Oral Antibiotic Outpatient Therapy vs. Placebo in the Treatment of Uncomplicated Acute Appendicitis

Launched by TURKU UNIVERSITY HOSPITAL · Jan 14, 2024

Keywords

ClinConnect Summary

The APPAC IV clinical trial is investigating whether taking an oral antibiotic called moxifloxacin can effectively treat uncomplicated acute appendicitis without the need for surgery or hospitalization. This study builds on previous research that showed many patients with this condition can be safely treated without undergoing an operation. The goal is to see if this approach can not only improve patient satisfaction but also lower overall healthcare costs and reduce the use of antibiotics.

To participate in this trial, individuals must be aged between 18 and 60 years and have a confirmed diagnosis of uncomplicated acute appendicitis through a CT scan. However, those with more serious conditions, such as complicated appendicitis or certain health issues, won't be eligible. Participants will receive either the antibiotic or a placebo (a non-active treatment) and will not need to stay in the hospital during their treatment. This study is not yet recruiting participants, but it aims to offer a new way to manage a common surgical issue more effectively.

Gender

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Eligibility criteria

• 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).