Bacterial Load Guided Therapy for Severe Bronchiectasis Exacerbations

• Status: Completed
• Trial end date: 2020-02-01
• Target enrollment: 0
• Participant gender: All

Summary

From the British Thoracic Guidelines1 and a PUBMED search there are no randomised controlled trials exploring optimum antibiotic duration for chest infections. The standard course of intravenous antibiotics for exacerbations of bronchiectasis is 14 days. This is a preliminary open labelled study to assess whether it is feasible to stop treatment earlier (day 8 or day 11) if the bacterial load is low or absent at days 7 or day 10 (it takes 24 hours for the results to be processed). All patients will therefore have a minimum of 7 days intravenous antibiotics. The intravenous antibiotic chosen is routinely used for exacerbations in bronchiectasis.

Our hypothesis is that patients could have personalised treatment and be able to stop antibiotics when the sputum bacterial load is low (<10^6 colony forming units/ml (cfu/ml)).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Edinburgh
• Collaborator: NHS Lothian
• Treatments: Anti-Bacterial Agents; Antibiotics, Antitubercular; Meropenem

Criteria

Inclusion Criteria:

• Patients aged 18 and above

• An established primary diagnosis of non cystic fibrosis bronchiectasis

• Patients need to meet the criteria for needing intravenous antibiotic therapy.

• Only the first exacerbation per patient will be used.

Exclusion Criteria:

• Patients with organisms resistant in vitro to Meropenem (this is known from previous sputum microbiology but is rare in our cohort);

• Current smokers or ex-smokers of less than 1 year;

• Cystic fibrosis;

• Active allergic bronchopulmonary aspergillosis;

• Active tuberculosis;

• Poorly controlled asthma necessitating long term oral corticosteroids;

• Pregnancy or breast feeding;

• Active malignancy;

• Severe chronic obstructive pulmonary disease (COPD) on long term oxygen therapy;

• Patients requiring non invasive or invasive ventilation;

• Known allergy to Meropenem which is very rare in our cohort.