Optimizing the antibiotic treatment of uncomplicated acute appendicitis - APPAC II
EU CTIS ID: 2024-518984-36-00
What this study is testing
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
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.