Optimizing the antibiotic treatment of uncomplicated acute appendicitis - APPAC II

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Turku University Hospital

Participant type

Patients

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Digestive System Diseases [C06]

Decision date (initial)

2024-11-20

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-518984-36-00

EudraCT number

2015-003633-10

ClinicalTrials.gov

NCT03236961

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Therapy, Safety

APPAC II trial is a multicentre, open-label, non-inferiority randomised controlled trial comparing per oral (p.o.) antibiotic monotherapy with intravenous (i.v.) antibiotic therapy followed by p.o. antibiotics in the treatment of CT-scan confirmed uncomplicated acute appendicitis

Conditions and MedDRA coding

Uncomplicated acute appendicitis

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. The inclusion criteria are: 1) Age 18–60 years, 2) Diagnosis of uncomplicated acute appendicitis confirmed by CT scan defined by the following criteria: appendiceal diameter exceeding 6 mm with thickened and enhancing wall and periappendiceal edema and /or minor fluid collection, and the absence of the criteria of complicated appendicitis. The CT findings will be evaluated using a standardised CT scan report sheet

Exclusion criteria 1

1. The exclusion criteria are: 1) Age under 18 or over 60 years, 2) Pregnancy or lactation, 3) Allergy to contrast media or iodine, 4) Allergy or contraindication to antibiotic therapy, 5) Renal insufficiency or serum creatinine value exceeding the upper reference limit, 6) Type 2 diabetes mellitus and metformine medication, 7) Severe systemic illness (for example malignancy, medical condition requiring immunosuppressant medication), 8) Inability to co-operate and give informed consent, and 9) Complicated acute appendicitis in the CT scan. A radiological diagnosis of complicated acute appendicitis is defined as typical findings of appendicitis with at least one of the following: appendicolith, periappendiceal abscess, perforation, or suspicion of an appendiceal tumor. Contraindications for the use of antibiotics include either allergy to the antibiotic regimen, auxiliary substance of the drug, or interaction with other medications of patient. In the case of quinolones, epilepsy and previously diagnosed tendinitis or tendon rupture related to quinolone treatment are contraindications. With moxifloxacin, additional contraindications are liver failure (also a general contraindication for study enrolment), heart condition (for example prolonged QT-time) and electrolyte imbalance. Other overall contraindications to antibiotic treatment in general including pregnancy or lactation and age under 18 years, do not apply as these patients will not be evaluated for study enrolment based on general exclusion criteria.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary endpoint of the APPAC II trial is defined as the success of the randomised treatment at one-year follow-up (treatment efficacy). Treatment success in both groups 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.

Secondary endpoints 1

1. Secondary endpoints include post-intervention complications (possible postoperative complications classified using the Clavien-Dindo classification), late recurrence (after one year) of acute appendicitis after antibiotic treatment, duration of hospital stay, VAS scores, quality of life (QOL, using for example 5D or 15D validated QOL questionnaire), length of sick leave and treatment costs.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 3

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Turku University Hospital

Sponsor organisation

Turku University Hospital

Address

Kiinamyllynkatu 10

City

Turku

Postcode

20520

Country

Finland

Scientific contact point

Organisation

Turku University Hospital

Contact name

Paulina Salminen

Public contact point

Organisation

Turku University Hospital

Contact name

Paulina Salminen

Locations

1 EU/EEA country · 9 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 9 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications