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Preventive Antibiotics in Stroke Study

Preventive ceftriaxone to improve functional health in patients with stroke by preventing infection: a multicentre prospective randomised controlled trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN66140176
Enrollment
3200
Registered
2010-04-06
Start date
2010-05-01
Completion date
Unknown
Last updated
2023-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke, infection Circulatory System Stroke, not specified as haemorrhage or infarction

Interventions

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 ceftr
the primary outcome will then be assessed in a structured interview by telephone.

Sponsors

Academic Medical Centre (AMC) (Netherlands)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

Netherlands

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 19, 2026