Stroke and stroke-associated infection MedDRA version: 12.1 Level: LLT Classification code 10042244 Term: Stroke MedDRA version: 12.1 Level: LLT Classification code 10021789 Term: Infection
Conditions
Interventions
Trade Name: Ceftriaxone
Product Name: Ceftriaxone
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: CEFTRIAXONE
CAS Number: 73384-59-5
Concentration unit: mg milligram(s)
Conc
Sponsors
AMC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age>18 yr 2. Stroke (ischemic and hemorrhagic) 3. Any measurable neurological deficit defined as NIHSS >1 4. Stroke onset =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Clinical signs of infection on admission requiring antibiotic therapy 2. Use of antibiotics < 24 h before admission 3. Pregnancy 4. Hypersensitivity for cephalosporin 5. Anaphylaxis for penicillin derivates
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate whether prophylactic use of the antibiotic ceftriaxone improves functional health outcomes in patients with stroke by preventing infection. ;Secondary Objective: Within this trial we will also assess the cost-effectiveness of this preventive treatment. ;Primary end point(s): The primary efficacy end point will be functional health at 3-month follow-up, as assessed by the modified Rankin scale (mRS) dichotomized as a favourable outcome (mRS 0-2) or an unfavourable outcome (mRS 3-6).(20) Improvement beyond expectation according to the sliding dichotomy approach is more sensitive to treatment effects, as it takes into account improvements at any point on the mRS. Therefore, this will be our secondary analysis.(24) Beneficial effects in this approach should be accompanied by effects on the classic endpoints in the same direction to be considered convincing. | — |
Countries
Netherlands
Outcome results
None listed