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IC/291/10 Infection Control Precautions for Extended Spectrum Lacatamase Producers (ESBL)

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BASINGSTOKE AND NORTH HAMPSHIRE NHS FOUNDATION TRUST

Infection Control Precautions for Extended Spectrum β− lacatamase producers (ESBL)

IC/291/10

Supersedes: IC/291/07

Owner Name Dr Nicki Hutchinson Job Title Consultant Microbiologist Final approval committee

Name Infection Control Committee

Date of meeting 05/03/2010 Authoriser Name Anne Stebbing Job title Chair, ICC Signature

Date of authorisation 05/03/2010 Review date (maximum 3 years from date

of authorisation) March 2013

Audience (tick all that apply) Trust staff NHS General public

Standards Standards for Better Health & Hygiene code

NHSLA Reviewed in accordance with The Health and Social Care Act 2008: Code of Practice for health and adult social care on the prevention and control of infections and related guidance as published 16 December 2009. Executive Summary This is a protocol that describes the infection control precautions necessary for the surveillance and management of patients infected with ESBL producing Gram negative organisms. It describes the procedures necessary to prevent spread of these infections within Basingstoke and North Hampshire Foundation Trust (BNHFT).

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Implementation Plan Summary of changes This is an updated protocol written to formally describe current practice for ESBL producers control due to rise in these infections recently. Current practice is based on isolation precautions policy under multi drug resistant organisms. Action needed and owner of action

• All clinical staff need to be aware of rise in antibiotic resistance and need for prudent use of antibiotics and infection control precautions. They are responsible for seeking and attending infection control training sessions

• The Infection control team (ICT), microbiologist are responsible for monitoring infections as they arise as well as trends, using lab based ward liaison surveillance, ensuring appropriate precautions are undertaken. They are responsible for updating staff on infection trends with ESBL and isolation precautions required to prevent spread (basic contact precautions).

• Microbiologists and pharmacists are responsible for highlighting links between ESBL infections and antibiotic prescribing, ensuring an up to date antibiotic policy is in place and monitoring antibiotic usage

• Managers should ensure that all necessary equipment for managing patients infected with multi drug resistant organisms is in place. They are responsible for observing trends of such infections in their areas, when reported by the ICT and ensuring control measures are in place

• The Consultants in Communicable Disease Control will be informed by microbiologists if serious infections with ESBL-producing E. coli occur in hospitals or the community.

Audit standard and criteria:

Standard: Patients infected with ESBL are managed according to precautions set out in this policy and no cross infection occurred. (100%)

Audit criteria:

• Number of ESBL infections acquired in hospital • Isolation precautions undertaken for all patients with ESBL producers regardless

to whether they are acquired in hospital or the community • Staff awareness assessment (of nature of infection and precautions required)

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Infection Control Contacts: Dr N Hutchinson Consultant Microbiologist/Infection Control Doctor Ext 3310 Dr F El Bakri Consultant Microbiologist Ext 3305

Hazel Gray Senior Infection Control Sister Ext 6774 or bleep 2364

Linda Swanson Infection Control Sister Ext 6774 or bleep 2364

Bruce Wake Trust Surveillance Co-ordinator Ext 3904

Table of Contents

Page

Number 1.0 Introduction 3 2.0 Local Epidemiology 4 3.0 Clinical Significance of ESBLs 4 4.0 Clinical Presentation and Disease Spectrum 5 5.0 Risk Factors 5 6.0 Microbiological Investigation 5 7.0 Treatment 6 8.0 Control Measures 6 9.0 Staff Carriage 7 10.0 Infection Control Measures 7 10.1 Hand Hygiene 7 10.2 Isolation of patients and environmental cleaning 7 10.3 Transfer of patients with ESBL 8 10.4 Control of antibiotic usage 8 References 9 Appendix 1: Antibiotic prophylaxis in surgery (Adults) 10

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Purpose This is a clinical and infection control protocol that sets out management standards for patients infected with ESBL producers to ensure appropriate management of the infection and prevent spread within the hospital. This conforms to the revised hygiene code 16 December 2009 requirements. 1.0 Introduction Since 2003, new highly resistant strains of the bacterium Escherichia coli have become widespread in England and parts of Northern Ireland. These strains of E. coli are able to destroy a large number of common antibiotics, making the infections they cause very difficult to treat. The bacteria produce enzymes called extended-spectrum β-lactamases (ESBLs) that destroy, and confer resistance to, antibiotics.1

ESBL-producing microbes are not new, having first been recognised in the 1980s. But the new strains produce a particular type of ESBL, the CTX-M type, which is able to break down a wider range of antibiotics. These strains were unrecorded in the UK prior to 2000. They have spread rapidly since 2003, causing infections such as urinary tract infections (UTIs) in hospital patients as well as those treated in the community. 1

Infections with ESBL-producing E. coli are occurring in both community and hospital patients. Earlier ESBLs-not belonging to the CTX-M family-were largely identified in another bacterium, Klebsiella, and were almost exclusively associated with hospitalised patients, mostly in specialised care e.g. cancer care units and intensive care. 1

CTX-M β-lactamases have spread extensively in E. coli in England in a short period of time. Most CTX-M-producing E. coli are exceptionally resistant to multiple antibiotics. These include penicillins and cephalosporins, two of the most important and widely used classes of antibiotics. As a result, there are very limited options for oral treatment for mild to moderate infections. One option, fosfomycin, is not readily available in the UK. Serious infections require the use of very powerful antibiotics, such as carbapenems (Meropenem, Ertapenem and Imipenem). 1

Epidemiological studies revealed that a number of patients (often elderly and with serious illness) who became infected with CTX-M-producing E. coli had subsequently died. An independent clinical analysis of 54 patients who died in hospital, and who had a history of infection or colonization with ESBL-producing E. coli, concluded that these organisms had contributed directly to the death of 10 patients (19 per cent). In a further four cases there was some evidence that infection may have contributed to death, but it was not conclusive. Most of the patients were elderly and had one or more potentially fatal diseases.1

A survey undertaken by the health protection agency (HPA) in 2004 found that many diagnostic laboratories were using methods that would not detect CTX-M-producing E. coli and would result in inappropriate advice being given to doctors. In addition, only half of the laboratories that had investigated ESBL producers had submitted samples to the Agency's Reference Laboratory for further characterisation. Just two of these laboratories had reported these as 'serious untoward incidents'. Guidelines issued by the

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Agency in 2004 have substantially rectified the testing/detection issues, as confirmed by a follow-up survey in 2005. 2

There is evidence that ESBL-producing bacteria are carried in faecal matter, which may imply spread via the food chain, thereby producing a reservoir of multi-resistant bacteria in the gut that may then cause urinary infections in vulnerable patients.1 Studies have failed to demonstrate clear links with any particular food products or environmental source in the UK.

2.0 Local epidemiology

At BNHFT laboratory testing methods have been updated to reflect HPA guidance and ensure that ESBL producers can be detected. A wider, standardised range of antibiotics are tested so that emerging resistances, including that due to ESBL production, are detected early.

Guidance to local GPs has been given in form of newsletter communications as well as training sessions. Guidance on the submission of urinary specimens to the laboratory has also been issued.

Locally ESBL producers are not very prevalent. However, a rise in infections mainly in the community, in elderly patients with or without urinary catheters and recent hospital admissions, has been documented (see table below). All the isolates fro GPs and most of the hospital isolates were from urines.

Table 1: ESBL producers isolated from inpatients 2007 to Feb 2010 BNHFT

Spec 2007 2008 2009 2010 Grand TotalAbdominal wound 1 1Blood Culture 2 4 6Foot Swab 1 1Pus Swab 1 1Sputum 1 1 2Urine 7 12 34 7 60Wound swab 1 1Grand Total 13 16 36 7 72

Junior medical staff are provided with local updates of microbial resistance patterns to inform therapeutic decisions and improve infection control measures (e.g. with respect to a UTI patient admitted from the community with proven or suspected ESBL-positive E. coli).

3.0 Clinical significance of ESBLs ESBL producers are clinically significant because:

• Delayed recognition and inappropriate treatment of severe infections caused by • ESBL producers with cephalosporins has been associated with increased

mortality • ESBL-mediated resistance is not always obvious in vitro to all cephalosporins • Many ESBL producers are multi-resistant to non-β-lactam antibiotics such as

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• quinolones, aminoglycosides and trimethoprim, narrowing treatment options. • Some ESBL producers achieve outbreak status, spreading among patients and

locales 4.0 Clinical presentation and disease spectrum E. coli are one of the most common bacteria causing infections in humans, particularly urinary tract infections (UTIs) and intra abdominal infections. These infections can sometimes progress to cause more serious infections such as septicaemia which can be life threatening. ESBL-producing strains of E. coli and Klebsiella species are more difficult to treat because of their antibiotic resistance. It is very rare for E coli to cause infections elsewhere e.g. skin and soft tissue or chest infection unless the patient is diabetic, immunocompromised or in a high dependency unit.

