Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Preventive ceftriaxone to improve functional health in patients with stroke by preventing infection: a multicentre prospective randomised controlled trial
Acronym
PASS
Study hypothesis
We hypothesise that preventive use of the antibiotic ceftriaxone improves functional health outcome in patients with stroke by preventing infection.
Ethics approval
METC of the Academic Medical Center in Amsterdam pending approval as of 17/03/2010
Study design
Multicentre prospective randomised open-label blinded endpoint trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Stroke, infection
Intervention
Our intervention group will be treated with optimal medical care and ceftriaxone 2000 mg, intravenously, 1 time daily, for 4 days. The control group will receive the optimal medical care without ceftriaxone. The total duration of follow-up is 3 months; the primary outcome will then be assessed in a structured interview by telephone.
Intervention type
Drug
Phase
Phase III
Drug names
Ceftriaxone
Primary outcome measures
Functional health at 3-month follow-up, as assessed by the modified Rankin scale (mRS) dichotomised as a favorable outcome (mRS 0 - 2) or an unfavorable outcome (mRS 3 - 6)
Secondary outcome measures
1. Death rate at discharge and 3 months
2. Infection rate during hospital admission
3. Length of hospital admission
4. Volume of post-stroke care
5. Use of antibiotics during the 3 months follow-up
6. Functional health using the full ordinal scoring range of the mRS
7. Quality adjusted life years (QALYs)
8. Costs
Overall trial start date
01/05/2010
Overall trial end date
01/05/2014
Reason abandoned
Eligibility
Participant inclusion criteria
1. Aged greater than or equal to 18 years, either sex
2. Stroke (ischaemic and haemorrhagic)
3. Any measurable neurological deficit defined as National Institutes of Health Stroke Scale (NIHSS) greater than 1
4. Stroke onset less than 24 hours
5. Admission
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
3200
Participant exclusion criteria
1. Symptoms or signs of infection on admission requiring antibiotic therapy
2. Use of antibiotics less than 24 hours before admission
3. Pregnancy
4. Hypersensitivity for cephalosporin
5. Previous anaphylaxis for penicillin or penicillin-derivates
6. Subarachnoid haemorrhage
Recruitment start date
01/05/2010
Recruitment end date
01/05/2014
Locations
Countries of recruitment
Netherlands
Trial participating centre
Academic Medical Centre
Amsterdam
1100 DE
Netherlands
Sponsor information
Organisation
Academic Medical Centre (AMC) (Netherlands)
Sponsor details
Department of Neurology
Meibergdreef 9
Amsterdam
1105AZ
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Research organisation
Funder name
Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands) (ref: 171002302)
Alternative name(s)
Netherlands Organisation for Health Research and Development
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
Netherlands
Funder name
Netherlands Heart Foundation (Nederlandse Hartstichting) (Netherlands) (ref: CD 300006)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2014 statistical analysis plan in: http://www.ncbi.nlm.nih.gov/pubmed/25269598
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24750904
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25612858
Publication citations
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Results
Westendorp WF, Vermeij JD, van Geloven N, Dippel DW, Dijkgraaf MG, van der Poll T, Prins JM, Spanjaard L, Vermeij FH, Nederkoorn PJ, van de Beek D, Update on the Preventive Antibiotics in Stroke Study (PASS): a randomised controlled phase 3 clinical trial., Trials, 2014, 15, 133, doi: 10.1186/1745-6215-15-133.
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Results
Westendorp WF, Vermeij JD, Zock E, Hooijenga IJ, Kruyt ND, Bosboom HJ, Kwa VI, Weisfelt M, Remmers MJ, ten Houten R, Schreuder AH, Vermeer SE, van Dijk EJ, Dippel DW, Dijkgraaf MG, Spanjaard L, Vermeulen M, van der Poll T, Prins JM, Vermeij FH, Roos YB, Kleyweg RP, Kerkhoff H, Brouwer MC, Zwinderman AH, van de Beek D, Nederkoorn PJ; PASS investigators, The Preventive Antibiotics in Stroke Study (PASS): a pragmatic randomised open-label masked endpoint clinical trial, Lancet, 2015 , 385, 9977, 1519-1526, doi: 10.1016/S0140-6736(14)62456-9.
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Statistical analysis plan.
Westendorp WF, Vermeij JD, Dippel DW, Dijkgraaf MG, van der Poll T, Prins JM, Vermeij FH, Roos YB, Brouwer MC, Zwinderman AH, van de Beek D1, Nederkoorn PJ, Update of the Preventive Antibiotics in Stroke Study (PASS): statistical analysis plan, Trials, 2014, 15, 382, doi: 10.1186/1745-6215-15-382.