Project description
Assessing the role of antibiotics in treating uncomplicated appendicitis
Acute appendicitis is a common surgical emergency. Recent trials indicate that antibiotics may serve as a safe and effective alternative. However, the appropriate role of antibiotics in this context requires further clarification. With this in mind, the ERC-funded APPAC IV project constitutes a clinical double-blind trial comparing oral moxifloxacin with placebo aimed at assessing both whether antibiotics are needed in treating uncomplicated appendicitis and if outpatient treatment is feasible. The project will also investigate the effects of antibiotics on gut microbiota and gut health, and their correlation with serum cytokines. Moreover, it will evaluate the development of antibiotic resistance and underlying bacterial defence mechanisms in E. coli and the microbiome.
Objective
Acute appendicitis is one of the most common surgical emergencies worldwide. For over a century, surgical removal of the appendix has been considered the only treatment option. Landmark trials by our experienced APPAC team have shown that imaging confirmed uncomplicated acute appendicitis is not a surgical emergency defining antibiotics to safe and effective also with only oral antibiotics avoiding unnecessary surgeries resulting in major cost and resource savings. However, the role of antibiotics remains a major knowledge gap. Our pilot APPAC III showed that even symptomatic treatment (placebo) may be sufficient warranting a larger noninferiority trial to assess whether antibiotics are needed in the treatment of uncomplicated acute appendicitis.
APPAC IV is a randomized double-blind multicenter clinical trial comparing oral moxifloxacin with placebo in an outpatient setting. APPAC IV aims to evaluate whether antibiotics and hospitalization or both can be omitted in the treatment of uncomplicated appendicitis further significantly increasing cost savings and patient satisfaction; almost 2/3 of all appendectomies (approx. 550.000 operations in Europe), the associated hospital stays, and potentially also antibiotics could be avoided.
The growing global health issue of antibiotic resistance threatens effective prevention and treatment of infections. Studies on rational use of antibiotics are warranted and especially in the changing treatment paradigm of such a common disease. The translational MAPPAC II (Microbiology APPAC) substudy includes serum, rectal and fecal samples of the APPAC IV trial patients pre- and post-therapy. The effects of antibiotics on gut microbiota, gut health and correlation to serum cytokines are evaluated in this unique real-life randomized patient cohort. The development of antibiotic resistance and the underlying bacterial defence mechanisms will be evaluated in E. coli and microbiome using microbial single-cell technologies and metagenomics.
Fields of science (EuroSciVoc)
CORDIS classifies projects with EuroSciVoc, a multilingual taxonomy of fields of science, through a semi-automatic process based on NLP techniques.
CORDIS classifies projects with EuroSciVoc, a multilingual taxonomy of fields of science, through a semi-automatic process based on NLP techniques.
- medical and health sciencesclinical medicinesurgery
- medical and health sciencesbasic medicinepharmacology and pharmacypharmaceutical drugsantibiotics
- natural sciencesbiological sciencesmicrobiology
- medical and health sciencesbasic medicinepharmacology and pharmacydrug resistanceantibiotic resistance
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Keywords
Programme(s)
- HORIZON.1.1 - European Research Council (ERC) Main Programme
Funding Scheme
HORIZON-ERC - HORIZON ERC GrantsHost institution
20014 Turku
Finland