Prophylactic antibiotics after acute stroke for reducing pneumonia in patients with dysphagia (STROKE-INF): a prospective, cluster-randomised, open-label, masked endpoint, controlled clinical trial

Kalra, Lalit; Irshad, Saddif; Hodsoll, John; Simpson, Matthew C.; Gulliford, Martin; Smithard, David; Patel, Anita; Rebollo‐Mesa, Irene

doi:10.1016/s0140-6736(15)00126-9

Cited by 226 publications

(319 citation statements)

References 19 publications

(13 reference statements)

Supporting

Mentioning

305

Contrasting

Unclassified

Order By: Relevance

“…Thus, in future studies, only severely ill patients who carry the highest risk for infection should be considered as candidates for prophylactic antibiotic treatment. At the same time, however, the STROKE-INF study [2], which included only patients with dysphagia, who are without a doubt at high risk for pulmonary infection, preventive antibiotic therapy did not affect incidence of infection. In this light, it appears questionable whether meta-analyses or subgroup analyses of pooled patient data from the-overall negative-trials would identify a certain subgroup of patients who could be selected for future trials.…”

Section: Discussionmentioning

confidence: 93%

“…The most plausible explanation is that in almost all studies, patients were managed in specialist, stateof-the art stroke units. In this setting, prophylactic antibiotics obviously may not add to existing preventive measures such as general hygiene precautions, early mobilization, positioning, regular suction, swallowing techniques, modified diet, and early initiation of antibiotics in patients with suspected infection [2]. Infections after stroke most likely result from complex interactions of bacterial, chemical, mechanical (e.g., indwelling catheters), and immunological mechanisms that might not be prevented by antibiotics alone [2].…”

Section: Discussionmentioning

confidence: 99%

“…The diagnosis of infection in patients with stroke is not trivial. Algorithm-based diagnosis of infection may lead to markedly different results than physician-diagnosed infection [2]. In particular, diagnosing pneumonia in acute stroke poses challenges, and chest Xrays are of limited use in the early stages of pneumonia.…”

Section: Discussionmentioning

confidence: 99%

“…The latest study on prophylactic antibiotic therapy after stroke was the STROKE-INF trial on prophylactic antibiotics after acute stroke for reducing pneumonia in patients with stroke-associated dysphagia [2]. Patients with dysphagia after stroke have the greatest risk of developing pneumonia.…”

Section: Clinical Studies On Preventive Antibiotic Therapy After Strokementioning

confidence: 99%

“…After several clinical studies performed during the last 10 years have produced negative or inconclusive results, however, the enthusiasm for prophylactic antibiotic therapy in acute stroke has now plummeted considerably. After the negative results of 2 large clinical trials-the STROKE-INF [2] and PASS [3] trials published in 2015-an editorial commentator mused that the concept of preventive antibiotic therapy after stroke may have utterly BPASSed away^ [4].…”

Section: Introductionmentioning

confidence: 99%

See 4 more Smart Citations

Prophylactic Antibiotic Therapy for Preventing Poststroke Infection

Schwarz

2016

Neurotherapeutics

View full text Add to dashboard Cite

Infections, in particular pneumonia, are common complications in patients with acute stroke and are associated with a less favorable neurologic and functional outcome. Patients with severe stroke and dysphagia are at highest risk of infection. Experimental and clinical data suggest stroke-induced immunodeficiency as a major factor contributing to the high incidence of infection after stroke. Preclinical studies support the potential benefit of preventive antibiotic therapy in acute stroke for lowering the incidence of infection and improving clinical outcome. Several smaller clinical trials on preventive antibiotic therapy in patients with stroke conducted during the last 10 years yielded inconclusive results. Recently, 2 large, open-label, controlled trials failed to demonstrate an improved clinical outcome after preventive antibiotic therapy in patients with acute stroke treated in specialized stroke units. In the BPreventive Antibiotics in Stroke Study^, antibiotic therapy lowered the rate of infection but did not influence outcome. In the STROKE-INF study, performed in patients with dysphagia after stroke, antibiotic therapy did not lower the incidence of pneumonia and had no prognostic significance. At present, preventive antibiotic therapy cannot be recommended as a therapeutic option for acute stroke.

show abstract

Section: Discussionmentioning

confidence: 93%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Clinical Studies On Preventive Antibiotic Therapy After Strokementioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 3 more Smart Citations

