Hospital

Sunshine Coast, Queensland, Australia

Monash Medical Center

Clayton, Victoria, Australia

Fiona Stanley Hospital

Murdoch, Western Australia, Australia

St John of God

Murdoch, Western Australia, Australia

Foothills Hospital

Calgary, Alberta, Canada

Peter Lougheed Centre

Calgary, Alberta, Canada

Rockyview General Hospital

Calgary, Alberta, Canada

South Health Campus

Calgary, Alberta, Canada

University of Alberta

Edmonton, Alberta, Canada

Surrey Memorial Hospital

Surrey, British Columbia, Canada

Vancouver General Hospital

Vancouver, British Columbia, Canada

Grace Hospital

Winnipeg, Manitoba, Canada

Health Sciences Centre

Winnipeg, Manitoba, Canada

St. Boniface Hospital

Winnipeg, Manitoba, Canada

Dr. Everett Chalmers Regional Hospital

Fredericton, New Brunswick, Canada

Eastern Regional Health Authority

St. John's, Newfoundland and Labrador, Canada

Trillium Health Partners - Mississauga Hospital

Mississauga, Ontario, Canada

Humber River Health system

North York, Ontario, Canada

North York General Hospital

North York, Ontario, Canada

The Ottawa Hospital

Ottawa, Ontario, Canada

Niagara Health System

St. Catharines, Ontario, Canada

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Michael Garron Hospital

Toronto, Ontario, Canada

Mount Sinai Hospital

Toronto, Ontario, Canada

St. Joseph's Health Centre

Toronto, Ontario, Canada

University Health Network

Toronto, Ontario, Canada

CHU de Québec - Université Laval

Laval, Quebec, Canada

Hôpital de la Cité de la Santé

Laval, Quebec, Canada

Montreal General Hospital- McGill

Montreal, Quebec, Canada

Royal Victoria Hospital- McGill

Montreal, Quebec, Canada

Université de Sherbrooke

Sherbrooke, Quebec, Canada

Centre hospitalier affilié universitaire régional (CHAUR)

Trois-Rivières, Quebec, Canada

Universidad de La Sabana

Chía, Cundinamarca, Colombia

Sheba Medical Center

Ramat Gan, Tel Aviv, Israel

Middlemore Hospital

Auckland, Auckland, New Zealand