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Active Not Recruiting
NCT05148702
EXTENDed Antibiotic Durations Compared to Standard Durations for Patients With Complicated Intra-abdominal Infection.
Conditions: Complicated Intra-abdominal Infection
Sex: All
Ages: 16 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 1166
Sponsor: Lydia Flett
Location: Cwm Taf Morgannwg University Health Board, Abercynon
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. Patients will be followed up for 180 days to determine cost effectiveness and the rate of treatment failure in each group.
Eligibility Criteria
Inclusion 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 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 (\
Source: ClinicalTrials.gov (NCT05148702). StuddyBuddy aggregates publicly available trial information.