Prophylactic Antibiotic Therapy for Preventing Poststroke Infection

Schwarz

2016

Neurotherapeutics

View full text Add to dashboard Cite

show abstract

Sex Disparities in Enrollment in Recent Randomized Clinical Trials of Acute Stroke

et al. 2021

View full text Add to dashboard Cite

IMPORTANCEThe underenrollment of women in randomized clinical trials represents a threat to the validity of the evidence supporting clinical guidelines and potential disparities in access to novel treatments. OBJECTIVE To determine whether women were underenrolled in contemporary randomized clinical trials of acute stroke therapies published in 9 major journals after accounting for their representation in underlying stroke populations.DATA SOURCES MEDLINE was searched for acute stroke therapeutic trials published between January 1, 2010, and June 11, 2020.STUDY SELECTION Eligible articles reported the results of a phase 2 or 3 randomized clinical trial that enrolled patients with stroke and/or transient ischemic attack and examined a therapeutic intervention initiated within 1 month of onset.DATA EXTRACTION Data extraction was performed by 2 independent authors in duplicate. Individual trials were matched to estimates of the proportion of women in underlying stroke populations using the Global Burden of Disease database. MAIN OUTCOMES AND MEASURESThe primary outcome was the enrollment disparity difference (EDD), the absolute difference between the proportion of trial participants who were women and the proportion of strokes in the underlying disease populations that occurred in women. Random-effects meta-analyses of the EDD were performed, and multivariable metaregression was used to explore the associations of trial eligibility criteria with disparity estimates. RESULTSThe search returned 1529 results, and 115 trials (7.5%) met inclusion criteria. Of 121 105 randomized patients for whom sex was reported, 52 522 (43.4%) were women. The random-effects summary EDD was −0.053 (95% CI, −0.065 to −0.040), indicating that women were underenrolled by 5.3 percentage points. This disparity persisted across virtually all geographic regions, intervention types, and stroke types, apart from subarachnoid hemorrhage (0.117 [95% CI, 0.084 to 0.150]). When subarachnoid hemorrhage trials were excluded, the summary EDD was −0.067 (95% CI, −0.078 to −0.057). In the multivariable metaregression analysis, an upper age limit of 80 years as an eligibility criterion was associated with a 6-percentage point decrease in the enrollment of women.CONCLUSIONS AND RELEVANCE Further research is needed to understand the causes of the underenrollment of women in acute stroke trials. However, to maximize representation, investigators should avoid imposing age limits on enrollment.

show abstract

Antibiotic therapy for preventing infections in people with acute stroke

Vermeij

Westendorp

Dippel

et al. 2018

Cochrane Database of Systematic Reviews

View full text Add to dashboard Cite

Rate of serious adverse eventsNo major side effects of preventive antibiotic therapy were reported. *The absolute risk is calculated using the absolute numbers of events in both study arms. CI: confidence interval; RR: risk ratio; UTIs: urinary tract infections. GRADE Working Group grades of evidence. High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate.a Large number of included studies, large number of participants, and small confidence interval (ultimately low risk of bias). Good applicability in clinical practice. b Limited publication bias cannot be excluded, as funnel plots for primary outcomes were skewed at the base, towards good outcomes.c Regarding risk of bias of individual included studies, more than two of the included studies scored at least one criterion of 'unclear' and/or 'high' risk of bias on the Cochrane 'Risk of bias' summary (Figure 1). However, the e ect on primary outcomes was consistent among studies with 'low' risk of bias.d Regarding consistency of e ect, heterogeneity was substantial (I = 79%). However, overall e ect estimates were precise. Stratifying for included studies with 'low risk of bias' resulted in loss of heterogeneity (I = 4%) and did not a ect outcomes. Therefore, we did not downgrade the quality of evidence. e Downgraded owing to multiple remarks on GRADE considerations, despite the fact that all remarks can be explained and rectified.f Regarding consistency of e ect, heterogeneity was moderate (I = 56%). However, overall e ect estimates were precise. Therefore, we did not downgrade the quality of evidence.

show abstract

Prophylactic antibiotics after acute stroke for reducing pneumonia in patients with dysphagia (STROKE-INF): a prospective, cluster-randomised, open-label, masked endpoint, controlled clinical trial

Abstract: UK National Institute for Health Research.

Cited by 226 publications

References 19 publications

Prophylactic Antibiotic Therapy for Preventing Poststroke Infection

Prophylactic Antibiotic Therapy for Preventing Poststroke Infection

Sex Disparities in Enrollment in Recent Randomized Clinical Trials of Acute Stroke

Antibiotic therapy for preventing infections in people with acute stroke

Contact Info

Product

Resources

About