Condition category
Circulatory System
Date applied
17/03/2010
Date assigned
06/04/2010
Last edited
29/05/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Diederik van de Beek

ORCID ID

Contact details

Department of Neurology
Academic Medical Centre
Meibergdreef 9
Amsterdam
1100 DE
Netherlands

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

http://www.amc.uva.nl/

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

  1. 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.

  2. 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.

  3. 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.

Additional files

Editorial Notes