Randomised Empirical Antibiotic Duration in Intensive Care Unit

ISRCTN ISRCTN82694288
DOI https://doi.org/10.1186/ISRCTN82694288
Secondary identifying numbers HTA 08/13/38; Protocol version 2.3
Submission date
21/08/2009
Registration date
26/08/2009
Last edited
07/06/2016
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims
There are major concerns that the intensive care unit (ICU) is one of the main sources of hospital-acquired infections in the NHS. Healthcare-acquired infections are a major cause of hospital complications and deaths. For many patients in the ICU, doctors may suspect that they have an infection on the basis of their clinical judgement. They then are put on a course of treatment with antibiotics for much of their stay. Recent studies are suggesting that prolonged antibiotics treatment in the absence of confirmed positive identification of infecting organisms is counterproductive and instead may cause more harm to the patient. The aim of this study is to investigate whether a reduced course of antibiotics is feasible and safe compared to the usual prolonged antibiotic treatment for ICU infections.

Who can participate?
Patients at least 18 years of age in the ICU and suspected of having an infection.

What does the study involve?
Participants are randomly allocated to receive either seven days or two days of antibiotic treatment. We assess whether a reduced course of antibiotics is safe and as effective at preventing infections, and whether these reduced courses of antibiotics have any effect upon survival and length of stay in the ICU and hospital. We also assess whether a larger study is justified in order to address the cost to the NHS if the reduced antibiotics strategy is adopted.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
Liverpool Heart and Chest Hospital NHS Trust (UK)

When is the study starting and how long is it expected to run for?
November 2009 to April 2011

Who is funding the study?
Health Technology Assessment Programme (UK)

Who is the main contact?
Dr Nigel Scawn

Contact information

Dr Nigel Scawn
Scientific

Liverpool Heart and Chest Hospital NHS Trust
Thomas Drive
Liverpool
L14 3PE
United Kingdom

Study information

Study designPilot single-centre randomised prospective study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleA 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
Study acronymREAD-ICU
Study objectivesWe 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

More details can be found at: http://www.nets.nihr.ac.uk/projects/hta/081338
Protocol can be found at: http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0005/52196/PRO-08-13-38.pdf
Ethics approval(s)To be submitted to the Liverpool Adult Research Ethics Committee - pending as of 21/08/2009
Health condition(s) or problem(s) studiedHealthcare-associated infections/sepsis
InterventionSeven days versus two days of empirical antibiotics.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)
Primary outcome measureThe 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 measures1. 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.
Overall study start date01/11/2009
Completion date30/04/2011

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants60
Key inclusion criteriaPatients 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.
Key exclusion criteria1. 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
Date of first enrolment01/11/2009
Date of final enrolment30/04/2011

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Liverpool Heart and Chest Hospital NHS Trust
Liverpool
L14 3PE
United Kingdom

Sponsor information

Liverpool Heart and Chest Hospital NHS Trust (UK)
Hospital/treatment centre

Thomas Drive
Liverpool
L14 3PE
England
United Kingdom

Phone +44 151 2281616
Email bashir.matata@lhch.nhs.uk
Website http://www.lhch.nhs.uk
ROR logo "ROR" https://ror.org/01je02926

Funders

Funder type

Government

Health Technology Assessment Programme
Government organisation / National government
Alternative name(s)
NIHR Health Technology Assessment Programme, HTA
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/09/2012 Yes No

Editorial Notes

07/06/2016: Plain English summary added.