Plain English Summary
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
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HTA 08/13/38; Protocol version 2.3
Study information
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
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
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
To be submitted to the Liverpool Adult Research Ethics Committee - pending as of 21/08/2009
Study design
Pilot single-centre randomised prospective study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Healthcare-associated infections/sepsis
Intervention
Seven days versus two days of empirical antibiotics.
Intervention type
Drug
Phase
Not Applicable
Drug names
Primary outcome measure
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 measures
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.
Overall trial start date
01/11/2009
Overall trial end date
30/04/2011
Reason abandoned (if study stopped)
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
60
Participant 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
Recruitment start date
01/11/2009
Recruitment end date
30/04/2011
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Liverpool Heart and Chest Hospital NHS Trust
Liverpool
L14 3PE
United Kingdom
Sponsor information
Organisation
Liverpool Heart and Chest Hospital NHS Trust (UK)
Sponsor details
Thomas Drive
Liverpool
L14 3PE
United Kingdom
+44 151 2281616
bashir.matata@lhch.nhs.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Health Technology Assessment Programme
Alternative name(s)
NIHR Health Technology Assessment Programme, HTA
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2012 results in http://www.ncbi.nlm.nih.gov/pubmed/23010339
Publication citations
-
Results
Scawn N, Saul D, Pathak D, Matata B, Kemp I, Stables R, Lane S, Haycox A, Houten R, A pilot randomised controlled trial in intensive care patients comparing 7 days' treatment with empirical antibiotics with 2 days' treatment for hospital-acquired infection of unknown origin., Health Technol Assess, 2012, 16, 36, i-xiii, 1-70, doi: 10.3310/hta16360.