Oral Antibiotic Outpatient Therapy vs. Placebo in the Treatment of Uncomplicated Acute Appendicitis (NCT06210269) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Oral Antibiotic Outpatient Therapy vs. Placebo in the Treatment of Uncomplicated Acute Appendicitis
Finland498 participantsStarted 2024-01
Plain-language summary
APPAC IV, a randomized double-blind multicenter clinical trial comparing once daily oral moxifloxacin with placebo in an outpatient setting 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. This is a direct research continuum to the previous trial triad: APPAC, APPAC II and APPAC III, which have already established that the majority of patients with uncomplicated acute appendicitis can be safely treated without surgery. The APPAC IV trial is based on a novel concept and approach to further optimize the nonoperative treatment of uncomplicated acute appendicitis with a high potential in resulting in major health care cost savings and potentially also in significant reduction of antibiotic use in an extremely common surgical emergency.
Who can participate
Age range18 Years – 60 Years
SexALL
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Inclusion criteria
✓. Signed informed consent
✓. Age 18-60 years
✓. CT scan confirmed diagnosis of uncomplicated acute appendicitis.
Exclusion criteria
✕. Complicated acute appendicitis on CT (presence of appendicolith, perforation, abscess, suspicion of tumor, or appendiceal diameter ≥ 15 mm),
✕. body temperature \> 38°C,
✕. age younger than 18 or older than 60 years,
✕. contraindications for CT (pregnancy, lactation, allergy to contrast media or iodine, renal insufficiency with serum creatinine exceeding upper reference limit, type 2 diabetes and metformin medication),
✕. severe systemic illness (malignancy, or requiring immunosuppressant medication), and
✕. all contraindications and other relevant precautions to moxifloxacin (please see list below)