Evidence map›Paper›PMID 24750904›Full record

Trial reportTrials2014

Update on the Preventive Antibiotics in Stroke Study (PASS): a randomised controlled phase 3 clinical trial.

Willeke F Westendorp, Jan-Dirk Vermeij, Nan van Geloven, Diederik W J Dippel, Marcel G W Dijkgraaf, Tom van der Poll, Jan M Prins, Lodewijk Spanjaard, Frederique H Vermeij, Paul J Nederkoorn and 1 more

Open access · goldAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Trials, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
1.1field-weighted citation impact, top 22% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 6 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 3 institutions in 1 country.

Willeke F Westendorp
Jan-Dirk Vermeij
Nan van Geloven
Diederik W J Dippel
Marcel G W Dijkgraaf
Tom van der Poll
Jan M Prins
Lodewijk Spanjaard
Frederique H Vermeij
Paul J NederkoornDepartment of Neurology, Academic Medical Centre, Amsterdam, The Netherlands. p.j.nederkoorn@amc.uva.nl.
Diederik van de Beek
Academic Medical Center · NLErasmus MC · NLSint Franciscus Gasthuis · NL

Funding

European Research Council 281156
6 · The paper itself

Abstract

backgroundStroke is a leading cause of death worldwide. Infections after stroke occur in 30% of stroke patients and are strongly associated with unfavourable outcome. Preventive antibiotic therapy lowers infection rate in patients after stroke, however, the effect of preventive antibiotic treatment on functional outcome after stroke has not yet been investigated.The Preventive Antibiotics in Stroke Study (PASS) is an ongoing, multicentre, prospective, randomised, open-label, blinded end point trial of preventive antibiotic therapy in acute stroke. Patients are randomly assigned to either ceftriaxone at a dose of 2 g, given every 24 hours intravenously for four-days, in addition to stroke-unit care, or standard stroke-unit care without preventive antibiotic therapy. Aim of the study is to assess whether preventive antibiotic treatment improves functional outcome at three months by preventing infections.

resultsTo date, 2,470 patients have been included in PASS. Median stroke severity of the first 2,133 patients (second interim analysis) is 5 (IQR 3 to 9) on the National Institutes of Health Stroke Scale (NIHSS). Due to the PROBE design, no outcome data are available yet. In the initial trial protocol we proposed a dichotomisation of the mRS as primary analysis of outcome and ordinal regression analysis as secondary analysis of primary outcome, requiring a sample size of 3,200 patients. However, ordinal analysis of outcome data is becoming increasingly more common in acute stroke trials, as it increases statistical power. For PASS, funding is insufficient for inclusion of 3,200 patients with the overall inclusion rate of 15 patients per week. Therefore we change the analysis of our primary outcome from dichotomisation to ordinal regression analysis on the mRS. Power analysis showed that with similar assumptions 2,550 patients are needed using ordinal regression analysis. We expect to complete follow-up in June 2014. A full statistical analysis plan will be submitted for publication before treatment allocation will be unblinded.

conclusionThe data from PASS will establish whether preventive antibiotic therapy in acute stroke improves functional outcome by preventing infection. In this update, we changed our primary outcome analysis from dichotomisation to ordinal regression analysis.

trial registrationCurrent controlled trials; ISRCTN66140176. Date of registration: 6 April 2010.

Indexed as

Research DesignAdministration, IntravenousAnti-Bacterial AgentsBacterial InfectionsCeftriaxoneClinical ProtocolsDisability EvaluationDrug Administration ScheduleHumansPatient SelectionRegression AnalysisSample SizeSeverity of Illness IndexStrokeTime FactorsTreatment OutcomeAnti-Bacterial AgentsCeftriaxone

Identifiers

PMID24750904
PMCPMC4000143
OpenAlexW2136948398

What OpenQuestion holds

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LicenceCC BY
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.