Bacteremia Antibiotic Length Actually Needed for Clinical Effectiveness (BALANCE): Study protocol for a pilot randomized controlled trial

Canadian Critical Care Trials Group

doi:10.1186/s13063-015-0688-z

Bacteremia Antibiotic Length Actually Needed for Clinical Effectiveness (BALANCE): Study protocol for a pilot randomized controlled trial

Canadian Critical Care Trials Group

Medicine

Producción científica: Contribución a una revista › Artículo › revisión exhaustiva

26 Citas (Scopus)

Resumen

Background: Bacteremia is a leading cause of mortality and morbidity in critically ill adults. No previous randomized controlled trials have directly compared shorter versus longer durations of antimicrobial treatment in these patients. Methods/Design: This is a multicenter pilot randomized controlled trial in critically ill patients with bacteremia. Eligible patients will be adults with a positive blood culture with pathogenic bacteria identified while in the intensive care unit. Eligible, consented patients will be randomized to either 7 days or 14 days of adequate antimicrobial treatment for the causative pathogen(s) detected on blood cultures. The diversity of pathogens and treatment regimens precludes blinding of patient and clinicians, but allocation concealment will be extended to day 7 and outcome adjudicators will be blinded. The primary outcome for the main trial will be 90-day mortality. The primary outcome for the pilot trial is feasibility defined by (i) rate of recruitment exceeding 1 patient per site per month and (ii) adherence to treatment duration protocol ≥ 90%. Secondary outcomes include intensive care unit, hospital and 90-day mortality rates, relapse rates of bacteremia, antibiotic-related side effects and adverse events, rates of Clostridium difficile infection, rates of secondary infection or colonization with antimicrobial resistant organisms, ICU and hospital lengths of stay, mechanical ventilation and vasopressor duration in intensive care unit, and procalcitonin levels on the day of randomization, and day 7, 10 and 14 after the index blood culture. Discussion: The BALANCE pilot trial will inform the design and execution of the subsequent BALANCE main trial, which will evaluate shorter versus longer duration treatment for bacteremia in critically ill patients, and thereby provide an evidence basis for treatment duration decisions for these infections.

Idioma original	English
Número de artículo	173
Publicación	Trials
Volumen	16
N.º	1
DOI	https://doi.org/10.1186/s13063-015-0688-z
Estado	Published - abr. 18 2015

Nota bibliográfica

Funding Information:
The study protocol is approved by the Sunnybrook Health Sciences Centre and Kingston General Hospital REBs. Funding has been obtained for this pilot RCT from the Ministry of Health and Long-Term Care Academic Health Sciences Alternative Funding Plan Innovation Fund Award (Ontario, Canada). The case report forms (paper and electronic) have been finalized. Training will be done for all the participating sites through webinar before starting recruitment. The study is registered with randomize.net and randomization of test patients has been successfully achieved. The trial is expected to begin enrolling patients in October 2014. Recruitment of patients will start at Sunnybrook Health Sciences Centre (coordinating center) and then roll out successively to the other sites after obtaining REB approval at the individual sites, and finalizing data sharing agreements. With the planned recruitment, we expect to complete this pilot trial in the summer of 2016 and then enroll further Canadian and International centers for the main BALANCE RCT. If the pilot RCT does not identify a need for any substantive protocol changes, this will be an internal pilot trial, and patients will be rolled into the main trial.

Publisher Copyright:
© Daneman et al.; licensee BioMed Central.

ASJC Scopus Subject Areas

Medicine (miscellaneous)
Pharmacology (medical)

