Optimizing the antibiotic treatment of uncomplicated acute appendicitis

Optimizing the antibiotic treatment of uncomplicated acute appendicitis: a prospective randomized multicenter study - APPACII

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-003633-10-FI

Enrollment

552

Registered

2015-12-22

Start date

2016-03-03

Completion date

Unknown

Last updated

2024-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uncomplicated acute appendicitis MedDRA version: 20.1 Level: LLT Classification code 10000677 Term: Acute appendicitis System Organ Class: 100000004862

Interventions

Trade Name: Moxifloxacin Pharmaceutical Form: Tablet Trade Name: Levofloxacin Pharmaceutical Form: Tablet Trade Name: Metronidazole Pharmaceutical Form: Tablet Trade Name: Ertapenem Pharmaceutical

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion criteria: 1) Signed informed consent, 2) Age 18 – 60 years, 3) CT scan confirmed diagnosis of uncomplicated acute appendicitis. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 552 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Exclusion criteria: 1) Age 60 years, 2) Pregnancy or lactating, 3) Allergy to contrast media or iodine, 4) Renal insufficiency, 5) Metformine medication, 6) Severe systemic illness (for example malignancy, medical condition requiring immunosuppressant medications), 7) Complicated acute appendicitis in a CT scan (appendicolith, perforation, abscess, suspicion of a tumor), 8) Inability to co-operate and give informed consent.

Design outcomes

Primary

Measure	Time frame
Main Objective: The aim of study is to optimize the antibiotic therapy for uncomplicated acute appendicitis by evaluating the success of treatment in both study groups and by comparing intravenous antibiotic therapy followed by per oral antibiotics with per oral antibiotic monotherapy. . The study hypothesis is that broad-spectrum intravenous antibiotics requiring additional hospital resources are not necessary for the treatment of uncomplicated acute appendicitis and that per oral monotherapy is non-inferior to the combination of intravenous and per oral antibiotic therapy.;Secondary Objective: The secondary aim is to evaluate the results of our randomized APPAC trial in a prospective patient cohort by implementing antibiotic therapy as the first-line treatment for uncomplicated acute appendicitis in clinical practice.;Primary end point(s): The primary endpoint is to estimate the success of the randomized treatment (treatment efficacy). Treatment success is defined as the resolution of acute appendicitis with antibiotic treatment resulting in discharge from the hospital without the need for surgical intervention and no recurrent appendicitis during a follow-up of one-year. In addition the success of treatment will be compared between study groups. ;Timepoint(s) of evaluation of this end point: 1 year	—

Measure

Time frame

Main Objective: The aim of study is to optimize the antibiotic therapy for uncomplicated acute appendicitis by evaluating the success of treatment in both study groups and by comparing intravenous antibiotic therapy followed by per oral antibiotics with per oral antibiotic monotherapy. . The study hypothesis is that broad-spectrum intravenous antibiotics requiring additional hospital resources are not necessary for the treatment of uncomplicated acute appendicitis and that per oral monotherapy is non-inferior to the combination of intravenous and per oral antibiotic therapy.;Secondary Objective: The secondary aim is to evaluate the results of our randomized APPAC trial in a prospective patient cohort by implementing antibiotic therapy as the first-line treatment for uncomplicated acute appendicitis in clinical practice.;Primary end point(s): The primary endpoint is to estimate the success of the randomized treatment (treatment efficacy). Treatment success is defined as the resolution of acute appendicitis with antibiotic treatment resulting in discharge from the hospital without the need for surgical intervention and no recurrent appendicitis during a follow-up of one-year. In addition the success of treatment will be compared between study groups. ;Timepoint(s) of evaluation of this end point: 1 year

—

Secondary

Measure	Time frame
Secondary end point(s): Secondary endpoints include post-intervention complications (Clavien-Dindo classification), late recurrence (after one-year) of acute appendicitis after antibiotic treatment, duration of hospital stay, VAS scores, quality of life (QOL, 15D), sick leave and treatment costs.;Timepoint(s) of evaluation of this end point: 1 year	—

Countries

Finland

Contacts

Public ContactTurku University Hospital

Turku University Hospital

+35823130000

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026