Klebsiella sp. can cause severe lower respiratory tract infections in debilitated, alcoholic or immunocompromised patients. Both Klebsiella and E. coli can rarely cause infections related to venous access devices.

There is a very specific strain of E. coli called E. coli O157, which causes food poisoning and sometimes haemolytic uraemic syndrome. It is a completely different strain. The ESBL-producing E. coli are associated with UTIs rather than food poisoning.

5.0 Risk factors

Most of the infections have occurred in people with other underlying medical conditions who are already very sick, and in elderly people. Patients who have been taking antibiotics or who have been previously hospitalised are mainly affected.

The actual source or origin of this mechanism of resistance is not known.

6.0 Microbiological investigation

A urine sample should be sent to the laboratory as per the standard protocol for investigation of UTIs in the community and in hospital. The standard operating procedures in the lab will allow for detection and further investigation of any ESBL producer. Patients suspected of having sepsis should have blood cultures taken with appropriate clinical details documented on request form. Relevant samples e.g. pus, sputum, blood cultures or skin swabs should be sent from patients suspected of having or found to have abscesses (regardless of site), respiratory tract infections (ventilator associated or otherwise), line related infections and skin and soft tissue infections respectively.

If a patient is known to be colonised with or had an infection in the past with an ESBL producer, the lab should be informed by documenting the information on the request form.

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7.0 Treatment

The important factor in successfully treating an ESBL producer is quick diagnosis and recognition that the bacteria causing infection are resistant to antibiotics, so that the most appropriate treatment can be prescribed quickly.

There are only two oral antibiotics (Nitrofurantoin and Fosfomycin) and few intravenous antibiotics (cabapenem group e.g. Ertapenem and meropenem and Tigecycline) that are effective against such infections. Some strains are resistant to Nitrofurantoin. Others appear sensitive in vitro to beta lactamase inhibitor antibiotics e.g. Tazocin and Coamoxyclav but the in vitro activity of these antibiotics might not be reliable. Some strains are sensitive to aminoglycosides e.g. gentamicin which has been successfully used to treat these infections using a single daily dose of 5 mg/kg/day.

Which antibiotics are these infections resistant to?

Most ESBL-producing E. coli are resistant to cephalosporins, penicillins, fluoroquinolones, trimethoprim, tetracycline and some other antibiotics, leaving very limited options for oral treatment in the community, usually only nitrofurantoin and fosfomycin. As a result of that some patients are having to be referred to hospital for intravenous antibiotics.

Key points to remember when treating an ESBL producer infection:

• Same rules apply: if simple UTI treat for 3 days, unless a male patient, suspected prostatitis or patient with a heart valve lesion or prosthetic heart valve.

• Nitrofurantoin works for sensitive strains and for lower UTI only, not pyelonephritis.

• Fosfomycin: not readily available in the UK, also for lower UTI only • Coamoxyclav/Cefixime combinations Or Pivmecillinam/ coamoxyclav

combination : no evidence, potentially antagonistic • Tigecycline is active against ESBL producers but is not excreted in urine and

therefore not suitable for treating UTIs. • Intravenous Carbapenem antibiotics form the first line treatment for hospitalised

patients with ESBL producer infections. Ertapenem should be used when infection is confirmed to be due to an ESBL after discussion with a microbiologist and as per the antibiotic policy.

• Antibiotic treatment should be stopped as soon as infection is cleared to avoid selection of more resistant organisms.

• All other supportive clinical measures should be observed to prevent and/or treat complicating sepsis

8.0 Control measures

Robust infection control measures are always important to prevent the spread of infection. These include interventions, such as, hand washing and patient isolation. It is also important to ensure that antibiotics are prescribed only when needed, in the right dose, for the right duration, so as to reduce resistance developing in bacteria.

