Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

BALANCE on the Wards: A Pilot RCT (BALANCE-Wards)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02917551
Recruitment Status : Recruiting
First Posted : September 28, 2016
Last Update Posted : April 10, 2019
Sponsor:
Information provided by (Responsible Party):
Sunnybrook Health Sciences Centre

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.

Condition or disease Intervention/treatment Phase
Bacteremia Other: 7 days of adequate antibiotic treatment Other: 14 days of adequate antibiotic treatment Not Applicable

Detailed Description:

Bloodstream infections are a common and serious problem, and are associated with increased morbidity and mortality. At the same time, antibiotic overuse is also a common and serious problem, in that 30-50% of antibiotic use is unnecessary or inappropriate, and results in avoidable drug side effects such as kidney failure, Clostridium difficile infection, increased costs, and spiraling antibiotic resistance rates. The greatest contributor to antibiotic overuse is excessive durations of treatment.

Extensive research has demonstrated that shorter duration antibiotic treatment (less or equal to 7 days) is as effective as longer duration treatment for a variety of infectious diseases, but this question has not been directly studied in the setting of bloodstream infection. Our team's systematic review of the medical literature, national survey of Canadian infectious diseases and critical care physicians, and multicentre retrospective study all support the need for a randomized controlled trial comparing shorter (7 days) versus longer (14 days) antibiotic therapy for bloodstream infections.

Prior to performing the main trial, our pilot RCT in critically ill patients is near-completion.

In order to increase the generalizability to non-critically ill patients, Investigators want to conduct a similar pilot RCT in non-critically ill patients (BALANCE on the Wards) to establish the feasibility of the research design, and to optimize the definitive trial.

Investigators will conduct a randomized concealed allocation trial of shorter duration (7 days) versus longer duration (14 days) antibiotic treatment for patients with bloodstream infections across all non-ICU hospital wards in Sunnybrook Hospital (BALANCE on the Wards). Our ongoing BALANCE pilot RCT in ICU is approved by the Sunnybrook REB (PIN: 187-2014). The BALANCE on Wards pilot trial will use the same protocol, informed consent form and the case report forms that are approved by the Sunnybrook REB with minimal changes to make it ward specific. If the investigators are able to achieve the primary outcome of this trial in Sunnybrook hospital, the main BALANCE trial will potentially involve enrolment of non-ICU patients at all (or a subset of) participating sites.

If eligibility criteria and study procedures are substantially unchanged, results of the both the pilot BALANCE RCTs will be rolled into the dataset for the main BALANCE RCT.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Bacteremia Antibiotic Length Actually Needed for Clinical Effectiveness- BALANCE on the Wards: A Pilot RCT
Actual Study Start Date : October 10, 2016
Estimated Primary Completion Date : January 10, 2020
Estimated Study Completion Date : January 20, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arm Intervention/treatment
Active Comparator: Shorter duration (7 days)
Patients in 7 day arm will receive adequate antibiotics until the end of day 7 only
Other: 7 days of adequate antibiotic treatment
Active Comparator: Longer duration (14 days)
Patients in 14 day arm will receive adequate antibiotics until the end of day 14 only
Other: 14 days of adequate antibiotic treatment



Primary Outcome Measures :
  1. Feasibility [ Time Frame: 15 days ]
    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.


Secondary Outcome Measures :
  1. Hospital mortality rates [ 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. ]
  2. 90-day mortality rates [ Time Frame: recorded as alive or dead at 90 days following index positive blood culture ]
  3. Relapse rates of bacteremia [ Time Frame: upto 30 days after adequate antibiotic treatment ]
    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.

  4. Antibiotic allergy and adverse events [ Time Frame: up to 30 days from start of antibiotic treatment. ]
  5. Rates of C. difficile infection in hospital [ Time Frame: Upto 30 days after index blood culture collection date ]
  6. Rates of secondary nosocomial infection with antimicrobial resistant organisms in hospital [ Time Frame: upto 30 days after index blood culture collection date ]
  7. Hospital length of stay [ Time Frame: for the duration of Hospital stay, expected for an average of 30 days assessed up to 1 year ]
  8. Antibiotic free days [ Time Frame: no. of days patient remained without antibiotics for up to 30 days post index blood culture collection date ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Patient already enrolled in either of the BALANCE trials
  2. Patient is admitted in the ICU at the time of enrollment
  3. 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
  4. Patient has a prosthetic heart valve or synthetic endovascular graft
  5. 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

  6. 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.
  7. Patient has a positive blood culture with Staphylococcus aureus.
  8. Patient has a positive blood culture with Candida spp. or other fungal species.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02917551


Contacts
Layout table for location contacts
Contact: Nick Daneman, MD nick.daneman@sunnybrook.ca
Contact: Rob Fowler, MD rob.fowler@sunnybrook.ca

Locations
Layout table for location information
Canada, Ontario
Hamilton General Hospital Recruiting
Hamilton, Ontario, Canada
Contact: Richard Whitlock, MD         
Kingston General Hospital Recruiting
Kingston, Ontario, Canada
Contact: John Muscedere, MD         
The Ottawa Hospital Recruiting
Ottawa, Ontario, Canada
Contact: Lauralyn McIntyre, MD         
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4N3M5
Contact: Nick Daneman, MD    4164806100 ext 2791    nick.daneman@sunnybrook.ca   
Sub-Investigator: Rob A Fowler, MD         
North York General Hospital Recruiting
Toronto, Ontario, Canada
Contact: Phil Shin, MD         
St. Joseph's Health Centre Recruiting
Toronto, Ontario, Canada
Contact: Robert Cirone, MD         
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Investigators
Layout table for investigator information
Principal Investigator: Nick Daneman, MD Sunnybrook Health Sciences Centre

Layout table for additonal information
Responsible Party: Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT02917551     History of Changes
Other Study ID Numbers: 218-2016
First Posted: September 28, 2016    Key Record Dates
Last Update Posted: April 10, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Sunnybrook Health Sciences Centre:
Bacteremia, duration, non-critically ill, non-ICU
Additional relevant MeSH terms:
Layout table for MeSH terms
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
Bacteremia
Bacterial Infections
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes