Antibiotic therapy vs. placebo in the treatment of appendicitis

Phase 1

• Conditions: Acute uncomplicated appendicitis; MedDRA version: 20.0Level: LLTClassification code 10000677Term: Acute appendicitisSystem Organ Class: 100000004862; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]

• Registration Number: EUCTR2015-003634-26-FI
• Lead Sponsor: Turku University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-11-24
• Last Update Posted: 23 October 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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 142
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1) Age <18 or > 60 years, 2) Pregnancy or lactating, 3) Allergy to contrast media
or iodine, 4) Renal insufficiency, 5) Allergy or contraindication to antibiotic therapy 6)
Metformine medication, 7) Severe systemic illness (for example malignancy, medical condition
requiring immunosuppressant medications), 8) Complicated acute appendicitis in a CT scan
(appendicolith, perforation, abscess, suspicion of a tumor), 9) Inability to co-operate and give
informed consent.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The aim of the study is to compare antibiotic therapy with placebo in the treatment of uncomplicated acute appendicitis to evaluate the role of antibiotic therapy in the resolution of acute<br>uncomplicated appendicitis.;Secondary Objective: ;Timepoint(s) of evaluation of this end point: 10 days after initiation of the randomized treatment;Primary end point(s): The primary endpoint is the success of the randomized treatment (treatment efficacy). The treatment<br>success is defined as the resolution of acute appendicitis with study treatment resulting in discharge<br>from the hospital without the need for surgical intervention and treatment efficacy evaluated at ten<br>days after initiation of the randomized treatment.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Secondary endpoints include post-intervention<br>complications (Clavien-Dindo classification), late recurrence of acute appendicitis after study<br>treatment defined as clear clinical suspicion of acute appendicitis evaluated at follow-up of one,<br>three, five and ten years, duration of hospital stay, VAS scores, quality of life (QOL, 15D), sick<br>leave and treatment costs.;Timepoint(s) of evaluation of this end point: Secondary endpoints include post-intervention<br>complications (Clavien-Dindo classification), late recurrence of acute appendicitis after study<br>treatment defined as clear clinical suspicion of acute appendicitis evaluated at follow-up of one,<br>three, five and ten years, duration of hospital stay, VAS scores, quality of life (QOL, 15D), sick<br>leave and treatment costs.