MINIRES

• Research type

  Research Study

• Full title

  Minimising the risks of emergence of antibiotic resistance during therapy by precise regimen individualisation and use of combination therapy

• IRAS ID

  259350

• Contact name

  Alasdair MacGowan

• Contact email

  Alasdair.Macgowan@nbt.nhs.uk

• Sponsor organisation

  North Bristol NHS Trust

• Eudract number

  2019-003166-40

• Duration of Study in the UK

  2 years, 11 months, 31 days

• Research summary

  Summary of Research
  The study has been designed to establish the feasibility of conducting a larger scale randomised controlled trial to determine whether a combination of both antibiotic dose individualisation and combination antimicrobial therapy are clinically effective in reducing the risks of bacterial resistance and improving clinical outcomes. This study will be using tazobactam-piperacillin (Tazocin) and cidomicin (Gentamicin) as the investigational medicinal products.

  Resistance to antimicrobial drugs (antibiotics) has been identified in the UK, European Union and many other countries as an important problem which, if not addressed, will have a major effect on how patients will be looked after in the future.

  The study will recruit patients who have been admitted to the ICU and have been on a ventilator for five or more days, with suspected pulmonary infection. The study excludes patients under the age of 18, patients with specific co-morbidities, pregnant women and prisoners.

  There are two sites planned to be opened, both with previous experience in the study area. The study will be open to recruitment for 2 years, and aims to recruit 80 patients.

  The patients on study will be on one of 4 arms:
  Arm A: Standard Care Piperacillin-Tazobactam
  Arm B: Standard Care Piperacillin-Tazobactam & Gentamicin
  Arm C: Drug Personalised Piperacillin-Tazobactam
  Arm D: Drug Personalised Piperacillin-Tazobactam & Gentamicin

  All patients on study will have additional tests (above standard of care): stool sample & extubation sample.

  Patients on Arms C & D will have additional blood draws for analysis for personalised dosing

  Summary of Research
  The study did not open to recruitment and therefore gathered no results

• REC name

  North West - Greater Manchester South Research Ethics Committee

• REC reference

  20/NW/0041

• Date of REC Opinion

  11 Jan 2021

• REC opinion

  Further Information Favourable Opinion