Use of co-primary outcomes for trials of antimicrobial stewardship interventions

Gillespie, David; Francis, Nick; Carrol, Enitan D.; Thomas-Jones, Emma; Butler, Christopher Collett; Hood, Kerenza

doi:10.1016/s1473-3099(18)30289-5

Cited by 12 publications

(12 citation statements)

References 10 publications

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“…Of interest, RPCR use for the initial suspected pneumonia episode had a carryover effect, leading to even greater differences in vancomycin/linezolid use for the entire subsequent 28-day study period. Although not a predefined coprimary end point as has been suggested for studies of antibiotic stewardship, 28 all predefined safety parameters showed trends toward better outcomes in the RPCR group. Overall results suggest that early discontinuation of anti-MRSA antibiotics was not only safe but potentially beneficial.…”

Section: Discussionmentioning

confidence: 89%

Rapid Detection of Methicillin-Resistant Staphylococcus aureus in BAL

Paonessa

Shah

Pickens

et al. 2019

Chest

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BACKGROUND: Guidelines recommend empirical vancomycin or linezolid for patients with suspected pneumonia at risk for methicillin-resistant Staphylococcus aureus (MRSA). Unneeded vancomycin or linezolid use may unnecessarily alter host flora and expose patients to toxicity. We therefore sought to determine if rapid testing for MRSA in BAL can safely decrease use of vancomycin or linezolid for suspected MRSA pneumonia. METHODS: Operating characteristics of the assay were initially validated against culture on residual BAL. A prospective, unblinded, randomized clinical trial to assess the effect of antibiotic management made on the basis of rapid diagnostic testing (RDT) compared with usual care was subsequently conducted, with primary outcome of duration of vancomycin or linezolid administration. Secondary end points focused on safety. RESULTS: Sensitivity of RPCR was 95.7%, with a negative likelihood ratio of 0.04 for MRSA. The clinical trial randomized 45 patients: 22 to antibiotic management made on the basis of RDT and 23 to usual care. Duration of vancomycin or linezolid administration was significantly reduced in the intervention group (32 h [interquartile range, 22-48] vs 72 h [interquartile range, 50-113], P < .001). Proportions with complications and length of stay trended lower in the intervention group. Hospital mortality was 13.6% in the intervention group and 39.1% for usual care (95% CI of difference,-3.3 to 50.3, P ¼ .06). Standardized mortality ratio was 0.48 for the intervention group and 1.18 for usual care. CONCLUSIONS: A highly sensitive BAL RDT for MRSA significantly reduced use of vancomycin and linezolid in ventilated patients with suspected pneumonia. Management made on the basis of RDT had no adverse effects, with a trend to lower hospital mortality.

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Section: Discussionmentioning

confidence: 89%

Rapid Detection of Methicillin-Resistant Staphylococcus aureus in BAL

Paonessa

Shah

Pickens

et al. 2019

Chest

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“…The majority of studies focus exclusively on process 238 measures. While it is clearly essential to establish whether an intervention is effective in changing 239 antibiotic use, reporting clinical outcomes is crucial to assess the safety of antimicrobial stewardship 240 interventions [16,17]. The clinical outcomes reported often utilise routinely collected data, which may 241 explain the differences between the community and hospital setting.…”

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confidence: 99%

The quality of studies evaluating antimicrobial stewardship interventions: a systematic review

Schweitzer

Heijl

Werkhoven

et al. 2019

Clinical Microbiology and Infection

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“…Finally, ASPs must take additional steps to monitor the safety of stewardship interventions, especially for critically ill patients. The limited available data suggest that stewardship interventions are generally safe (43); however, safety is not mentioned in many ASP studies (24,44). Likewise, most stewardship studies do not specifically attempt to address concerns that providers might have about implementing an intervention.…”

Section: Optimizing Asp Implementationmentioning

confidence: 99%

Antibiotic Stewardship in the Intensive Care Unit. An Official American Thoracic Society Workshop Report in Collaboration with the AACN, CHEST, CDC, and SCCM

Wunderink¹,

Srinivasan²,

Barie³

et al. 2020

Annals ATS

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Intensive care units (ICUs) are an appropriate focus of antibiotic stewardship program efforts because a large proportion of any hospital's use of parenteral antibiotics, especially broad-spectrum, occurs in the ICU. Given the importance of antibiotic stewardship for critically ill patients and the importance of critical care practitioners as the front line for antibiotic stewardship, a workshop was convened to specifically address barriers to antibiotic stewardship in the ICU and discuss tactics to overcome these. The working definition of antibiotic stewardship is "the right drug at the right time and the right dose for the right bug for the right duration." A major emphasis was that antibiotic stewardship should be a core competency of critical care clinicians. Fear of pathogens that are not covered by empirical antibiotics is a major driver of excessively broad-spectrum therapy in critically ill patients. Better diagnostics and outcome data can address this fear and expand efforts to narrow or shorten therapy. Greater awareness of the substantial adverse effects of antibiotics should be emphasized and is an important counterargument to broad-spectrum therapy in individual low-risk patients. Optimal antibiotic stewardship should not focus solely on reducing antibiotic use or ensuring compliance with guidelines. Instead, it should enhance care both for individual patients (by improving and individualizing their choice of antibiotic) and for the ICU population as a whole. Opportunities for antibiotic stewardship in common ICU infections, including community-and hospitalacquired pneumonia and sepsis, are discussed. Intensivists can partner with antibiotic stewardship programs to address barriers and improve patient care.

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Use of co-primary outcomes for trials of antimicrobial stewardship interventions

Cited by 12 publications

References 10 publications

Rapid Detection of Methicillin-Resistant Staphylococcus aureus in BAL

Rapid Detection of Methicillin-Resistant Staphylococcus aureus in BAL

The quality of studies evaluating antimicrobial stewardship interventions: a systematic review

Antibiotic Stewardship in the Intensive Care Unit. An Official American Thoracic Society Workshop Report in Collaboration with the AACN, CHEST, CDC, and SCCM

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