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9.0 Staff carriage There have been no published reports implicating staff carriage as a source of patient colonisation or infection. Screening of staff for carriage during an outbreak or as part of an investigation is unhelpful and may cause considerable stress. 10.0 Infection control measures It is important to control the emergence and spread of ESBL for the reasons stated previously: the limited therapeutic alternatives, the increasingly compromised in-patient population, and the potential for transfer of resistance to other pathogenic bacteria and development of further resistance e.g. to carbapenem. The epidemiology is complex: hospitals may be affected by sporadic cases of ESBL, epidemics or endemic colonization and infection. Each of these situations will need to be managed in different ways, depending on the risk to the patients involved. As with all other infection control interventions, the quality of clinical care must not suffer as a result of the precautions implemented. Because of the uncertainty surrounding the management of ESBL, discussion between the infection control team and the clinical staff is essential. Control measures must be informed by a risk assessment. This will include the extent and site of patient infection, the presence of intravenous and urinary catheters, whether the patient is incontinent of urine or not and the susceptibility to infection of patients on the affected wards. Table two below summarises the infection control precautions indicated for control of ESBL infections. 10.1 Hand hygiene Effective hand hygiene is the most important measure to prevent and control the spread of antimicrobial resistant organisms. Hands should be decontaminated between each patient contact, whether or not the patient is known to be infected with ESBL. Alcohol-based solutions or gels are effective and can be used as long as hands are socially clean. 10.2 Isolation of patients and environmental cleaning The decision to isolate individual patients affected by ESBL should be based on the clinical needs and risk assessment described above, by the clinical team caring for the patient in conjunction with the ICT. Ideally, patients infected with ESBL should be source isolated in single rooms. However, where there are larger patient numbers and insufficient isolation rooms, patients should be cohorted in bays on the open ward. Patients with ESBL and incontinence or venous or urinary catheters or intra abdominal drains are at a higher risk of spreading ESBL and must be given priority for single rooms.

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Where there is more than one patient with the same ESBL organism isolated from the same unit/ward, an outbreak team as per the Diarrhoea and Vomiting Outbreak Management Protocol IC/274/09 should be convened and an investigation undertaken. Case definitions should be agreed and dates of admission and discharge, ward and bed locations of all infected and colonised patients documented, along with time line analysis of patient activity such as movement to, and from, theatre. When several patients are infected at the same time, cohort-nursing as advised by the ICT is acceptable During ESBL outbreaks, the ward environment may become heavily contaminated and will need further thorough cleaning following the discharge of the patients. There is no evidence that one cleaning regimen is better than another for eliminating ESBL producers. The side-room in which a patient with ESBL has been cared for should be cleaned after the patient’s discharge with a chlorine-releasing agent (500 ppm available chlorine) such as hypochlorite or 1-2% phenolic disinfectants with special attention to horizontal surfaces and dust-collecting areas. Bedding and curtains should be changed as part of terminal cleaning. 10.3 Transfer of patients with ESBL

In general, ESBL neither present a risk to normal people in the community, nor to patients in residential or nursing homes who do not have catheters, wounds or other lesions. However Where patients infected or colonised with multiresistant bacteria, or exposed to it but screened and thought to be clear, are being transferred to another hospital or care provider, clinical staff should ensure that the receiving area is aware of the patient's status and the context of the exposure to multi-resistant bacteria, and the Infection Control Team at that hospital should be informed. This needs to happen before the transfer takes place. Colonisation with multiple-resistant organisms, must never be a reason for refusing admission if there are clear clinical reasons for the transfer.

Standard precautions during and after discharge are sufficient to prevent spread 10.4 Control of antibiotic usage The emergence and spread of ESBL is encouraged by the use of certain antimicrobials. The use of the cephalosporin has been implicated in the emergence of ESBL. It is good clinical practice not to use any antimicrobial unnecessarily and clinical units should adhere to the trust wide antibiotic policy. Antibiotic prophylaxis for surgery should be as per trust policy (single dose at induction) to reduce antibiotic selection pressure.

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Table 2: summary of infection control precautions for ESBL producers (contact precautions)

Contact Hand washing Before an after patient contact Gloves On entering room, during care e.g. When likely to touch, blood,

body fluids and contaminated items Masks During procedures likely to generate contamination with blood and

body fluids Eye/face protection

During procedures likely to generate contamination with blood and body fluids

Apron/gown On entering if contact with patient or environment anticipated Equipment As per decontamination policy Cleaning As per cleaning standards and description above Linen As per policy. Regard as infected Isolation room Single room and minimise time outside, unless advised by ICT References

1. Investigations into multi-drug resistant ESBL-producing Escherichia coli strains causing Infections in England. Health Protection Agency. September 2005

2. Laboratory detection and reporting of bacteria with extended spectrum ß-lactamases. Health Protection Agency. 2004.

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APPENDIX 1

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