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CABI: Clinical management of Complicated intra-ABdominal Infection in United Kingdom hospitals Version 3 Date 01.08.2016 Protocol CABI: Clinical management of Complicated intra-ABdominal Infection in United Kingdom hospitals Principal Investigators: Mr Dermot Burke (Surgery), Dr Rachel Hyland (Radiology), Dr Andrew Kirby (Microbiology), Dr Anne Melhuish (Infectious Diseases), Dr Shafaque Shaikh (Surgery) Version Number: 3 01.08.2016 ____________________________________________________________________________________________ i CABI: Clinical management of Complicated intra-ABdominal Infection in United Kingdom hospitals Version 3 Date 01.08.2016 TABLE OF CONTENTS PAGE TABLE OF CONTENTS .............................................................................................................. II PROTOCOL SUMMARY ............................................................................................................ III 1.1 Background Information .......................................................................................... 1 1.2 Rationale ................................................................................................................ 1 1.3 Study Objectives ..................................................................................................... 2 1.4 Study Outcome Measures ...................................................................................... 2 1.5 Study design ........................................................................................................... 3 1.6 Subject Inclusion Criteria ........................................................................................ 3 1.7 Subject Exclusion Criteria ....................................................................................... 3 1.8 Strategies for Recruitment and Retention ............................................................... 6 1.9 Study Procedures/Evaluations/ Questionnaire ........................................................ 6 1.10 Sample Size Considerations ................................................................................... 6 1.11 Final Analysis Plan ................................................................................................. 6 1.12 Publication/data sharing policy ................................................................................ 7 1.13 References ............................................................................................................. 7 APPENDICES ............................................................................................................................. 8 ____________________________________________________________________________________________ ii CABI: Clinical management of Complicated intra-ABdominal Infection in United Kingdom hospitals Version 3 Date 01.08.2016 PROTOCOL SUMMARY Title: CABI: Clinical management of Complicated intra-ABdominal Infection in United Kingdom hospitals Précis: A multicentre audit and service evaluation of complicated intra-abdominal infections (CABIs) in the United Kingdom to assess current practice against national guidelines for the management of CABI and to describe the surgical and antibiotic management and outcomes of CABI. Data can be collected from August 2016-May 2017. Objectives: Primary: To define compliance with guidance for the management of CABI (audit). Secondary: To describe clinical features and outcomes of CABI in order to determine the efficacy of standard surgical and antibiotic management of CABIs (service evaluation). Population: Patients will be included according to the following criteria: Adult patients (> 18 years) with confirmed CABI between August 2016 and February 2017. Patients will be excluded if they had a CABI diagnosed within the previous year, if antibiotics for their CABI was started >7 days prior to screening and if they do not live in the area served by the relevant hospital, given the requirement for follow up data. No formal sample size calculation was performed. Number of Sites: As many UK sites as possible will be involved in this project. Study Duration: 4-9 months (1-6 months recruitment, 3 months follow up) Study investigators CABIs are managed by infectious disease doctors, microbiologists, radiologists and surgeons. The data collected on the management of these infections reflects this shared management. Agreeing the involvement of a named staff member from all specialties is likely to help all data fields be completed. ____________________________________________________________________________________________ iii CABI: Clinical management of Complicated intra-ABdominal Infection in United Kingdom hospitals Version 3 Date 01.08.2016 Schematic of Study Dates: April to August 2016 Study site invited to participate via HQIP National Infection Trainee Collaborative National Surgical Trainee Collaborative April to August 2016 Study site identifies investigators April to August 2016 Pilot August 2016 to May 2017 Data collection May 2017 to June 2017 Data submitted July 2017 to August 2017 Data analysis September to October 2017 Investigators analyse manuscript derived from submitted data November 2017 The collaborative submit agreed manuscript ____________________________________________________________________________________________ iv CABI: Clinical management of Complicated intra-ABdominal Infection in United Kingdom hospitals Version 3 Date 01.08.2016 1.1 Background Information Complicated intra-abdominal infection (CABI) is defined as an infection within the abdomen where there is perforation of a viscus or a collection which is believed to be infected. CABI is associated with increased morbidity and mortality (Solomkin 2010). CABI occurs across a range of clinical specialties including colorectal surgery, hepatobiliary surgery and gynaecological surgery. A recent RCT was undertaken to compare 4 days vs approximately 8 days antibiotic treatment for the antibiotic management of CABI after a source control procedure. No significant difference in outcomes was identified, but there was a high rate of complications (approx. 20%) in both treatment groups (Sawyer 2015). A recent case note review (35 patients) of organ space surgical site infections after colorectal surgery in Leeds suggested that the infections are heterogeneous, with abscesses of variable size and number and that they are infrequently managed with radiological drainage of the abscess (17%). Organ space SSIs were found to have a high rate of relapse (40%) (Rothwell 2016, unpublished). Guidelines for the management of CABI do not provide comprehensive evidence based recommendations with which to guide management of most CABIs. Guidelines do however provide expert opinion based recommendations on some aspects of the management of CABI for use as audit standards (Solomkin 2010). We intend to undertake a clinical trial of short course (≤ 10 days) vs long course (28 days) of antibiotics for the treatment of CABI. In order to design this trial it is necessary to describe the patient population who suffer CABI, define the current management strategies for CABI and determine outcomes associated with these management strategies. 1.2 Rationale The optimal strategy for the management of CABIs is uncertain due to a lack of clinical evidence. In order to obtain such evidence clinical epidemiological data are required to define the characteristics of CABIs in the United Kingdom NHS setting. These data will inform the design of a study into CABI e.g. outcome rates to inform sample size calculations. To obtain such data an audit of practice related to the management of CABI will be carried out in combination with a service evaluation into the management of CABI. ____________________________________________________________________________________________ 1 CABI: Clinical management of Complicated intra-ABdominal Infection in United Kingdom hospitals Version 3 Date 01.08.2016 1.3 Study Objectives 1- To describe the demographic and clinical characteristics of patients with CABIs 2- To describe practice variation in the management of CABI 3- To obtain outcome rates in patients with CABI 4- To associate management strategies with outcomes 5- To assess compliance with audit standards derived from the Infectious Disease society of America guidelines for the diagnosis and management of CABI. CABI definition: The diagnosis of CABI will be assigned with: Intra-operative confirmation of an abscess, or A combination of radiological AND clinical features consistent with CABI including a fluid collection and/or perforated viscus, a temperature of ≥38 or less than 35 degrees and a neutrophilia (neutrophil count > 7.5 x 10*9/L). Fever (or hypothermia) and raised neutrophil count may not be present at the actual time of recruitment: collaborators should note they may have preceded the date of screening. Day 0: The first day of infection will be defined as the first day antibiotic therapy was initiated for the treatment of CABI. This date may precede or follow the day CABI was suspected radiologically. 1.4 Study Outcome Measures 1. Relapse of CABI within 90 days of diagnosis 2. Time till relapse of CABI 3. Number of days hospitalization within 90 days of diagnosis 4. Death (all cause and attributable) within 90 days of diagnosis 5. Compliance with audit standards, see Appendix. Relapse of a CABI definition: The diagnosis of a definite CABI relapse will be assigned with: Intra-operative confirmation of an abscess, or ____________________________________________________________________________________________ 2 CABI: Clinical management of Complicated intra-ABdominal Infection in United Kingdom hospitals Version 3 Date 01.08.2016 A combination of radiological AND clinical features consistent with CABI including a fluid collection and/or perforated viscus, a temperature of ≥38 or less than 35 degrees and a neutrophilia (neutrophil count > 7.5 x 10*9/L). Fever (or hypothermia) and raised neutrophil count may not be present at the actual time of recruitment: collaborators should note they may have preceded the date of screening. In the absence of radiological imaging, but where no other source of infection was identified, and the patient was managed for a relapsed CABI, a diagnosis of probable CABI will be assigned. A relapse can only occur after source control and/or antibiotic therapy to manage the primary CABI has been considered to be successful. This will normally be demonstrated by antibiotics having been stopped and there being no further source control procedures planned. 1.5 Study design Design: Observational multicentre cohort study. The study population are hospitalized adults within NHS hospitals with CABI. Timeline 1.6 Start data: August 2016, Completion of enrolment: February 2017 End of data collection: May 2017 Duration of follow up: 90 days post CABI diagnosis Data collection methods: Medical case note review Subject Inclusion Criteria Patients may be included according to the following criteria: adult patients (> 18 years) with CABI between August 2016 and February 2017. 1.7 Subject Exclusion Criteria Patients are excluded if they had a CABI diagnosed within the previous year, if antibiotic treatment for their CABI was started >7 days prior to screening and if they do not live in the area served by the relevant hospital given the requirement for follow up data. ____________________________________________________________________________________________ 3 CABI: Clinical management of Complicated intra-ABdominal Infection in United Kingdom hospitals Version 3 Date 01.08.2016 The conditions excluded are intended to ensure we are studying primary episodes of CABI for which there is evidence there may be a high risk of relapse, that the cases included are not biased towards more complicated cases, and to exclude primary appendicitis managed surgically for which good data already exist. In the case of necrotising pancreatitis, SPB and CAPD peritonitis these pathologies are excluded as they consist of a discrete disease process. Conditions for inclusion and exclusion are summarised in Table 1. These lists are for guidance and are not exhaustive; clarification can be sought on other conditions not listed. ____________________________________________________________________________________________ 4 CABI: Clinical management of Complicated intra-ABdominal Infection in United Kingdom hospitals Version 3 Date 01.08.2016 Table 1: Clarification of which infections are to be included and excluded from CABI Included conditions Excluded conditions Post-operative surgery CABI including colorectal (including appendiceal), biliary, small bowel and gastric surgery (including iatrogenic perforations) e.g. Peri-anastomotic abscess Uncomplicated cholecystitis/cholangitis/gall bladder empyema (no perforation or extrabiliary abscess) Gastrointestinal fistula communicating with the peritoneal space Skin and soft tissue infection/abscess not communicating with the peritoneal space Oesophageal rupture into the peritoneal space Spontaneous bacterial peritonitis & continuous ambulatory peritoneal dialysis & perforated duodenal/gastric ulcer Ischaemic bowel and volvulus with perforation Primary complicated or uncomplicated appendicitis managed surgically. Perforations associated with malignancies Intraabdominal infection associated with pancreatitis Complicated diverticulitis & perforated Meckel’s diverticulum Adenexal abscess without communication with the peritoneal cavity Clostridium difficile colitis with perforation Pelvic inflammatory disease CABI secondary to inflammatory bowel disease pathology Primary complicated appendicitis managed conservatively Renal/Adrenal/Liver/Spleen abscess communicating with the peritoneal cavity. Adenexal abscess communicating with the peritoneal cavity ____________________________________________________________________________________________ 5 CABI: Clinical management of Complicated intra-ABdominal Infection in United Kingdom hospitals Version 3 Date 01.08.2016 1.8 Strategies for Recruitment and Retention Patients will not be formally recruited. Information governance approval will be requested at each site to complete this study as an audit and service evaluation. Information governance approval has been provided for the lead site-Leeds Teaching Hospitals NHS Trust. Each investigator will submit a minimum of 7 patients to the study. To reduce bias only patients with a new diagnosis of CABI will be included. Investigators will also be asked to, where possible, recruit consecutively identified patients who meet the inclusion criteria. No formal screening protocol is recommended. Possible screening processes could involve: Identification of consecutive patients on ward round Screening of a cohort of patients on a defined day or week, or at a particular time each day Reviewing patients having undergone radiological imaging Reviewing radiological reports on electronic results servers Screening should try and avoid biasing to more complicated patients e.g. only including those who were identified during out of hours work and so may be biased to more unwell patients. 1.9 Study Procedures/Evaluations/ Questionnaire Data will be collected on case report forms, see Appendix S1 for the required dataset. 1.10 Sample Size Considerations Each investigator will be required to submit a minimum 7 patients’ data to the national data set. Where possible it is anticipated this recruitment target will be exceeded. 1.11 Final Analysis Plan Data will be requested within two months of the end of study date. Data analysis will be completed over the subsequent four months. Results are reported in accordance with the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement for observational studies (von Elm 2007). Data will be analysed with reference to compliance with audit standards. Data will be analysed as proportions. Management strategies will be compared to outcomes, with tests for significant differences in outcomes analysed according to stratified management strategies. ____________________________________________________________________________________________ 6 CABI: Clinical management of Complicated intra-ABdominal Infection in United Kingdom hospitals Version 3 Date 01.08.2016 1.12 Publication/data sharing policy All investigators submitting data on seven patients will be eligible to review the manuscript written by the principal investigators (Burke, Hyland, Kirby, Melhuish, Shaikh) and therefore contribute academically. This academic contribution will be recognised with authorship on submitted manuscripts. 1.13 References Solomkin JS, Mazuski JE, Bradley JS, Rodvold KA, Goldstein EJ, Baron EJ, et al. Diagnosis and management of complicated intra-abdominal infection in adults and children: guidelines by the Surgical Infection Society and the Infectious Diseases Society of America. Clin Infect Dis. 2010;50(2):133-64. Rothwell A, Burke D, Burnside G, Kirby A. Characteristics of Organ Space Surgical Site Infection after colorectal surgery. Unpublished von Elm E, Altman DG, Egger M, Pocock SJ, Gotzsche PC, Vandenbroucke JP. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. Lancet 2007; 370: 1453–1457. ____________________________________________________________________________________________ 7 CABI: Clinical management of Complicated intra-ABdominal Infection in United Kingdom hospitals Version 3 Date 01.08.2016 APPENDICES Demographics and Baseline Data Local Patient ID: Study ID: Gender: Initial admission date: Age range 18-29 30-39 40-49 50-59 60-69 70-79 80-89 90-99 ≥100 Site (origin) of CABI (please circle any that apply) Appendix Psoas muscle Biliary Reproductive tract Colon Small bowel Kidney/Adrenal Spleen Liver Unknown Peptic Ulcer Other (please state) Underlying pathology (please circle any that apply) Adnexal abscess Immunosuppression Anatomical abnormality Ischaemic bowel Appendicitis Pancreatitis Biliary stones Pelvic inflammatory disease Cancer Perforated peptic ulcer Chemo-radiotherapy in last 12 months Perforated abdominal viscus at onset of CABI Clostridium difficile colitis Post-operative complication (< 6 months) Crohn’s disease Ulcerative colitis Diverticular disease Spontaneous Drug reaction Volvulus Fistula Colo-cutaneous Colo-vaginal Colo-urinary Colo-intra-abdominal Unknown Other (please state) Other Iatrogenic perforated bowel ____________________________________________________________________________________________ 8 CABI: Clinical management of Complicated intra-ABdominal Infection in United Kingdom hospitals Version 3 Date 01.08.2016 Primary Management of CABI Source control procedure as part of primary CABI management plan? (please circle) Radiological (CT guided) percutaneous drainage Radiological (U/S guided) percutaneous drainage Surgical: Resection and anastomosis or closure Surgical: drainage only Surgical: Resection and proximal diversion Surgical: Closure of perforation only with/without washout/drain Surgical: Drainage and diversion None Not radiologically drainable If no source control procedure, please select from the reasons opposite: (please circle) Not surgically drainable Clinical decision to manage with antibiotics Patient clinically responded to antibiotic therapy Patient refused drainage Patient too unwell for radiological drainage Patient too unwell for surgical drainage Unknown Anticoagulated Other (please give details) If multiple collections are present, and the patient underwent drainage, were all collections drained? Were cultures sent at the time of the CABI being diagnosed (blood cultures +/-samples from the site of infection)? Co-amoxiclav (+/metronidazole) Yes No Unknown Yes No Unknown Piperacillin-tazobactam (+/- aminoglycoside) Cefuroxime and metronidazole Primary IV antibiotic6/7 regimen ____________________________________________________________________________________________ 9 CABI: Clinical management of Complicated intra-ABdominal Infection in United Kingdom hospitals Version 3 Date 01.08.2016 Carbapenem Tigecycline Quinolone and metronidazole (+/- beta lactam +/- glycopeptide) Antifungal Glycopeptide, Aminglycoside and metronidazole Aminoglycoside and metronidazole (+/- betalactam) Glycopeptide, beta-lactam and metronidazole Temocillin, metronidazole and glycopepetide or beta-lactam Unknown/Missing Other (please state): None Duration of IV treatment8 (days)? Primary oral antibiotic regimen6/7 Oral cephalosporin and metronidazole Co-amoxiclav Quinolone and metronidazole (+/- beta lactam) Unknown/Missing Antifungal Other (please state): None Duration of oral treatment8 (days)? Change of primary antibiotic treatment for initial CABI due to antibiotic resistance? Yes No Unknown Change of primary antibiotic treatment for initial CABI due to failure of antibiotic therapy? Yes No Unknown Was an additional or unplanned source control procedure required as a result of failure of the primary CABI management plan? Yes No Unknown What date was the additional or unplanned source control procedure? (if multiple