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

ABSTRACT: 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.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.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.The Pilot Trial was registered on 26 September 2014.NCT02261506.

SUBMITTER: Daneman N

PROVIDER: S-EPMC4407544 | biostudies-literature | 2015 Apr

REPOSITORIES: biostudies-literature

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

Daneman Nick N Rishu Asgar H AH Xiong Wei W Bagshaw Sean M SM Cook Deborah J DJ Dodek Peter P Hall Richard R Kumar Anand A Lamontagne Francois F Lauzier Francois F Marshall John C JC Martin Claudio M CM McIntyre Lauralyn L Muscedere John J Reynolds Steven S Stelfox Henry T HT Fowler Robert A RA

Trials 20150418

<h4>Background</h4>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.<h4>Methods/design</h4>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. E ...[more]

PMID: 25903783

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Project description:IntroductionBloodstream infections are a leading cause of mortality and morbidity; the duration of treatment for these infections is understudied.Methods and analysisWe will conduct an international, multicentre randomised clinical trial of shorter (7 days) versus longer (14 days) antibiotic treatment among hospitalised patients with bloodstream infections. The trial will include 3626 patients across 60 hospitals and 6 countries. We will include patients with blood cultures confirming a pathogenic bacterium after hospital admission. Exclusion criteria will include patient factors (severe immunosuppression), infection site factors (endocarditis, osteomyelitis, undrained abscesses, infected prosthetic material) and pathogen factors (Staphylococcus aureus, Staphylococcus lugdunensis, Candida and contaminant organisms). We will leave the selection of specific antibiotics, doses and route of delivery to the discretion of treating physicians; no placebo control will be used given the diversity of pathogens and sources of bacteraemia. The intervention will be assignment of treatment duration to be 7 versus 14 days. We will minimise selection bias via central randomisation with variable block sizes, with concealed allocation until day 7 of adequate antibiotic treatment. The primary outcome is 90-day survival; we will test whether 7 days is non-inferior to 14 days of treatment, with a non-inferiority margin of 4% absolute mortality. Secondary outcomes include hospital and intensive care unit (ICU) mortality, relapse rates of bacteraemia, hospital and ICU length of stay, mechanical ventilation and vasopressor duration, antibiotic-free days, Clostridium difficile infection, antibiotic allergy and adverse events and colonisation/infection with antibiotic-resistant organisms.Ethics and disseminationThe study has been approved by the ethics review board at each participating site. Sunnybrook Health Sciences Centre is the central ethics committee. We will disseminate study results via the Canadian Critical Care Trials Group and other collaborating networks to set the global paradigm for antibiotic treatment duration for non-staphylococcal Gram-positive, Gram-negative and anaerobic bacteraemia, among patients admitted to hospital.Trial registration numberThe BALANCE (Bacteremia Antibiotic Length Actually Needed for Clinical Effectiveness) trial was registered at www.clinicaltrials.gov (registration number: NCT03005145).

Project description:Background:Antenatal care is an important public health priority. Women from socially disadvantaged, and culturally and linguistically diverse groups often have difficulties with accessing antenatal care and report more negative experiences with care. Although group antenatal care has been shown in some settings to be effective for improving women's experiences of care and for improving other maternal as well as newborn health outcomes, these outcomes have not been rigorously assessed in the UK. A pilot trial will be conducted to determine the feasibility of, and optimum methods for, testing the effectiveness of group antenatal care in an NHS setting serving populations with high levels of social deprivation and cultural, linguistic and ethnic diversity. Outcomes will inform the protocol for a future full trial. Methods:This protocol outlines an individual-level randomised controlled external pilot trial with integrated process and economic evaluations. The two trial arms will be group care and standard antenatal care. The trial will involve the recruitment of 72 pregnant women across three maternity services within one large NHS Acute Trust. Baseline, outcomes and economic data will be collected via questionnaires completed by the participants at three time points, with the final scheduled for 4 months postnatal. Routine maternity service data will also be collected for outcomes assessment and economic evaluation purposes. Stakeholder interviews will provide insights into the acceptability of research and intervention processes, including the use of interpreters to support women who do not speak English. Pre-agreed criteria have been selected to guide the decision about whether or not to progress to a full trial. Discussion:This pilot trial will determine if it is appropriate to proceed to a full trial of group antenatal care in this setting. If progression is supported, the pilot will provide authoritative high-quality evidence to inform the design and conduct of a trial in this important area that holds significant potential to influence maternity care, outcomes and experience. Trial registration:ISRCTN ISRCTN66925258. Registered 03 April 2017. Retrospectively registered.

