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Compares treatment options for Complicated Intra-abdominal Infection
Official title EXTENDed Antibiotic Durations Compared to Standard Durations for Patients With Complicated Intra-abdominal Infection.
ClinicalTrials.gov ID: NCT05148702
What this study is testing
What is Antibiotic - standard duration?
Antibiotic - standard duration is an investigational medicine, being studied as a potential treatment for complicated intra-abdominal infection.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 16 and older
You may be able to join if
- 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...
You likely can't join if
- 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...
- 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...
- Non-perforated cholecystitis.
- Ischemic or necrotic intestine without perforation
See the full eligibility criteria
- 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...
- 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...
- 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...
- 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...
- 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...
- 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)...
- 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...
- 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)...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Abercynon, United Kingdom
- Aberdeen, United Kingdom
- Aberystwyth, United Kingdom
- Aylesbury, United Kingdom
- Birmingham, United Kingdom
- Bolton, United Kingdom
- Boston, United Kingdom
- Brighton, United Kingdom
- Bristol, United Kingdom
- Carlisle, United Kingdom
- Chesterfield, United Kingdom
- Coventry, United Kingdom
- Darlington, United Kingdom
- Grimsby, United Kingdom
- Hull, United Kingdom
- Ipswich, United Kingdom
- Leeds, United Kingdom
- Leicester, United Kingdom
- London, United Kingdom
- Macclesfield, United Kingdom
+ 13 more site(s).
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 16 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Abercynon, United Kingdom; Aberdeen, United Kingdom; Aberystwyth, United Kingdom; Aylesbury, United Kingdom; Birmingham, United Kingdom; Bolton, United Kingdom and 27 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.