Complicated Intra-abdominal InfectionPhase 3EXTENDNCT05148702
EXTENDed Antibiotic Durations Compared to Standard Durations for Patients With Complicated Intra-abdominal Infection.
A Phase 3 study testing Antibiotic - standard duration and Antibiotic - fixed-extended-duration in people with Complicated Intra-abdominal Infection, run by Lydia Flett at 36 sites in United Kingdom.
Trial summary
A multicentre, open label, two-arm, parallel group, pragmatic, randomised controlled trial with internal pilot. A total of 1166 consenting adult patients with cIAI will be recruited and randomised on a 1:1 basis between 28-days antibiotics and standard care antibiotics. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Complicated Intra-abdominal Infection
- What is being tested?
- Antibiotic - standard duration and Antibiotic - fixed-extended-duration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,166 participants
- Where
- 36 sitesUnited Kingdom
- Study dates
- 10 Oct 2022to 31 Jul 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Adults (≥ 16 years) with cIAI* (see cIAI definition)
- 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.
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- 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.
Who cannot join
- Perforated gastric ulcer or duodenal ulcer treated within 24 hours of the onset of symptoms.
- 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
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- 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
- A maximum of 20% of participants entering the trial can have a source of cIAI as the appendix. If 230 patients with appendix as the source are recruited, this will become an exclusion criteria for subsequent patients.
- Note: There are absolute exclusions that preclude trial participation. These include: C. difficile infection, Infected necrotic pancreatitis, Concomitant infection requiring ≥4 weeks antibiotic therapy, Treatment with Interleukin-6 Inhibitors, High likelihood of death within 72 hours of randomisation, Limitations in treatment decided before inclusion, Peritoneal dialysis, Previously recruited for the EXTEND trial, Patient with persistent cIAI of more than 6 months duration and a patient with persistent cIAI of more than 6 months duration. If a patient has two intraabdominal infections, the presence of one of the following ineligible infections does not make a patient ineligible if the other cIAI is eligible: Perforated gastric ulcer or duodenal ulcer treated within 24 hours of the onset of symptoms, Traumatic injury to the bowel (including iatrogenic or intra-operative) treated within 12 hours of injury, Uncomplicated diverticulitis, Ineligible cases of appendicitis (see exclusion criteria above), Uncomplicated cholecystitis, Ischemic or necrotic intestine without perforation, Uterine perforation following uterine surgery treated within six hours of injury or cIAI with a low risk of complications.
Trial locations and contacts
36 sites in 1 country.
36 sites in 1 country
United Kingdom36 sites
Cwm Taf Morgannwg University Health Board,
Abercynon
NHS Grampian
Aberdeen
Hywel Dda University Health Board
Aberystwyth
Buckinghamshire Healthcare NHS Trust
Aylesbury
UniversityHospitals Birmingham NHS Foundation Trust
Birmingham
Bolton NHS Foundation Trust
Bolton
United Lincolnshire Hospitals NHS Trust - Pilgrim Hospital Boston
Boston
University Hospitals Sussex NHS Foundation Trust
Brighton
North Bristol NHS Trust
Bristol
North Cumbria Integrated Care NHS Foundation Turst
Carlisle
Chesterfield Royal Hospital NHS Foundation Trust
Chesterfield
University Hospital Coventry & Warwickshire
Coventry
County Durham and Darlington NHS Foundation Trust
Darlington
Northern Lincolnshire and Goole NHS Foundation Trust - Grimsby
Grimsby
Hull University Teaching Hospitals NHS Trust
Hull
East Suffolk and North Essex NHS Foundation Trust
Ipswich
Leeds Teaching Hospitals NHS Trust
Leeds
University Hospitals of Leicester NHS Trust
Leicester
Chelsea and Westminster Hospital NHS Foundation Trust
London
Guys and St Thomas' NHS Foundation Trust
London
Imperial College Healthcare NHS Trust
London
King'S College Hospital Nhs Foundation Trust
London
East Cheshire NHS Trust
Macclesfield
Manchester University NHS Foundation Trust
Manchester
Aneurin Bevan University Health Board
Newport
Norfolk and Norwich University Hospitals NHS Foundation Trust
Norwich
Nottingham University Hospital NHS Trust
Nottingham
University Hospitals Plymouth NHS Trust
Plymouth
Lancashire Teaching Hospitals NHS Foundation Trust
Preston
Barking, Havering and Redbridge University Hospitals Nhs Trust
Romford
East Sussex Hospitals NHS Trust
Saint Leonards-on-Sea
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield
North Tees and Hartlepool NHS Foundation Trust
Stockton-on-Tees
Sherwood Forest Hospitals NHS Foundation Trust
Sutton in Ashfield
Royal Cornwall Hospitals NHS Trust
Truro
University Hospitals Sussex NHS Foundation Trust
Worthing
About this study
Official title: The EXTEND Trial: Fixed-extended-duration Antibiotics (28 Days) Compared to Standard Care Antibiotic Durations in Adult Patients With Complicated Intra-abdominal Infection and Their Impact on Treatment Failure
A multicentre, open label, two-arm, parallel group, pragmatic, randomised controlled trial with internal pilot. A total of 1166 consenting adult patients with cIAI will be recruited and randomised on a 1:1 basis between 28-days antibiotics and standard care antibiotics. Patients will be followed up for 180 days to determine cost effectiveness and the rate of treatment failure in each group.