PubMed: MeSH publication types

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

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10.1186/s13063-015-0688-z

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title = "Bacteremia Antibiotic Length Actually Needed for Clinical Effectiveness (BALANCE): Study protocol for a pilot randomized controlled trial",

abstract = "Background: Bacteremia is a leading cause of mortality and morbidity in critically ill adults. No previous randomized controlled trials have directly compared shorter versus longer durations of antimicrobial treatment in these patients. Methods/Design: This is a multicenter pilot randomized controlled trial in critically ill patients with bacteremia. Eligible patients will be adults with a positive blood culture with pathogenic bacteria identified while in the intensive care unit. Eligible, consented patients will be randomized to either 7 days or 14 days of adequate antimicrobial treatment for the causative pathogen(s) detected on blood cultures. The diversity of pathogens and treatment regimens precludes blinding of patient and clinicians, but allocation concealment will be extended to day 7 and outcome adjudicators will be blinded. The primary outcome for the main trial will be 90-day mortality. The primary outcome for the pilot trial is feasibility defined by (i) rate of recruitment exceeding 1 patient per site per month and (ii) adherence to treatment duration protocol ≥ 90%. Secondary outcomes include intensive care unit, hospital and 90-day mortality rates, relapse rates of bacteremia, antibiotic-related side effects and adverse events, rates of Clostridium difficile infection, rates of secondary infection or colonization with antimicrobial resistant organisms, ICU and hospital lengths of stay, mechanical ventilation and vasopressor duration in intensive care unit, and procalcitonin levels on the day of randomization, and day 7, 10 and 14 after the index blood culture. Discussion: The BALANCE pilot trial will inform the design and execution of the subsequent BALANCE main trial, which will evaluate shorter versus longer duration treatment for bacteremia in critically ill patients, and thereby provide an evidence basis for treatment duration decisions for these infections.",

author = "{Canadian Critical Care Trials Group} and Nick Daneman and Rishu, {Asgar H.} and Wei Xiong and Bagshaw, {Sean M.} and Cook, {Deborah J.} and Peter Dodek and Richard Hall and Anand Kumar and Francois Lamontagne and Francois Lauzier and Marshall, {John C.} and Martin, {Claudio M.} and Lauralyn McIntyre and John Muscedere and Steven Reynolds and Stelfox, {Henry T.} and Fowler, {Robert A.}",

note = "Funding Information: The study protocol is approved by the Sunnybrook Health Sciences Centre and Kingston General Hospital REBs. Funding has been obtained for this pilot RCT from the Ministry of Health and Long-Term Care Academic Health Sciences Alternative Funding Plan Innovation Fund Award (Ontario, Canada). The case report forms (paper and electronic) have been finalized. Training will be done for all the participating sites through webinar before starting recruitment. The study is registered with randomize.net and randomization of test patients has been successfully achieved. The trial is expected to begin enrolling patients in October 2014. Recruitment of patients will start at Sunnybrook Health Sciences Centre (coordinating center) and then roll out successively to the other sites after obtaining REB approval at the individual sites, and finalizing data sharing agreements. With the planned recruitment, we expect to complete this pilot trial in the summer of 2016 and then enroll further Canadian and International centers for the main BALANCE RCT. If the pilot RCT does not identify a need for any substantive protocol changes, this will be an internal pilot trial, and patients will be rolled into the main trial. Publisher Copyright: {\textcopyright} Daneman et al.; licensee BioMed Central.",

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AU - Canadian Critical Care Trials Group

AU - Daneman, Nick

AU - Rishu, Asgar H.

AU - Xiong, Wei

AU - Bagshaw, Sean M.

AU - Cook, Deborah J.

AU - Dodek, Peter

AU - Hall, Richard

AU - Kumar, Anand

AU - Lamontagne, Francois

AU - Lauzier, Francois

AU - Marshall, John C.

AU - Martin, Claudio M.

AU - McIntyre, Lauralyn

AU - Muscedere, John

AU - Reynolds, Steven

AU - Stelfox, Henry T.

AU - Fowler, Robert A.

N1 - Funding Information: The study protocol is approved by the Sunnybrook Health Sciences Centre and Kingston General Hospital REBs. Funding has been obtained for this pilot RCT from the Ministry of Health and Long-Term Care Academic Health Sciences Alternative Funding Plan Innovation Fund Award (Ontario, Canada). The case report forms (paper and electronic) have been finalized. Training will be done for all the participating sites through webinar before starting recruitment. The study is registered with randomize.net and randomization of test patients has been successfully achieved. The trial is expected to begin enrolling patients in October 2014. Recruitment of patients will start at Sunnybrook Health Sciences Centre (coordinating center) and then roll out successively to the other sites after obtaining REB approval at the individual sites, and finalizing data sharing agreements. With the planned recruitment, we expect to complete this pilot trial in the summer of 2016 and then enroll further Canadian and International centers for the main BALANCE RCT. If the pilot RCT does not identify a need for any substantive protocol changes, this will be an internal pilot trial, and patients will be rolled into the main trial. Publisher Copyright: © Daneman et al.; licensee BioMed Central.

