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Randomised Empirical Antibiotic Duration in Intensive Care Unit
ISRCTN ISRCTN82694288
DOI 10.1186/ISRCTN82694288
ClinicalTrials.gov identifier
EudraCT number
Public title Randomised Empirical Antibiotic Duration in Intensive Care Unit
Scientific title A pilot randomised controlled trial comparing seven days versus two days of empirical antibiotics to treat hospital acquired infection of unknown origin in intensive care patients
Acronym READ-ICU Trial
Serial number at source HTA 08/13/38; Protocol version 2.3
Study hypothesis We hypothesise that reduced duration of empirical antibiotics use in the intensive care unit (ICU) setting is likely to have the following impact on patients and the healthcare service:
1. Reduce overall ICU treatment costs
2. Reduce the risk of patients developing antibiotics resistant organisms e.g. methicillin-resistant Staphylococcus aureus (MRSA)
3. Reduce the risk of patients acquiring other infections e.g. Clostridium difficile
4. Reduce exposure of patients to unnecessary treatment likely to increase risk of allergic reactions
Lay summary Not provided at time of registration
Ethics approval To be submitted to the Liverpool Adult Research Ethics Committee as of 21 August 2009.
Study design Pilot single-centre randomised prospective study
Countries of recruitment United Kingdom
Disease/condition/study domain Healthcare associated infections/sepsis
Participants - inclusion criteria Patients in the intensive care unit suspected of having infection of unknown origin will be eligible for inclusion if they are:
1. Both males and females, at least 18 years of age
2. Assent given by relatives/legal representative and written consent reaffirmed once the patient gets better. If patient is able to give informed consent this has to be given in writing.
Participants - exclusion criteria 1. Positive blood cultures pre-randomisation
2. Patients currently enrolled in any other study where involvement in this pilot study would risk deviation from either protocols
3. Allergy to treatment antibiotics
Anticipated start date 01/11/2009
Anticipated end date 30/04/2011
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 60
Interventions Seven days versus two days of empirical antibiotics.
Primary outcome measure(s) The rate of death or initiation of antibiotic therapy after the completion of the treatment schedule allocated at randomisation.

All outcome measures will be assessed at day 10 or at hospital discharge, whichever is sooner.
Secondary outcome measure(s) 1. Clinical
1.1. Duration of ICU stay
1.2. Duration of Hospital stay
1.3. Duration of mechanical ventilation
1.4. Incidence of infection with clostridium difficile
1.5. Incidence of infection with MRSA

2. Economic
2.1. Resource utilisation and costs

3. Feasibility outcomes
3.1. The ratio of patients - screened : eligible : randomised
3.2. The incidence of cross-over between the randomised treatment groups
3.3. The accuracy of data collection assessed by a 20% source data verification check

All outcome measures will be assessed at day 10 or at hospital discharge, whichever is sooner.
Sources of funding NIHR Health Technology Assessment Programme - HTA (UK): Healthcare Associated Infection Programme
Trial website
Publications 1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/23010339
Contact name Dr  Nigel  Scawn
  Address Liverpool Heart and Chest Hospital NHS Trust
Thomas Drive
  City/town Liverpool
  Zip/Postcode L14 3PE
  Country United Kingdom
Sponsor Liverpool Heart and Chest Hospital NHS Trust (UK)
  Address Thomas Drive
  City/town Liverpool
  Zip/Postcode L14 3PE
  Country United Kingdom
  Tel +44 151 2281616
  Fax +44 151 6001862
  Email bashir.matata@lhch.nhs.uk
  Sponsor website: http://www.lhch.nhs.uk
Date applied 21/08/2009
Last edited 28/02/2013
Date ISRCTN assigned 26/08/2009
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