Read the detailed description
UK data suggests that current treatment for complicated intra-abdominal infections (cIAIs) results in unacceptably high rates of cIAI relapse and extra-abdominal infection. As a guiding rule, shorter antibiotic durations are important to combat antimicrobial resistance, but this is not true when these shorter courses need repeating and result in more days in hospital. Optimal care for patients should be our primary concern.
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
- Complicated Intra-abdominal Infection
- Being tested
- Antibiotic - standard duration, Antibiotic - fixed-extended-duration
- Keywords
- infection, antibiotics, antibiotic resistance
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antibiotic - standard durationDrug
Clinician decided antibiotic and duration of treatment
Antibiotic - fixed-extended-durationDrug
Clinician decided antibiotic for a fixed duration of 28 days.
| Study group | Role | What they receive |
|---|---|---|
| Standard care | Active comparator | Clinician decided antibiotic treatment duration Receives: Drug: Antibiotic - standard duration |
| Fixed-extended-duration antibiotics | Experimental | 28 day antibiotic treatment duration Receives: Drug: Antibiotic - fixed-extended-duration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment failure within 180 days of randomisation.
For in-patients, treatment failure is defined when a patient meets objective criteria for both inflammation and infection within a 5 day period. Meeting of the criteria for inflammation may precede or follow the date that criteria for infection were met (the first day of an eligible antibiotic treatment course). These criteria are:
Criteria for Inflammation
- A fever (≥ 37.8 degrees Celsius) or hypothermia (≤36 degrees Celsius), plus
- A neutrophilia (>7.5 x109/L) or neutropaenia (<1.8 x 109/L), plus
- A CRP over 100 mg/L
PLUS, criteria for infection
- Initiation of a new antibiotic treatment course of ≥ 5 days, or
- A change in antibiotic treatment continued for ≥ 5 days, or
- Initiation of a new antibiotic treatment, or a change in antibiotic treatment, and death within 5 days.
- Bacteraemia with a recognised intestinal pathogen include: Anaerobes (e.g., Bacteroides), Enterobacterales and Streptococcus species.
Assessed by blinded outcome committee
Measured: 180 days
Secondary outcomes (15)
Quality of life (EQ-5D-5L)
Participants will complete the EQ-5D-5L at baseline, and at 30, 90 and 180 days post-randomisation.
Measured: 180 days
Cost effectiveness
Participants will complete health care resource use questionnaires at 30, 90 and 180 days after randomisation to record activity outside of hospital. Research teams will record data related to expenses as an inpatient.
Measured: 180 days
Desirability Of Outcome Ranking (DOOR)
Patients will be categorised according to the worst outcome they experience over the 6 months follow up period using a four-level ordinal classification the Desirability Of Outcome Ranking (DOOR). The four levels will be C1 = No treatment failure, C2 = Treatment failure (as for the primary outcome), C3 = Treatment failure associated with sepsis (NEWS 6 in ward-based patients and SOFA 2 in ICU based patients) and C4 = Treatment failure associated with death.
Measured: 180 days
Number and type of source control procedures
The total number and type of source control procedures measured by reviewing patient notes at 180 days after randomisation. The definition of source control used for this study is any procedure that stops the ongoing contamination of the peritoneal cavity and removes the majority of the contaminated intraperitoneal contents to the extent that no further acute interventions are felt to be necessary.
The different types (radiological, surgical) and source control procedures of any type occurring in each randomised group will be compared using a proportional odds model, with fixed effects for allocation, the stratification factors and other prognostic baseline covariates, and random intercepts for study recruitment site.
