BALANCE on the Wards: A Pilot RCT

NCT02917551 | Completed

• 1 other identifier: 218-2016
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 6

Brief Summary

The burden of bloodstream infections is large and increasing over time. Antibiotic overuse continues to drive increased rates of antimicrobial-resistant pathogens across Canada. However, prospective audits have revealed that 30-50% of antibiotic utilization is unnecessary or inappropriate. If shorter duration therapy is as effective as longer duration therapy for these infections, antimicrobial consumption would be decreased. A pilot trial (approved by the Sunnybrook Research Ethics Board), is underway in critically ill patients at 17 Canadian ICUs. Investigators have successfully demonstrated feasibility with respect to protocol adherence and recruitment rates in the ICU. Investigators now aim to conduct a similar pilot RCT among non-ICU patients admitted to hospital wards with bloodstream infections to determine feasibility and protocol adherence of the same trial protocol.

Conditions

Bacteremia

Keywords

Bacteremia, duration, non-critically ill, non-ICU

Outcome Measures

Primary Outcomes (1)

• Feasibility

  defined by: (a) the adherence to treatment duration protocol (proportion of treatment courses); and (b) the rate of recruitment (enrolled per month). Investigators will consider enrolling patients in hospital wards for the BALANCE main trial 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; and, if recruitment rates of at least 4 patients per 4 weeks is achieved.

  15 days

Secondary Outcomes (8)

• Hospital mortality rates

  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 rates

  recorded as alive or dead at 90 days following index positive blood culture

• Relapse rates of bacteremia

  upto 30 days after adequate antibiotic treatment

• Antibiotic allergy and adverse events

  up to 30 days from start of antibiotic treatment.

• Rates of C. difficile infection in hospital

  Upto 30 days after index blood culture collection date

Study Arms (2)

Shorter duration (7 days)

ACTIVE COMPARATOR

Patients in 7 day arm will receive adequate antibiotics until the end of day 7 only

Other: 7 days of adequate antibiotic treatment

Longer duration (14 days)

ACTIVE COMPARATOR

Patients in 14 day arm will receive adequate antibiotics until the end of day 14 only

Other: 14 days of adequate antibiotic treatment

Interventions

7 days of adequate antibiotic treatment OTHER

Shorter duration (7 days)

14 days of adequate antibiotic treatment OTHER

Longer duration (14 days)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is in the hospital ward and not in the intensive care units at time the blood culture result reported as positive AND
• Patient has a positive blood culture with pathogenic bacteria

You may not qualify if:

• Patient already enrolled in either of the BALANCE trials
• Patient is admitted in the ICU at the time of enrollment
• 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 a prosthetic heart valve or synthetic endovascular graft
• Patient has documented or suspicion of syndrome with well-defined requirement for prolonged treatment:
• i) infective endocarditis; ii) osteomyelitis/septic arthritis; iii) undrainable/undrained abscess; iv) 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.

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (6)

Hamilton General Hospital

Hamilton, Ontario, Canada

Location

Kingston General Hospital

Kingston, Ontario, Canada

Location

The Ottawa Hospital

Ottawa, Ontario, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N3M5, Canada

Location

North York General Hospital

Toronto, Ontario, Canada

Location

St. Joseph's Health Centre

Toronto, Ontario, Canada

Location

Related Publications (1)

• Daneman N, Rishu AH, Pinto R, Arabi Y, Belley-Cote EP, Cirone R, Downing M, Cook DJ, Hall R, McGuinness S, McIntyre L, Muscedere J, Parke R, Reynolds S, Rogers BA, Shehabi Y, Shin P, Whitlock R, Fowler RA; Canadian Critical Care Trials Group. A pilot randomized controlled trial of 7 versus 14 days of antibiotic treatment for bloodstream infection on non-intensive care versus intensive care wards. Trials. 2020 Jan 15;21(1):92. doi: 10.1186/s13063-019-4033-9.

  PMID: 31941546 DERIVED

MeSH Terms

Conditions

Bacteremia

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Nick Daneman, MD

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2016
• First Posted: September 28, 2016
• Study Start: October 10, 2016
• Primary Completion: November 30, 2019
• Study Completion: January 30, 2020
• Last Updated: September 14, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (6)