Post Stroke Pneumonia Respiratory
Conditions
Interventions
Consented participants will be allocated to either the treatment arm or usual care in a 1:1 ratio via a web-based interface integrated into the electronic Case Report Form (eCRF).
• Intervention arm:
Sponsors
NHS Greater Glasgow and Clyde
University of Glasgow
Eligibility
Sex/Gender
All
Age
18 Years to 120 Years
Inclusion criteria
Inclusion criteria: 1. Age =18 years 2. Acute stroke (ischaemic stroke or intracerebral haemorrhage [ICH]) within the past 14 days 3. Starting (or within 24 hours of starting) non-macrolide antibiotics for a new diagnosis of PSP 4. Written informed consent from participant or from Next of Kin / designated representative or consultee or Independent Physician if lacks capacity (by phone if required) 5. Women of childbearing potential must have a negative highly sensitive serum (beta-human chorionic gonadotropin [beta-hCG]) or urine test at screening
Exclusion criteria
Exclusion criteria: 1. Requirement for macrolide therapy as usual care 2. Confirmed respiratory viral infection (e.g. COVID-19, influenza) at point of screening 3. Known antibiotic treatment for chest infection or pneumonia within the last two weeks (single doses or less than 3 days of treatment is allowed) 4. Known toxin positive C.difficile infection in the past 12 weeks 5. Contraindications or major cautions to macrolide antibiotic use: 5.1. Known hypersensitivity to clarithromycin, its excipients or other macrolide antibiotics 5.2. Established diagnosis of myasthenia gravis 5.3. Diagnosis of long QT syndrome 5.4. QTc interval >460ms on last ECG before screening 5.5. Known uncorrected hypokalaemia (K+ 3 times ULN or known diagnosis of cirrhosis 5.10. Current use of medicine(s) known to increase risk of QT prolongation that in the opinion of the investigator cannot reasonably be withheld for the duration of study treatment plus 3 days 5.11. Current use of medicine(s) that are contra-indicated in combination with clarithromycin that in the opinion of the investigator cannot reasonably be withheld for the duration of study treatment plus 3 days 6. Women of childbearing potential who are pregnant, breastfeeding or who are unwilling to use appropriate contraception or abstain from sexual intercourse for 3 days (72 hours) after the last dose of clarithromycin 7. Plan for imminent mechanical ventilation 8. End-of-life care 9. Previously randomised into the CLASP study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Functional outcome is measured using the modified Rankin Scale (mRS) at Day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Mortality is measured using all-cause mortality at 90 days 2. Home time is measured using days spent in pre-admission usual place of residence at 90 days 3. Cardiovascular mortality is measured using cardiovascular mortality at 90 days 4. Urgent or unplanned readmissions is measured using non-elective admissions by 90 days 5. Recurrent stroke is measured using stroke at 90 days 6. Major cardiovascular events is measured using major cardiovascular events at 90 days 7. Quality of life is measured using EQ-5D-5L at baseline and 90 days 8. Stroke-related health status is measured using the Stroke Impact Scale (SIS) at 90 days 9. Caregiver burden is measured using the Zarit Caregiver Burden (ZBI-12) interview at 90 days 10. Safety is measured using Clostridioides difficile infection within 90 days and ventricular arrhythmia within 7 days 11. Cost-effectiveness is measured using health and social care resource use at baseline and up to 90 days. | — |
Countries
United Kingdom
Contacts
Public ContactCraig J Smith
Outcome results
None listed