Preventive Antibiotics in Stroke Study
| ISRCTN | ISRCTN66140176 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN66140176 |
| Secondary identifying numbers | N/A |
- Submission date
- 17/03/2010
- Registration date
- 06/04/2010
- Last edited
- 29/03/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Diederik van de Beek
Scientific
Scientific
Department of Neurology
Academic Medical Centre
Meibergdreef 9
Amsterdam
1100 DE
Netherlands
Study information
| Study design | Multicentre prospective randomised open-label blinded endpoint trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Preventive ceftriaxone to improve functional health in patients with stroke by preventing infection: a multicentre prospective randomised controlled trial |
| Study acronym | PASS |
| Study objectives | We hypothesise that preventive use of the antibiotic ceftriaxone improves functional health outcome in patients with stroke by preventing infection. |
| Ethics approval(s) | METC of the Academic Medical Center in Amsterdam pending approval as of 17/03/2010 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Ceftriaxone |
| Primary outcome measure | 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 study start date | 01/05/2010 |
| Completion date | 01/05/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 3200 |
| Total final enrolment | 2470 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/05/2010 |
| Date of final enrolment | 01/05/2014 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Academic Medical Centre
Amsterdam
1100 DE
Netherlands
1100 DE
Netherlands
Sponsor information
Academic Medical Centre (AMC) (Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Department of Neurology
Meibergdreef 9
Amsterdam
1105AZ
Netherlands
| Website | http://www.amc.uva.nl/ |
|---|---|
"ROR" |
https://ror.org/03t4gr691 |
Funders
Funder type
Research organisation
Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands) (ref: 171002302)
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- Netherlands Organisation for Health Research and Development
- Location
- Netherlands
Netherlands Heart Foundation (Nederlandse Hartstichting) (Netherlands) (ref: CD 300006)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 21/04/2014 | Yes | No | |
| Statistical Analysis Plan | statistical analysis plan | 01/10/2014 | No | No | |
| Results article | results | 18/04/2015 | Yes | No | |
| Results article | results | 01/07/2018 | 27/08/2019 | Yes | No |
| Results article | results | 01/01/2020 | 15/04/2020 | Yes | No |
| Results article | sub study results | 12/01/2021 | 15/01/2021 | Yes | No |
| Other publications | Association between leukocyte counts and carotid artery stenosis | 08/12/2022 | 28/12/2022 | Yes | No |
| Abstract results | Substudy results abstract European Stroke Organisation Conference 2021 | 03/09/2021 | 29/03/2023 | No | No |
Editorial Notes
29/03/2023: Abstract added.
28/12/2022: Publication reference added.
15/01/2021: Publication reference added.
15/04/2020: Publication reference added.
27/08/2019: Publication reference and total final enrolment added.
