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

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.

Conditions

• Uncomplicated Acute Appendicitis

Interventions

DRUG

Moxifloxacin 400mg

Oral antibiotic

OTHER

Placebo

Oral placebo

Sponsors & Collaborators

• Tampere University Hospital

  collaborator OTHER

• Oulu University Hospital

  collaborator OTHER

• Kuopio University Hospital

  collaborator OTHER

• Pori Central Hospital

  collaborator UNKNOWN

• Jyväskylä Central Hospital

  collaborator OTHER

• Mikkeli Central Hospital

  collaborator OTHER

• Seinajoki Central Hospital

  collaborator OTHER

• Päijänne Tavastia Central Hospital

  collaborator OTHER

• Turku University Hospital

  lead OTHER_GOV

Principal Investigators

• Paulina Salminen, Professor · Turku University Hospital Professor of surgery

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-01-31

Primary Completion

2025-12-31

Completion

2045-12-31

Countries

• Finland

Study Locations