Condition category
Infections and Infestations
Date applied
21/08/2009
Date assigned
26/08/2009
Last edited
07/06/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Dr Nigel Scawn

ORCID ID

Contact details

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

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 measures

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

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

http://www.lhch.nhs.uk

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

Results - basic reporting

Publication summary

2012 results in http://www.ncbi.nlm.nih.gov/pubmed/23010339

Publication citations

  1. 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.

Additional files

Editorial Notes

07/06/2016: Plain English summary added.