Bacterial Load Guided Therapy for Severe Bronchiectasis Exacerbations

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Brief Title

Bacterial Load Guided Therapy for Severe Bronchiectasis Exacerbations

Official Title

Bacterial Load Guided Therapy for Severe Exacerbations of Bronchiectasis Requiring IntraVenous Antibiotic Therapy- BLT Br IV Study

Brief 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)).
    

Detailed Description

      We will investigate 90 patients with bronchiectasis who are developing an exacerbation as
      defined by the British Thoracic Society guidelines requiring intravenous antibiotics.

      After being consented, patients will be randomly allocated to one of two arms (computer
      generated). 45 patients will have length of treatment guided by the bacterial load and 45
      patients will have 14 days IV Meropenem.

      Next they will all attend for their baseline visit. Here, they will be asked to provide a 24
      hour sputum collected the day prior to the visit, a spontaneous sample collected within 4
      hours from rising (sample used for sputum colour and microbiological analysis), undergo
      spirometry testing, incremental shuttle walk test, blood sampling (for inflammatory markers
      Erythrocyte Sedimentation Rate, C Reactive Protein, Full Blood Count, procalcitonin), fill
      out a leicester cough questionnaire to assess their cough (LCQ) and a health related quality
      of life questionnaire (St George's respiratory questionnaire, SGRQ).

      All patients will be started on intravenous meropenem 2g, tds (assuming no previous
      documented resistant microbiology results or allergies).

      They will all return on day 7 for a check on their clinical progress. At this time they will
      again provide a 24hour sputum, spontaneous sputum sample and blood samples as documented
      above. Arm one (intervention arm) will have their antibiotics stopped on day 8 if the
      bacterial load is less than 10^6cfu/ml. Arm two will continue intravenous meropenem
      regardless of bacterial count.

      All patients will return again on day 10, they will again provide a 24hour sputum,
      spontaneous sputum sample and blood samples as documented above. Arm one (intervention arm)
      will have their antibiotics stopped on day 11 if the bacterial load is less than 10^6cfu/ml.
      Arm two will continue intravenous meropenem regardless of bacterial count.

      All patients will return on day 14. All above assessments as on baseline will be repeated
      except the LCQ and SGRQ. All antibiotics for all patients will stop after 14 days of
      treatment.

      All patients will return on day 21 where all the above assessments will be repeated. The LCQ
      and SGRQ will be completed on day 21. The date of and time to next exacerbation will be
      recorded at the next routine outpatient appointment.
    

Study Phase

Phase 4

Study Type

Interventional


Primary Outcome

Time to next exacerbation

Secondary Outcome

 Clinical recovery at days 14 and 21

Condition

Bronchiectasis

Intervention

Duration

Study Arms / Comparison Groups

 14 days Duration
Description:  14 days of antibiotics regardless of bacterial load.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

90

Start Date

January 2014

Completion Date

February 1, 2020

Primary Completion Date

February 1, 2020

Eligibility 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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Adam T Hill, MBCHB, MRCP, MD, , 

Location Countries

United Kingdom

Location Countries

United Kingdom

Administrative Informations


NCT ID

NCT02047773

Organization ID

BLTBrIVStudy


Responsible Party

Sponsor

Study Sponsor

University of Edinburgh

Collaborators

 NHS Lothian

Study Sponsor

Adam T Hill, MBCHB, MRCP, MD, Principal Investigator, NHS Lothian


Verification Date

May 2020