Acute AppendicitisPhase 2ALACARTENCT07857252
Patient Choice Between Antibiotics and Appendectomy in Uncomplicated Appendicitis (FRENCH 47 - ALACARTE)
A Phase 2 study testing Shared decision-making, amoxicillin-clavulanate and Appendectomy in people with Acute Appendicitis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The ALACARTE study evaluates a strategy in which patients with acute uncomplicated appendicitis are given the choice between appendectomy and antibiotic therapy alone. The investigators hypothesize that giving patients the choice of treatment could reduce treatment regret without compromising safety, particularly by… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Acute Appendicitis
- What is being tested?
- Shared decision-making, amoxicillin-clavulanate and Appendectomy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 560 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2026to Nov 2029
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18-70 years
- Diagnosis of uncomplicated AA established by the investigator surgeon that relies on clinico-biological suspicion of acute AA confirm by care radiological tests (US and/or CT and/or MRI) including appendix diameter >6.0mm. and without:
- Diffuse peritonitis on clinical exam (i.e., rigid abdomen / four quadrant peritonitis);
- Radiologic findings of:
- Free air ii. Walled off fluid collection concerning for an abscess iii. Significant amounts of intra-abdominal fluid throughout abdomen (i.e.,more than trace fluid) iv. Extent of inflammation or adjacent organ involvement on radiologic, appendicular plastron on radiologic imaging
- Surgery expected within 24 hours after diagnosis
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- Patient able to read and understand the language and content of the study documents and agreeing to adhere to the protocol requirements
- Patient with internet access at home and a valid email address who declares being able to complete an online questionnaire
- Signature of the written informed consent form by the patient
- Affiliation to a French health insurance scheme
Who cannot join
- Appendicolith visible on radiological tests (US and/or CT and/or MRI)
- Appendix diameter >15mm (risk factor of appendicular tumor) visible on radiological tests (US and/or CT and/or MRI)
- Suspicion of a tumor of the appendix on the imaging exam ((US and/or CT and/or MRI) by the radiologist: (mucocele, pseudomyxoma, neuroendocrine tumor, adenocarcinoma of the appendix, another type of tumor…)
- Evidence of severe sepsis or septic shock (e.g., new presumed sepsis-related organ dysfunction, elevated lactate, and/or fluid unresponsive hypotension)
- Severe or uncontrolled comorbidities, such as hepatic cirrhosis, heart failure, acute or chronic kidney failure (estimated glomerular filtration rate <60mL/min), concurrent hemodialysis or peritoneal dialysis, or treatments using indwelling venous catheters, presence of active cancer or a malignant hemopathy, anticoagulant treatments
- Recent (within 90 days) placement of surgical implant (e.g., pacemaker, joint prosthesis, mechanical valve) or indwelling Left Ventricular Assist Device
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- Immunodeficiency (e.g., absolute neutrophil count <500/mm3, chronic immunosuppressive drugs, long term corticosteroids, or known AIDS [CD4 count <200/mm3 or AIDS-defining illness assessed by patient history)
- History of inflammatory bowel disease (Crohn disease, or ulcerative colitis or indeterminate colitis)
- Ongoing antibiotic therapy for another infection
- Abdominal/pelvic surgery in the past month
- Hypersensitivity to Amoxicillin, clavulanic acid and penicillins
- History of severe immediate hypersensitivity reaction (e.g., anaphylaxis) to another beta-lactam (e.g., a cephalosporin, carbapenem, or monobactam).
- History of icterus/liver damage related to amoxicillin/clavulanic acid
- Allergy to any of the excipients listed in section 6.1 of SmPC
- History of AA treated by antibiotics or appendectomy
- Pregnant* or breast-feeding women
- Participation in another interventional study or being in the exclusion period at the end of a previous study.
- Mental or cognitive impairment rendering the patient unable to understand study information or to provide informed consent.
- Patient being a relative of the investigator or of a member of the research team directly involved in the trial (assistant doctors, pharmacists, nurses, or study coordinators).
- Adult under guardianship or deprived of freedom
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Department of digestive and general surgery, APHP Saint-Antoine Hospital City Paris
Paris, 75012
Maxime COLLARD, MD, PhD, +33.6.26.54.86.19, maxime.collard@aphp.fr
Thibault VORON, MD, PhD, +33.6.65.68.83.30, thibault.voron@aphp.fr
About this study
Official title: Shared Decision-making in Uncomplicated Appendicitis: a Pragmatic Randomized Trial Comparing Patient-driven Choice (Antibiotics Only or Appendectomy) With Systematic Appendectomy (FRENCH 47 - ALACARTE Trial)
The ALACARTE study evaluates a strategy in which patients with acute uncomplicated appendicitis are given the choice between appendectomy and antibiotic therapy alone. The investigators hypothesize that giving patients the choice of treatment could reduce treatment regret without compromising safety, particularly by not increasing the risk of complicated appendicitis.Treatment regret will be assessed one year after the randomization. A public health benefit is also anticipated through cost reduction, as antibiotic therapy alone is expected to be less costly than surgery.
Read the detailed description
Appendectomy provides definitive treatment for acute appendicitis. However, antibiotic therapy alone represents an alternative treatment option for patients with acute uncomplicated appendicitis.Patients are centrally randomized in a 1:1 ratio to either the "Patient Preference Treatment" group or the "Systematic Appendectomy" group.In the "Patient Preference Treatment" group, patients receive information through a video, followed by a discussion with the investigator and a reflection period of at least 30 minutes. Patients may then choose between antibiotic therapy alone and appendectomy. Patients who do not make a treatment choice undergo appendectomy.The study is based on the hypothesis that giving patients a choice of treatment could reduce treatment regret without compromising safety, particularly by not increasing the risk of complicated appendicitis.Treatment regret will be assessed one year after the randomization.