Measured: 180 days
Relapse of cIAI
The proportion of patients that experience a relapse of cIAI during the 180 days following randomisation will be reported by randomised group.
Measured: 180 days
All-cause mortality
All-cause mortality (time to event) measured by reviewing patient notes at 180 days after randomisation.
Brief summaries of the total time at risk and number/proportion of participants who died will be presented by randomised group and overall
Measured: 180 days
Length of hospital stay
Length of hospital stay measured by reviewing patient notes at 180 days after randomisation. Total number of nights in hospital (with death coded as the worst/highest outcome) will be compared using a proportional odds model, with fixed effects for allocation, the stratification factors and other prognostic baseline covariates, and random intercepts for study recruitment site.
Measured: 180 days
Re-admission
Re-admission measured by reviewing patient notes at 180 days after randomisation.
The proportion of participants who are re-admitted to hospital during the 180 days following randomisation, and number of re-admissions per participant will be reported descriptively by randomised group and overall
Measured: 180 days
C. difficile infection
- difficile infection measured by reviewing patient notes at 180 days after randomisation.
The proportion of patients that experience C. difficile infection during the 180 days following randomisation will be reported by randomised group.
Measured: 180 days
Anti-microbial resistant (AMR) infections
Anti-microbial resistant (AMR) infections measured by reviewing patient notes at 180 days after randomisation. When standard treatment fails in patients with cIAI, antibiotics are often escalated to one of the carbapenem class of antibiotics. We will therefore use rates of carbapenem prescribing as a surrogate for AMR infections.
Participants will undergo passive surveillance for antimicrobial resistant infections (including MRSA, VRE, ESBL and CPE) during the 180 days following randomisation. The proportion of patients that experience each type of antimicrobial infection, number of days receiving carbapenem class antibiotics and the number of antibiotic class switches will be reported descriptively by randomised group and overall.
Measured: 180 days
Days of antibiotic therapy (in-patient and outpatient)
Days of antibiotic therapy (in-patient and outpatient) including anti-fungal therapy measured by reviewing patient notes and from a questionnaire completed by patients at 180 days after randomisation.
The total number of days of anti-microbial therapy (inpatient, outpatient and overall) during the 180 days following randomisation, proportion of total follow up time on anti-microbial therapy, and mortality will be reported descriptively by randomised group and overall.
Measured: 180 days
Acute kidney injury
Acute kidney injury measured by reviewing patient notes at 180 days after randomisation and defined as: an increase in serum creatinine by ≥ 0.3 mg/dl (≥ 26.5 µmol/l) within 48 hours; or increase in serum creatinine to ≥ 1.5 times baseline, which is known or presumed to have occurred within the prior 7 days; or urine volume < 0.5 ml/kg/h for 6 hours (KDIGO Clinical Practice Guideline for Acute Kidney Injury).
The proportion of patients that experience acute kidney injury during the 180 days following randomisation will be reported by randomised group.
Measured: 180 days
Complications
Will be measure by reviewing patient notes at 180 days after randomisation.
Measured: 180 days
Number of days on ventilation and days of renal replacement therapy.
Will be measure by reviewing patient notes at 180 days after randomisation.
Measured: 180 days
Time to treatment failure
Time to treatment failure and number of episodes of treatment failure.
Measured: 180 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2021
- Study start10 Oct 2022
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complicated Intra-abdominal InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A phase III multicentre, open label, two-arm, parallel group, pragmatic, randomised controlled trial with internal pilot.