Project description:IntroductionPerturbation-based balance training (PBT) targets the mechanism of falls (eg, slipping, tripping) to specifically train the recovery actions needed to avoid a fall. This task-specific training has shown great promise as an effective and efficient intervention for fall prevention in older adults. However, knowledge about the dose-response relationship of PBT, as well as its feasibility and acceptability in older adults with increased risk of falling is still limited. Thus, the aim of this study is to compare the effectiveness of two different treadmill PBT protocols for improving reactive balance control in fall-prone older adults, and to evaluate the feasibility and acceptability of these protocols.Methods and analysisThe study is designed as a pilot randomised controlled trial with a 6-week intervention and 6-week follow-up period. Thirty-six community-dwelling, fall-prone (Timed Up and Go >12 s, habitual gait speed <1.0 m/s and/or fall history) older adults will be randomised (1:1) to receive six (weeks 1-6) or two treadmill PBT sessions (weeks 1+6) plus four conventional treadmill training sessions (weeks 2-5). Training sessions are conducted 1×/week for 30 min. Each PBT will include 40 perturbations in anterior-posterior and mediolateral directions. Reactive balance after perturbations in standing (Stepping Threshold Test (STT)) and walking (Dynamic Stepping Threshold Test (DSTT)) will be assessed as the primary outcome for effectiveness. Secondary outcomes are spatiotemporal and kinematic parameters collected during STT, DSTT and PBT, maximum perturbation magnitude for each PBT session, static and dynamic balance, physical capacity, physical activity, concerns with falling and executive functions. Feasibility will be assessed via training adherence, drop-out rate, perturbations actually performed and adverse events; and acceptability via self-designed questionnaire and focus groups.Ethics and disseminationThe study has been approved by the Ethics Committee of the Medical Faculty Heidelberg (S-602/2022). Findings will be disseminated through publications in peer-reviewed journals and conference presentations.Trial registration numberDRKS00030805.

Project description:BackgroundStaphylococcus aureus bacteremia (SAB) is frequently encountered in the hospital setting, and current guidelines recommend at least 14 days of antibiotic treatment for SAB in order to minimize risks of secondary deep infections and relapse. However, evidence to support these treatment recommendations remains scarce. Patients with uncomplicated SAB are known to have a low of risk of recurrence and death. Reducing treatment length in uncomplicated SAB would reduce the total consumption of antibiotics, duration of hospital admission, and potentially the risk of adverse events. With SAB7 we seek to determine if 7 days of antibiotic treatment in patients with uncomplicated SAB is non-inferior to 14 days of treatment.Methods/designThe study is designed as a randomized, non-blinded, non-inferiority, multicenter interventional study. Primary measure of outcome will be 90-day survival without clinical or microbiological failure to treatment or relapse. Secondary outcomes include the prevalence of severe adverse effects, in particular secondary infection with Clostridium difficile, all-cause mortality, as well as public health related costs. Patients identified with uncomplicated SAB who have received 7 days of protocol-approved antibiotics will be eligible for inclusion and randomized 1:1 in two parallel arms to either (i) discontinue antibiotic treatment at day 7 or (ii) to continue antibiotic treatment for a total of 14 days. Main exclusion criteria include signs of complicated SAB, such as the presence of secondary deep infections, persistent bacteremia, and implantable devices. Patients are followed for 6 months with clinical examinations, consecutive blood tests, and registration of adverse events. A total of 284 patients are to be included at ten centers across Denmark. The primary endpoint will be tested with a statistical non-inferiority margin of 10 percentage points.DiscussionSAB 7 will determine if 7 days of antibiotic treatment in patients with uncomplicated SAB is sufficient and safe. Results of the study will provide important knowledge on optimized SAB management and could potentially modify the current treatment recommendations.Trial registrationClinicalTrails.gov, H-17027414 . Registered on May 2, 2018. The Danish Medicines Agency (EudraCT), 2017-003529-13. Registered on October 30, 2017.