- Conditions
- Acute Appendicitis
- Being tested
- Shared decision-making, amoxicillin-clavulanate, Appendectomy
- Keywords
- Acute uncomplicated appendicitis, Appendectomy, Patient preference, Treatment choice, Regret, Antibiotic therapy
- Medical subject headings
- Appendicitis, Patient Preference
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shared decision-makingOther
Participants receive standardized information and are then allowed to choose between antibiotic therapy alone and appendectomy. Patients who do not express a preference undergo appendectomy.
amoxicillin-clavulanateDrug
Also called amoxicillin-clavulanic acid
amoxicillin-clavulanate (PO or IV 1 gx3/day for patients <90 kg or 1 gx4/day for patients ≥90 kg)
AppendectomyProcedure or surgery
Appendectomy
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm : Patient preference treatment | Experimental | Participants receive standardized information and are then allowed to choose between antibiotic therapy alone and appendectomy. Patients who do not express a preference undergo appendectomy. Receives: Other: Shared decision-making; Drug: amoxicillin-clavulanate; Procedure: Appendectomy |
| Control arm : Appendectomy | Active comparator | Participants undergo appendectomy as the standard treatment for acute uncomplicated appendicitis Receives: Procedure: Appendectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Regret about the initial treatment
The presence of regret about the initial treatment will be evaluated through a specific questionnaire completed online by the patient. The question will be: "You were initially treated for your appendicitis (infection of the appendix) either by surgery with removal of the appendix (appendectomy) or by antibiotic therapy alone without surgery initially. Do you regret the treatment you received? YES - NO." The surgeon will be blinded to the answer.
Measured: 12 month after the randomization
Secondary outcomes (10)
Patient's symptom persistence or recurrence
Proportion of patients with at least one symptom persistence or recurrence at 12 months : Symptom persistence defined by participants who report the persistence of significant abdominal pain (≥4 with intensity quantified using the numeric pain rating scale from 0 to 10), the persistence of a perceived or measured fever > 38.0°C, or the persistence of chills.
Measured: at 12 months
Patient's quality of life at 12 months.
Quality of life assessed by the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L). questionnaire using the French value set for scoring heath states and fulfilled by the participants (Responses are recorded on a 5-point scale: 1 = no problems, 2 = slight problems, 3 = moderate problems, 4 = severe problems, and 5 = extreme problems or unable to perform the activity.)
Measured: at 12 months
Regret concerning the treatment received
The regret at 12 months assessed by the validated decisional regret scale. This standardized scale allows quantifying treatment regret by a score ranging from 0 for no regret to 100 for maximum regret.
Measured: at 12 months
Diagnosis of a complicated AA
Complicated AA is defined by a localized or diffuse peritonitis, abscessed appendicitis, necrotized appendicitis or appendicular plastron as determined by the surgeon through intraoperative findings or through clinical examination and abdominal imaging (CT-scan or MRI or abdominal US) in case of non-surgical management.
Measured: within 12 months after randomization
Positive bacteriological examination of intrabdominal fluid harvested during surgery
Measured: during surgery
Overall 12-months morbidity
The occurrence of at least one of the following complication during the 12 months after randomization: site-related infectious complications (defined as incisional infections or organ-space infections [abscesses]), percutaneous drainage procedure, surgical intervention (for complication after appendectomy or appendectomy for recurrent appendicitis after antibiotic), ileus requiring the placement of a nasogastric tube, wound hernia, small bowel obstruction requiring emergency consultation or hospitalization, adverse event related to the known side effects of the administered antibiotic therapy.
Measured: 12 months
Unscheduled medical encounter
by at least one of the following events:
- Unscheduled consultations or readmissions at hospital related to the AA or to its treatment reported by the participant.
- Among patients treated initially by appendectomy: proportion of patient with unscheduled surgical procedures due to delayed complications after appendicitis or appendectomy.
- Among patients treated initially by antibiotics only: proportion of occurrence of appendectomy (with or without appendicitis on the surgical specimen) or unscheduled surgical procedure other than appendectomy due to complications related to the AA.
- Among patients treated initially by antibiotics only: proportion of recurrence or persistent AA proven by pathological examination of the appendix after appendectomy or by an imaging (CT or ultrasound or MRI) in case of nonsurgical management.
Measured: within 12 months after randomization
Diagnosis of an appendicular tumor
Presence of an appendicular tumor (benign or malignant) defined by the anatomopathological diagnosis on the operative specimen of appendectomy.
Measured: within 12 months after randomization
Cost per quality-adjusted life year (QALY) gained
Economic evaluation comparing patients who had the option to select their treatment versus patients who underwent systematic appendectomy. Results will be expressed as cost per QALY gained at 12 months.
Measured: at 12 months
Cost per additional patient without complication
Economic evaluation comparing patients who had the option to select their treatment versus patients who underwent systematic appendectomy. Results will be expressed as cost per additional patient without complication at 12 months.
Measured: at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionNov 2029 (estimated)
- Study completionNov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute AppendicitisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- ALACARTE trial is a prospective multicenter open-label randomized, superiority clinical trial in two parallel arms (1:1 ratio)
- Masking
- None (open label)
- Enrolment
- 560 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maxime COLLARD, Principal investigator, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07857252
- Sponsor's protocol ID
- APHP240913
- Other IDs
- 2025-520783-17-01, 2025
- Acronym
- ALACARTE
- Status last verified
- Sep 2026
- First submitted
- 15 Sep 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided