EXTENDed Antibiotic Durations Compared to Standard Durations for Patients With Complicated Intra-abdominal Infection.
NCT ID: NCT05148702
Last Updated: 2024-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
1166 participants
INTERVENTIONAL
2022-10-10
2025-12-31
Brief Summary
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Detailed Description
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The EXTEND trial aims to find out whether a fixed extended duration of 28 days of antibiotics is superior to the current standard duration (typically 7-18 days) based on clinical outcomes and quality of life assessed over 180 days of follow up. Cost effectiveness will also be determined.
A target of 1166 patients will be recruited from ICUs and hospital in-patient wards across approximately 30 NHS trust hospitals. Only patients that are able provide consent (or those with a consultee able to confirm whether the patient would wish to be included in the study) can take part in the trial. They will receive antibiotics as prescribed by their treating clinician, but the duration of treatment will be determined by randomisation. Patients will have equal chance of randomisation to the standard care arm, in which the antibiotic duration will be determined by the treating clinician, or the intervention arm, a fixed duration of 28 days treatment.
Patients (or a personal consultee) will complete a quality of life questionnaire at baseline and 30, 60 and 180 days after randomisation. At follow-up timepoints they will also complete questionnaires on antibiotic use and health care resource use. Hospital notes will be used to collect data on inpatient admissions, relapse and further infections.
The study is Sponsored by the University of Leeds
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Standard care
Clinician decided antibiotic treatment duration
Antibiotic - standard duration
Clinician decided antibiotic and duration of treatment
Fixed-extended-duration antibiotics
28 day antibiotic treatment duration
Antibiotic - fixed-extended-duration
Clinician decided antibiotic for a fixed duration of 28 days.
Interventions
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Antibiotic - standard duration
Clinician decided antibiotic and duration of treatment
Antibiotic - fixed-extended-duration
Clinician decided antibiotic for a fixed duration of 28 days.
Eligibility Criteria
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Inclusion Criteria
* Being treated with antibiotics until the point of randomisation, but within 10 days of initiation of effective antibiotic treatment\*\* for cIAI
* Ability to provide informed consent by the patient or their consultee.
* More than 72 hours\*\*\* of active in-patient management for the patients cIAI is required
* In the event that the patient is re-admitted to hospital during the trial period, they are likely to be admitted to a hospital participating in the EXTEND trial.
Patients will be included in the trial whether or not they undergo surgical or radiological source control procedures.
\* cIAI is defined by the following case definition:
* A clinical presentation consistent with cIAI, plus
* Fever (temperature of ≥ 37.8°C) and/or a neutrophilia (\> 7.5×109/L) and/or neutropaenia (\<1.8 x 109 /L) and/or intestinal pathogens cultured from sterile sites (closed peritoneum or blood) around the time of cIAI diagnosis, plus
* Evidence of pathologic findings on radiologic examination, or
* Evidence of pathologic findings at operation
\*\* The first day of effective antibiotic treatment will be determined by the patient's clinical team or clinical research team. Antibiotics that do not count towards these 10 days of effective treatment are:
* Antibiotic prophylaxis e.g., penicillin for splenectomy, elective surgery antibiotic prophylaxis, UTI prophylaxis
* Treatment for other infections that is not effective for cIAI e.g., cystitis. Antibiotics that re often used for cystitis and aren't effective for cIAI include Cephalexin, Fosfomycin Trimethoprim, Nitrofurantoin, and Pivmecillinam.
* Oral antibiotics prescribed to treat infection prior to hospitalisation
* Previous courses of treatment antibiotics: A previous course is one stopped for 48 hours or more
* The further 72 hours starts from the first day of effective antibiotic treatment i.e., for a patient admitted to hospital with a cIAI, 3 days of admission are needed. Where a patient is already in hospital e.g., a post operative patient, a further 3 days of admission are required starting from the point of the first day of effective antibiotic treatment.
Exclusion Criteria
* Traumatic injury to the bowel (including iatrogenic or intra-operative) treated within 12 hours of injury.
* Uncomplicated diverticulitis defined as an episode with a short history and with clinical signs of diverticulitis, with an increased body temperature and inflammatory parameters, verified by computed tomography (CT), and without any sign of complications such as abscess, free air or fistula.
* Grade 1 to 3 appendicitis. To be eligible patient must have Grade 4 or 5 appendicitis defined by the 2017 American Association for the Surgery Trauma Grading System with either generalised peritonitis at surgery, or no or partial source control e.g. radiological drainage
* Non-perforated cholecystitis.
* Ischemic or necrotic intestine without perforation
* Uterine perforation following uterine surgery treated \<six hours following injury.
* cIAIs with a low risk of complications who may receive more than 72 hours antibiotics are not intended to be included, such as those listed above. Traumatic injury to the bowel (including iatrogenic or intra-operative) treated within 12 hours of injury, Uterine perforation following uterine surgery treated within six hours of injury, Perforated gastric ulcer or duodenal ulcer treated within 24 hours of the onset of symptoms). Clinician assessment on the eligibility of patients receiving more than 72 hours of in-patient surgical care and antibiotics for their cIAI may be required in patients who have clinically improved at this point and do not require active surgical care but remain in hospital and on antibiotics.
* Current enrolment in another trial dictating antibiotic treatment duration.
* Previous Clostridium difficile infection
* Infected necrotic pancreatitis
* Concomitant infection requiring ≥4 weeks antibiotic therapy including Intra-hepatic abscess/es planned to be treated with fixed-extended-duration antibiotics of 4 to 6 weeks antibiotics, osteomyelitis, and endocarditis.
* Peritoneal dialysis
* Previously recruited for the EXTEND trial
* Treatment with Interleukin-6 Inhibitors
* High likelihood of death within 72 hours of cIAI randomisation in the opinion of the local Investigator
* Limitations in treatment decided before inclusion. Limitations in treatment that exclude patients from the EXTEND trial are those clinical decisions linked to an expectation the patient will die during this episode of infection.
* Patient with persistent cIAI of more than 6 months duration
16 Years
ALL
No
Sponsors
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University of York
OTHER
University of Birmingham
OTHER
Chesterfield Royal Hospital NHS Foundation Trust
UNKNOWN
University of Leeds
OTHER
The Leeds Teaching Hospitals NHS Trust
OTHER
Sarah Cockayne
OTHER
Responsible Party
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Sarah Cockayne
Research Fellow
Principal Investigators
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Andrew Kirby, MD
Role: PRINCIPAL_INVESTIGATOR
University of Leeds
Locations
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Cwm Taf Morgannwg University Health Board,
Abercynon, , United Kingdom
NHS Grampian
Aberdeen, , United Kingdom
Hywel Dda University Health Board
Aberystwyth, , United Kingdom
Buckinghamshire Healthcare NHS Trust
Aylesbury, , United Kingdom
UniversityHospitals Birmingham NHS Foundation Trust
Birmingham, , United Kingdom
Bolton NHS Foundation Trust
Bolton, , United Kingdom
United Lincolnshire Hospitals NHS Trust - Pilgrim Hospital Boston
Boston, , United Kingdom
University Hospitals Sussex NHS Foundation Trust
Brighton, , United Kingdom
North Bristol NHS Trust
Bristol, , United Kingdom
North Cumbria Integrated Care NHS Foundation Turst
Carlisle, , United Kingdom
Chesterfield Royal Hospital NHS Foundation Trust
Chesterfield, , United Kingdom
University Hospital Coventry & Warwickshire
Coventry, , United Kingdom
County Durham and Darlington NHS Foundation Trust
Darlington, , United Kingdom
Northern Lincolnshire and Goole NHS Foundation Trust - Grimsby
Grimsby, , United Kingdom
Hull University Teaching Hospitals NHS Trust
Hull, , United Kingdom
East Suffolk and North Essex NHS Foundation Trust
Ipswich, , United Kingdom
Leeds Teaching Hospitals NHS Trust
Leeds, , United Kingdom
University Hospitals of Leicester NHS Trust
Leicester, , United Kingdom
Chelsea and Westminster Hospital NHS Foundation Trust
London, , United Kingdom
Guys and St Thomas' NHS Foundation Trust
London, , United Kingdom
Imperial College Healthcare NHS Trust
London, , United Kingdom
King'S College Hospital Nhs Foundation Trust
London, , United Kingdom
East Cheshire NHS Trust
Macclesfield, , United Kingdom
Manchester University NHS Foundation Trust
Manchester, , United Kingdom
Aneurin Bevan University Health Board
Newport, , United Kingdom
Norfolk and Norwich University Hospitals NHS Foundation Trust
Norwich, , United Kingdom
Nottingham University Hospital NHS Trust
Nottingham, , United Kingdom
University Hospitals Plymouth NHS Trust
Plymouth, , United Kingdom
Lancashire Teaching Hospitals NHS Foundation Trust
Preston, , United Kingdom
Barking, Havering and Redbridge University Hospitals Nhs Trust
Romford, , United Kingdom
East Sussex Hospitals NHS Trust
Saint Leonards-on-Sea, , United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, , United Kingdom
North Tees and Hartlepool NHS Foundation Trust
Stockton-on-Tees, , United Kingdom
Sherwood Forest Hospitals NHS Foundation Trust
Sutton in Ashfield, , United Kingdom
Royal Cornwall Hospitals NHS Trust
Truro, , United Kingdom
University Hospitals Sussex NHS Foundation Trust
Worthing, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Role: primary
Related Links
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Other Identifiers
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ISRCTN 72819021
Identifier Type: REGISTRY
Identifier Source: secondary_id
NIHR131784
Identifier Type: -
Identifier Source: org_study_id