Bronchiectasis Respiratory
Conditions
Interventions
Study treatment: Half the study population, at random, will receive 7 days of open labelled intravenous antibiotics and the other half will receive 14 days of open labelled intravenous antibiotics.
Sponsors
University of Edinburgh
NHS Lothian
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults (age 16 or over) 2. Provision of informed consent (from participant or when lacking capacity due to bronchiectasis severity, by their legal representative) 3. A clinical diagnosis of bronchiectasis made by a respiratory specialist supported by CT scan or equivalent clinical confirmation of bronchiectasis 4. Exacerbation where intravenous antibiotics are deemed clinically appropriate 5. Ability to adhere to the study assessments/protocol in the opinion of the Investigator
Exclusion criteria
Exclusion criteria: 1. Patients who are asymptomatic at start of IV antibiotics 2. Known Homozygous Cystic fibrosis 3. Known active tuberculosis 4. Breast feeding, pregnancy, or plan to become pregnant within study 5. End of life care with anticipated life span less than 6 months 6. Current enrolment in a CTIMP where co-enrolment has not been approved 7. Previous recruitment to the SBIVA trial 8. Allergy to Meropenem and protocol permitted alternatives 9. Where trial enrolment is not in the best interest of the patient in the opinion of the Investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time elapsed between starting intravenous antibiotic therapy, until needing another antibiotic course for a protocol-defined exacerbation of bronchiectasis (up to 1 year post randomisation). The following internationally agreed consensus definition of a bronchiectasis exacerbation for clinical trials will be used: Deterioration in three or more of the following key symptoms for at least 48 h: 1. Cough 2. Sputum volume and/or consistency 3. Sputum purulence 4. Breathlessness and/or exercise tolerance 5. Fatigue and/or malaise 6. Haemoptysis 7. A clinician determines antibiotic treatment is required (either oral or intravenous) Exacerbations will be confirmed within 7 days by a clinical member of the research team contacting the participant and reviewing their symptoms. The team member verifying the exacerbation may be an appropriately qualified doctor, nurse or allied health care professional who has been delegated this task by the PI on the site delegation log. Participants will be asked to contact their local research team as soon as possible at the onset of an exacerbation, or on a Monday if an exacerbation starts on a weekend. Participants will be given a study card to remind them of this along with contact details for their local research team. They will also be reminded at each monthly follow-up call. If the verifying person deems the exacerbation does not meet the agreed criteria, the participant will continue in the study until they feel they have another exacerbation. At this point they will then be checked again as described above. This will continue until the participant meets the primary outcome measure (up to one year). All further exacerbations will be recorded but not verified. These conversations will be documented in the patient medical records and exacerbation data entered into the eCRF. | — |
Secondary
| Measure | Time frame |
|---|---|
| The following secondary outcomes will be assessed comparing 7 versus 14 days intravenous antibiotics: 1. St. George’s Respiratory Questionnaire score at baseline and day 14 2. Bronchiectasis Health Questionnaire at baseline and day 14 3. CAT Questionnaire at baseline and day 14 4. Sputum colour at baseline, day 14 and at next exacerbation 5. Adverse events recorded at day 14, month 1 and day 60 6. Sputum pathogen and drug resistance patterns following treatment from samples collected at baseline, day 14 and at the time of next verified exacerbation (up to 1 year post randomisation) 7. Health Economic analysis measured using EQ-5D-5L and Health Care Resource Use questionnaires at baseline, day 14 and at each monthly telephone follow-up (up to 1 year post randomisation) and Cost per Quality Adjusted Life Year (QALY) from a UK National Health Service and Personal Social Services perspective, as simulated via decision analytic modelling over 1, 3, and 5-year time horizons 8. Adherence with allocated intravenous antibiotic intervention having greater than or equal to four sevenths of days of treatment, assessed by diary card and routine prescribing data at day 14 visit | — |
Countries
Scotland, United Kingdom
Contacts
Public ContactPublic Contact
Outcome results
None listed