Oral Antibiotic Outpatient Therapy vs. Placebo in the Treatment of Uncomplicated Acute Appendicitis: a Randomized Double-blind Placebo-controlled Noninferiority Trial APPAC IV

APPAC IV

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.

2024-01-01

2025-12-01

2045-12-01

Not yet recruiting

498

Inclusion Criteria: 1. Signed informed consent 2. Age 18-60 years 3. CT scan confirmed diagnosis of uncomplicated acute appendicitis. Exclusion Criteria: 1. Complicated acute appendicitis on CT (presence of appendicolith, perforation, abscess, suspicion of tumor, or appendiceal diameter ≥ 15 mm), 2. body temperature \> 38°C, 3. age younger than 18 or older than 60 years, 4. 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), 5. severe systemic illness (malignancy, or requiring immunosuppressant medication), and 6. all contraindications and other relevant precautions to moxifloxacin (please see list below) 7. inability to co-operate and give informed consent. Contraindications and other relevant precautions to moxifloxacin in addition to already mentioned trial exclusion criteria: Hypersensitivity to moxifloxacin, or to other quinolones Patients with a history of tendon disease/disorder related to quinolone treatment, Congenital or documented acquired QT prolongation or baseline QTc ≥500 ms, Electrolyte disturbances, particularly in uncorrected hypokalaemia, Clinically relevant bradycardia, Clinically relevant heart failure with reduced left-ventricular ejection fraction, Previous history of symptomatic arrhythmias, Concurrent use of other drugs that prolong the QT interval, * Anti-arrhythmics class IA (e.g. quinidine, hydroquinidine, disopyramide) * Anti-arrhythmics class III (e.g. amiodarone, sotalol, dofetilide, ibutilide) * Antipsychotics (e.g. phenothiazines, pimozide, sertindole, haloperidol, sultopride) * Tricyclic antidepressive agents * Certain antimicrobial agents (saquinavir, sparfloxacin, erythromycin IV, pentamidine, antimalarials particularly halofantrine) * Certain antihistaminics (terfenadine, astemizole, mizolastine) * Others (cisapride, vincamine IV, bepridil, diphemanil).

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'maskingDescription': 'Double blinding. The colored oral capsules for both study groups will have an identical appearance preventing both specific smell and taste; all drugs will be manufactured with identical labelling. Patients randomly assigned to antibiotics will receive oral moxifloxacin 400 mg once daily for seven days. The patients randomly assigned to placebo will receive an identical once daily oral administration and treatment duration of seven days. If the patient is suspected of not responding to the administered treatment based on clinical findings, the patient will undergo laparoscopic appendectomy based on the decision by the surgeon on call and the reasons for proceeding to appendectomy are recorded. Surgical findings and histopathological examination of the removed appendix will be used to confirm the diagnosis.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 498, 'type': 'ESTIMATED'}}

2024-01-18