Status:
NOT_YET_RECRUITING
Oral Antibiotic Outpatient Therapy vs. Placebo in the Treatment of Uncomplicated Acute Appendicitis
Lead Sponsor:
Turku University Hospital
Collaborating Sponsors:
Tampere University Hospital
Oulu University Hospital
Conditions:
Uncomplicated Acute Appendicitis
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief 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 ...
Detailed Description
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 possible treatment option with appendecto...
Eligibility Criteria
Inclusion
- Signed informed consent
- Age 18-60 years
- CT scan confirmed diagnosis of uncomplicated acute appendicitis.
Exclusion
- 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)
- 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).
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2045
Estimated Enrollment :
498 Patients enrolled
Trial Details
Trial ID
NCT06210269
Start Date
January 1 2024
End Date
December 1 2045
Last Update
January 18 2024
Active Locations (9)
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1
Jyväskylä Central Hospital
Jyväskylä, Finland
2
Kuopio University Hospital
Kuopio, Finland
3
Lahti Central Hospital
Lahti, Finland
4
Mikkeli Central Hospital
Mikkeli, Finland