give earliest date only) Outcomes Date of CABI diagnosis Relapse within 90 days3 Yes-Definite If yes, date of relapse and date of CABI diagnosis? Date of relapse Failure of antibiotic treatment Aetiology of relapses (circle all that apply) Death (within 90 days)? Yes If yes, date of death Number of days hospitali Date of death: Yes-Probable No Failure of source control Unknown/Other No ____________________________________________________________________________________________ 10 CABI: Clinical management of Complicated intra-ABdominal Infection in United Kingdom hospitals Version 3 Date 01.08.2016 Number of days hospitalisation (within the 90 days after CABI diagnosis)? Date improved: Date patient has clinically improved from initial CABI: Apyrexial (<38) for > 24 hours and WCC <11? Or discharged before Apyrexial (<38) for > 24 hours and WCC <11? Primary Imaging characteristics5 (Please discuss with a radiologist when answering the questions) Date of imaging Modality of imaging used to make the diagnosis Does imaging demonstrate a collection or free fluid? Single Multiple <5 >5 Maximum depth2 of biggest collection (cm) Anastomosis Yes No Unknown Evidence of Yes fistulation No Not stated Radiological Yes drainage feasible in No radiologist’s opinion? CT US Collection(s) Free fluid Neither Collection(s) Free fluid Neither Collection Evidence of leak Yes No Unknown If Yes, location of fistula? If yes, would radiological drainage be advised? Yes No: Surgical intervention preferred No: Collection too small No: Please state reason Microbiological characteristics of samples relevant4 to CABI as judged by clinician (Please liaise with a microbiologist to obtain this information) Staphylococcus aureus MRSA Enterococcus Vancomycin resistant Enterococcus Coliform (Enterobacteriaceae) Augmentin resistant coliform Yes Yes Yes Yes Yes Yes No No No No No No ____________________________________________________________________________________________ 11 CABI: Clinical management of Complicated intra-ABdominal Infection in United Kingdom hospitals Version 3 Date 01.08.2016 Piperacillin-tazobactam resistant coliform AmpC/ESBL resistant coliform Carbapenemase producing coliform (CPE) Ciprofloxacin resistant coliforms Anaerobes Yeasts Able to collect this information? Yes Yes Yes Yes Yes Yes Able No No No No No No Unable Case report form advice 1- Where an event has not been identified after reviewing notes, please report this as having not occurred i.e. answer no to the question. 2- Depth of collection does not relate to the location of the collection in relation to the skin. 3- Relapse of a CABI definition: The diagnosis of a CABI relapse will be assigned as definite with: A combination of radiological AND clinical features consistent with CABI or Intra-operative confirmation of an abscess or perforated abdominal viscus, or Pathogenic bacteria from a sterile intra-abdominal site in combination with clinical or radiological features or In the absence of radiological imaging, but where no other source of infection was identified, and the patient was managed for a relapsed CABI, a diagnosis of probable CABI was assigned. A relapse can only occur after surgical and antibiotic therapy to manage the primary CABI has been considered to be successful. This will normally be demonstrated by antibiotics having been stopped and there being no further source control procedures being planned. 4- Relevant clinical samples include blood cultures, surgical samples, intraabdominal drain samples and surgical wound samples (excluding skin bacteria such as coagulase negative staphylococcus, Diptheroids, Corynebacteria) 5- Where multiple radiological tests have been performed please report only the imaging completed closest to the time of CABI diagnosis 6- Antibiotics and antibiotic class: Aminoglycosides includes: Amikacin and Gentamicin, Beta-lactams includes all penicillins (e.g. amoxicillin), cephalosporins, carbapenems and aztreonam. Carbapenems includes: Ertapenem, Imipenem and Meropenem. Glycopeptides includes: Teicoplanin and Vancomycin. Quinolones includes: Ciprofloxacin and levofloxacin 7- The primary antibiotic is the predominant (jn terms of number of days) antibiotic administered) 8- Duration of treatment includes all IV/oral antibiotics administered from the start of treatment until antibiotics were stopped. Audit standards 1- A CT scan is the preferred radiological imaging modality to investigate for CABI. 2- A source control procedure should be attempted in the management of CABI 3- Microbiological cultures should be sent at the time of the CABI being diagnosed (blood cultures +/-samples from the site of infection). ____________________________________________________________________________________________ 12 CABI: Clinical management of Complicated intra-ABdominal Infection in United Kingdom hospitals Version 3 Date 01.08.2016 4- If resistant bacteria were identified at the time of initial intervention and there are persistent signs of infection, pathogen-directed therapy is recommended. 5- Antimicrobial therapy of established infection should be limited to 4–7 days, unless it is difficult to achieve adequate source control. ____________________________________________________________________________________________ 13