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Efficacy of non operative treatment with amoxicillin/clavulanic acid versus surgical treatment in acute uncomplicated appendicitis in children: a prospective multicenter randomized controlled non-inferiority trial with cost utility analysis
EU CTIS ID: 2024-519402-12-00
What this study is testing
is to evaluate the non-inferiority in terms of efficacy at one year of the Non Operative Treatment with amoxicillin/clavulanic acid (80mg/kg/day of amoxicillin) IV for a minimum of 24 hours and a maximum of 48 hours with a relay of Amoxicillin/clavulanic acid (80mg/kg/day) PO in 3 doses daily versus Surgical Treatment.
- Therapeutic confirmatory (Phase III)
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
- Age from 5 to <15 years-old
- Diagnosis of first episode of acute uncomplicated appendicitis (abdominal pain, non-septic clinical aspect: good general condition, normal haemodynamic status, normal diuresis evaluated at clinical examination., and ultrasound and biology or CT scan (in cases where the appendix is not visible on ultrasound) confirming the diagnosis: - an increase in the calibre of the appendix, measured at more than 6 mm in diameter and non-compressibility - free fluid, echogenic fat, regional hyperemia - performed in hospital or reviewed by local radiologist investigators if performed outpatient.)
- - Surgery expected within 24 hours after diagnosis
- Parental good understanding of the monitoring French instructions
- Free and informed consent, signed by both holders of parental authority/legal representative, with the accord of the minor patient
- Affiliation to the health insurance plan
You likely can't join if
- Ultrasound or CT scan showing one or several stercoliths, a plastron, an abscess or peritonitis
- Presence of an appendicolith
- situations contraindicating surgery or anesthesia (patient for whom surgery and anesthesia would pose a life-threatening risk)
- patients who have already received antibiotic therapy for acute appendicitis/ongoing immunosuppressive treatment
- Mental state rendering the person giving consent incapable of understanding the trial
- Parents being a relative of the investigator or a relative of someone from the team directly involved in the trial, including assistant doctors, pharmacists, nurses, and trial coordinators
See the full eligibility criteria
- Age from 5 to <15 years-old
- Diagnosis of first episode of acute uncomplicated appendicitis (abdominal pain, non-septic clinical aspect: good general condition, normal haemodynamic status, normal diuresis evaluated at clinical examination., and ultrasound and biology or CT scan (in cases where the appendix is not visible on ultrasound) confirming the diagnosis: - an increase in the calibre of the appendix, measured at more than 6 mm in diameter and non-compressibility - free fluid, echogenic fat, regional hyperemia - performed in hospital or reviewed by local radiologist investigators if performed outpatient.)
- - Surgery expected within 24 hours after diagnosis
- Parental good understanding of the monitoring French instructions
- Free and informed consent, signed by both holders of parental authority/legal representative, with the accord of the minor patient
- Affiliation to the health insurance plan
- Ultrasound or CT scan showing one or several stercoliths, a plastron, an abscess or peritonitis
- Presence of an appendicolith
- situations contraindicating surgery or anesthesia (patient for whom surgery and anesthesia would pose a life-threatening risk)
- patients who have already received antibiotic therapy for acute appendicitis/ongoing immunosuppressive treatment
- Mental state rendering the person giving consent incapable of understanding the trial
- Parents being a relative of the investigator or a relative of someone from the team directly involved in the trial, including assistant doctors, pharmacists, nurses, and trial coordinators
- Simultaneously participation in another research study involving medicinal products
- Non-visualization of the appendix at ultrasound or CT scan
- Known immunodepression, ongoing immunosuppressive treatment, diabetes
- Severe hematologic disorders (such as bone marrow failure, blood clotting disorders)
- o History of proved allergy to Penicillin History of proved allergy to amoxicillin and/or clavulanic acid History of a severe immediate hypersensitivity reaction (e.g. anaphylaxis) to another beta-lactam agent (e.g. a cephalosporin, carbapenem or monobactam). History of jaundice/hepatic impairment due to amoxicillin/clavulanic acid History of allergy to any of the excipients listed in section 6.1 of each SmPC.
- On going antibiotherapy : previous antibiotherapy have to be stopped at least 48h before inclusion
- Parental refusal of research protocol
- Impossibility of home follow-up after discharge from hospital
- Renal insufficiency with creatinine clearance < 30 mL/min
- Pregnancy/ breastfeeding
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, 0-17 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.