- Masking
- None (open label)
- Enrolment
- 1,166 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lydia Flett
- Sponsor type
- University, hospital or other
- Collaborators
- University of York, University of Birmingham, Chesterfield Royal Hospital NHS Foundation Trust, University of Leeds, The Leeds Teaching Hospitals NHS Trust
- Responsible party
- Sponsor-investigator, Lydia Flett, University of York
- Investigators
- Andrew Kirby, MD, Principal investigator, University of Leeds
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05148702
- Sponsor's protocol ID
- NIHR131784
- Other IDs
- ISRCTN 72819021
- Acronym
- EXTEND
- Status last verified
- Jul 2026
- First submitted
- 19 Nov 2021
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The EXTEND Trial: Fixed-extended-duration Antibiotics (28 Days) Compared to Standard Care Antibiotic Durations in Adult Patients With Complicated Intra-abdominal Infection and Their Impact on Treatment Failure
- ClinicalTrials.gov ID
- NCT05148702
- Acronym / sponsor ID
- EXTEND / NIHR131784
- Conditions
- Complicated Intra-abdominal Infection
- Keywords
- infection, antibiotics, antibiotic resistance
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,166 participants (estimated)
- Lead sponsor
- Lydia FlettUniversity, hospital or other
- Collaborators
- University of York, University of Birmingham, Chesterfield Royal Hospital NHS Foundation Trust, University of Leeds, The Leeds Teaching Hospitals NHS Trust
- Study start
- 10 Oct 2022 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 8 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A multicentre, open label, two-arm, parallel group, pragmatic, randomised controlled trial with internal pilot. A total of 1166 consenting adult patients with cIAI will be recruited and randomised on a 1:1 basis between 28-days antibiotics and standard care antibiotics. Patients will be followed up for 180 days to determine cost effectiveness and the rate of treatment failure in each group.
Detailed description
UK data suggests that current treatment for complicated intra-abdominal infections (cIAIs) results in unacceptably high rates of cIAI relapse and extra-abdominal infection. As a guiding rule, shorter antibiotic durations are important to combat antimicrobial resistance, but this is not true when these shorter courses need repeating and result in more days in hospital. Optimal care for patients should be our primary concern.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A phase III multicentre, open label, two-arm, parallel group, pragmatic, randomised controlled trial with internal pilot.
| Arm | Type | Receives |
|---|---|---|
| Standard care | Active comparator | Drug: Antibiotic - standard durationClinician decided antibiotic treatment duration |
| Fixed-extended-duration antibiotics | Experimental | Drug: Antibiotic - fixed-extended-duration28 day antibiotic treatment duration |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (17 listed)
- Adults (≥ 16 years) with cIAI* (see cIAI definition)
- 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.
Key exclusion criteria (20 listed)
- Perforated gastric ulcer or duodenal ulcer treated within 24 hours of the onset of symptoms.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antibiotic - standard durationClinician decided antibiotic and duration of treatment | Drug | Standard care |
| Antibiotic - fixed-extended-durationClinician decided antibiotic for a fixed duration of 28 days. | Drug | Fixed-extended-duration antibiotics |
Primary outcome
Treatment failure within 180 days of randomisation.
Time frame: 180 days
For in-patients, treatment failure is defined when a patient meets objective criteria for both inflammation and infection within a 5 day period. Meeting of the criteria for inflammation may precede or follow the date that criteria for infection were met (the first day of an eligible antibiotic treatment course). These criteria are: Criteria for Inflammation * A fever (≥ 37.8 degrees Celsius) or hypothermia (≤36 degrees Celsius), plus * A neutrophilia (>7.5 x109/L) or neutropaenia (<1.8 x 109/L), plus * A CRP over 100 mg/L PLUS, criteria for infection * Initiation of a new antibiotic treatment course of ≥ 5 days, or * A change in antibiotic treatment continued for ≥ 5 days, or * Initiation of a new antibiotic treatment, or a change in antibiotic treatment, and death within 5 days. * Bacteraemia with a recognised intestinal pathogen include: Anaerobes (e.g., Bacteroides), Enterobacterales and Streptococcus species. Assessed by blinded outcome committee
15 secondary outcomes
Quality of life (EQ-5D-5L)
Time frame: 180 days
Cost effectiveness
Time frame: 180 days
Desirability Of Outcome Ranking (DOOR)
Time frame: 180 days
Number and type of source control procedures
Time frame: 180 days
Relapse of cIAI
Time frame: 180 days
All-cause mortality
Time frame: 180 days
Length of hospital stay
Time frame: 180 days
Re-admission
Time frame: 180 days
C. difficile infection
Time frame: 180 days
Anti-microbial resistant (AMR) infections
Time frame: 180 days
Days of antibiotic therapy (in-patient and outpatient)
Time frame: 180 days
Acute kidney injury
Time frame: 180 days
Complications
Time frame: 180 days
Number of days on ventilation and days of renal replacement therapy.
Time frame: 180 days
Time to treatment failure
Time frame: 180 days.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Trial websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Kirby, MD principal investigator
University of Leeds
36 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Antibiotic - standard duration and Antibiotic - fixed-extended-duration in people with Complicated Intra-abdominal Infection, run by Lydia Flett at 36 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment failure within 180 days of randomisation. (time frame: 180 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.