Project description:IntroductionFalls risk poststroke is highest soon after discharge from rehabilitation. Reactive balance training (RBT) aims to improve control of reactions to prevent falling after a loss of balance. In healthy older adults, a single RBT session can lead to lasting improvements in reactive balance control and prevent falls in daily life. While increasing the dose of RBT does not appear to lead to additional benefit for healthy older adults, stroke survivors, who have more severely impaired balance control, may benefit from a higher RBT dose. Our long-term goal is to determine the optimal dose of RBT in people with subacute stroke. This assessor-blinded pilot randomised controlled trial aims to inform the design of a larger trial to address this long-term goal.Methods and analysisParticipants (n=36) will be attending out-patient stroke rehabilitation, and will be randomly allocated to one of three groups: one, three or six RBT sessions. RBT will replace a portion of participants' regular physiotherapy so that the total physical rehabilitation time will be the same for the three groups. Balance and balance confidence will be assessed at: (1) study enrolment; (2) out-patient rehabilitation discharge; and (3) 6 months postdischarge. Participants will report falls and physical activity for 6 months postdischarge. Pilot data will be used to plan the larger trial (ie, sample size estimate using fall rates, and which groups should be included based on between-group trends in pre-to-post training effect sizes for reactive balance control measures). Pilot data will also be used to assess the feasibility of the larger trial (ie, based on the accrual rate, outcome completion rate and feasibility of prescribing specific training doses).Ethics and disseminationInstitutional research ethics approval has been received. Study participants will receive a lay summary of results. We will also publish our findings in a peer-reviewed journal.Trial registration numberNCT04219696; Pre results.

Project description:The number of falls experienced by people with knee osteoarthritis (OA) is almost double the number experienced by people with no OA. The neuromuscular elements required to arrest a fall are more impaired in people with knee OA compared to their asymptomatic counterparts. Therefore, these elements may need to be incorporated into an exercise intervention to reduce the risk of falling. The aim of this study will be to examine the feasibility, safety and patient satisfaction of a high-speed resistance-training program, with and without balance exercises, in people with knee OA compared to a control group. The effect of these exercise programs on lower-limb muscle strength and physiological and functional risk factors for falls will also be examined.This study will be a pilot randomized controlled trial with a pre- and post-intervention design (outcome assessments at baseline and 8 weeks after participation commencement) comparing three groups: a control group (no intervention), a high-speed resistance-training group and a high-speed resistance-training plus balance exercises group. Thirty people with knee osteoarthritis aged 60-90 years will be recruited and randomized to one of the three groups. Feasibility and safety will be assessed by examining adherence to the exercise program, dropout rate, pain level during and following exercise, number of exercises stopped due to pain, and any adverse event or any incident that prevents the participant from completing the prescribed exercise. Secondary measures of lower-limb strength, physical function, self-reported pain and function, fear of falls, and executive function and quality of life will also be assessed. To determine statistical trends of effectiveness and hence to inform sample size for a fully powered study, analyses of the secondary outcomes will be performed to assess the changes within and between groups over time (pre-post) using repeated measure ANOVA.The results of this study will improve understanding of what type of exercise is safe and beneficial for people with knee OA to reduce their risk of falling, and hence will inform the development of a future large research trial.Australian New Zealand Clinical Trials Registry, ID: ACTRN12616001382460 . Registered on 6 October 2016.

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

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

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