PY - 2015/4/18

Y1 - 2015/4/18

N2 - Background: Bacteremia is a leading cause of mortality and morbidity in critically ill adults. No previous randomized controlled trials have directly compared shorter versus longer durations of antimicrobial treatment in these patients. Methods/Design: This is a multicenter pilot randomized controlled trial in critically ill patients with bacteremia. Eligible patients will be adults with a positive blood culture with pathogenic bacteria identified while in the intensive care unit. Eligible, consented patients will be randomized to either 7 days or 14 days of adequate antimicrobial treatment for the causative pathogen(s) detected on blood cultures. The diversity of pathogens and treatment regimens precludes blinding of patient and clinicians, but allocation concealment will be extended to day 7 and outcome adjudicators will be blinded. The primary outcome for the main trial will be 90-day mortality. The primary outcome for the pilot trial is feasibility defined by (i) rate of recruitment exceeding 1 patient per site per month and (ii) adherence to treatment duration protocol ≥ 90%. Secondary outcomes include intensive care unit, hospital and 90-day mortality rates, relapse rates of bacteremia, antibiotic-related side effects and adverse events, rates of Clostridium difficile infection, rates of secondary infection or colonization with antimicrobial resistant organisms, ICU and hospital lengths of stay, mechanical ventilation and vasopressor duration in intensive care unit, and procalcitonin levels on the day of randomization, and day 7, 10 and 14 after the index blood culture. Discussion: The BALANCE pilot trial will inform the design and execution of the subsequent BALANCE main trial, which will evaluate shorter versus longer duration treatment for bacteremia in critically ill patients, and thereby provide an evidence basis for treatment duration decisions for these infections.

AB - Background: Bacteremia is a leading cause of mortality and morbidity in critically ill adults. No previous randomized controlled trials have directly compared shorter versus longer durations of antimicrobial treatment in these patients. Methods/Design: This is a multicenter pilot randomized controlled trial in critically ill patients with bacteremia. Eligible patients will be adults with a positive blood culture with pathogenic bacteria identified while in the intensive care unit. Eligible, consented patients will be randomized to either 7 days or 14 days of adequate antimicrobial treatment for the causative pathogen(s) detected on blood cultures. The diversity of pathogens and treatment regimens precludes blinding of patient and clinicians, but allocation concealment will be extended to day 7 and outcome adjudicators will be blinded. The primary outcome for the main trial will be 90-day mortality. The primary outcome for the pilot trial is feasibility defined by (i) rate of recruitment exceeding 1 patient per site per month and (ii) adherence to treatment duration protocol ≥ 90%. Secondary outcomes include intensive care unit, hospital and 90-day mortality rates, relapse rates of bacteremia, antibiotic-related side effects and adverse events, rates of Clostridium difficile infection, rates of secondary infection or colonization with antimicrobial resistant organisms, ICU and hospital lengths of stay, mechanical ventilation and vasopressor duration in intensive care unit, and procalcitonin levels on the day of randomization, and day 7, 10 and 14 after the index blood culture. Discussion: The BALANCE pilot trial will inform the design and execution of the subsequent BALANCE main trial, which will evaluate shorter versus longer duration treatment for bacteremia in critically ill patients, and thereby provide an evidence basis for treatment duration decisions for these infections.

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Bacteremia Antibiotic Length Actually Needed for Clinical Effectiveness (BALANCE): Study protocol for a pilot randomized controlled trial

Resumen

Nota bibliográfica

ASJC Scopus Subject Areas

PubMed: MeSH publication types

Acceder al documento

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