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
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
Scientific
Liverpool Heart and Chest Hospital NHS Trust
Thomas Drive
Liverpool
L14 3PE
United Kingdom
Study information
| Study design | Pilot single-centre randomised prospective study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study acronym | READ-ICU |
| Study objectives | 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(s) | To be submitted to the Liverpool Adult Research Ethics Committee - pending as of 21/08/2009 |
| Health condition(s) or problem(s) studied | Healthcare-associated infections/sepsis |
| Intervention | Seven days versus two days of empirical antibiotics. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | |
| 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 study start date | 01/11/2009 |
| Completion date | 30/04/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 60 |
| Key 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. |
| Key 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 |
| Date of first enrolment | 01/11/2009 |
| Date of final enrolment | 30/04/2011 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
L14 3PE
United Kingdom
Sponsor information
Hospital/treatment centre
Thomas Drive
Liverpool
L14 3PE
England
United Kingdom
| Phone | +44 151 2281616 |
|---|---|
| bashir.matata@lhch.nhs.uk | |
| Website | http://www.lhch.nhs.uk |
"ROR" |
https://ror.org/01je02926 |
Funders
Funder type
Government
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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not 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.
