Etiology of appendicitis and effects of antimicrobial treatment

Phase 1

• Conditions: Acute appendicitis; MedDRA version: 19.1Level: LLTClassification code 10000677Term: Acute appendicitisSystem Organ Class: 100000004862; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]

• Registration Number: EUCTR2016-003655-29-FI
• Lead Sponsor: Turku University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-12
• Last Update Posted: 3 July 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 or complicated acute appendicitis
(appendicolith, perforation, abscess, suspicion of a tumor).
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 200
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

MAPPAC exclusion criteria follow APPAC II and III criteria: 1) Age <18 or > 60 years, 2) Pregnancy or lactating, 3) Allergy to contrast media or iodine, 4) Allergy or
contraindication to antibiotic therapy 5) Renal insufficiency, 6) Metformine medication, 7) Severe systemic illness (for
example malignancy, medical condition requiring immunosuppressant medications), 8) Inability to co-operate and give
informed consent.

Study & Design

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