Overview
Sponsor-declared trial summary
Complicated acute appendicitis
To evaluate whether a postoperative therapeutic strategy, Fast Track, aimed at shortening hospital stay in pediatric patients undergoing laparoscopic appendectomy for complicated acute appendicitis, yields outcomes that are not inferior to the standard therapeutic model in terms of the combined variable of adverse even…
Key facts
- Sponsor
- Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau
- Participant type
- Pediatric, Patients
- Age range
- 0-17 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Pathological Conditions, Signs and Symptoms [C23], Analytical,Diagnostic,Therapeutic Techniques and Equipment [E]-Surgical Procedures, Operative [E04], Diseases [C] - Bacterial Infections and Mycoses [C01]
- Trial duration
- 29 Jan 2025 → ongoing
- Decision date (initial)
- 2025-01-29
- Transition trial
- Yes
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2025-520777-39-00
- EudraCT number
- 2020-004460-25
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
To evaluate whether a postoperative therapeutic strategy, Fast Track, aimed at shortening hospital stay in pediatric patients undergoing laparoscopic appendectomy for complicated acute appendicitis, yields outcomes that are not inferior to the standard therapeutic model in terms of the combined variable of adverse events within 30 days postoperatively (including postoperative abdominal abscess, peritonitis, surgical wound complications, reintervention, sepsis, or death).
Secondary objectives 8
- Evaluate individually the incidence of postoperative abdominal abscess, peritonitis, surgical wound complications, reintervention, sepsis, and death.
- Compare hospital readmission rates between both study arms during the first postoperative month following appendectomy.
- Determine changes in procalcitonin levels at 6-10 hours postoperatively in cases of complicated appendicitis and evaluate its application as a criterion for early discharge (only in centers that choose to participate).
- Describe the pathogens causing appendicitis and their antibiotic sensitivity (only in centers that choose to participate).
- Compare patient and family satisfaction between the standard strategy and the Fast Track therapeutic model, using the CSQ-18 questionnaire.
- Evaluate adverse reactions associated with antibiotic treatment.
- Assess the quality of life of patients under the Fast Track therapeutic strategy using the EQ-5D-5Y questionnaire in comparison with the standard strategy.
- Quantify the cost of implementing the Fast Track therapeutic strategy and compare it to the cost of the standard strategy.
Conditions and MedDRA coding
Complicated acute appendicitis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10003008 | Appendectomy | 10042613 |
| 20.0 | PT | 10064736 | Antibiotic prophylaxis | 100000004865 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Age: 2 to 17 years.
- Intraoperative diagnosis of complicated appendicitis.
- Undergoing appendectomy via laparoscopic approach.
- Agreement to participate in the study with signed informed consent.
Exclusion criteria 5
- Patients requiring ICU admission with vasoactive support
- Catarrhal or phlegmonous appendicitis.
- History of cystic fibrosis, Crohn's disease, or transplant that may interfere with the usual postoperative course of laparoscopic appendectomy.
- Contraindication to the administration of amoxicillin-clavulanic acid (allergy or intolerance).
- Refusal to participate in the study by parents/legal guardians.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The primary outcome measure will be the composite variable "adverse events" occurring within the first 30 postoperative days, defined as the occurrence of any of the following events: intra-abdominal abscess, peritonitis, surgical wound complications, reoperation, sepsis, or death.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Amoxicilina/Ácido clavulánico NORMON 875 mg/125 mg comprimidos recubiertos con película EFG
PRD11918358 · Product
- Active substance
- Amoxicillin
- Substance synonyms
- AMOXICILLINE, AMOXICILLINUM
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 70 mg/kg milligram(s)/kilogram
- Max total dose
- 35 mg/kg milligram(s)/kilogram
- Max treatment duration
- 3 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01CR02 — AMOXICILLIN AND ENZYME INHIBITOR
- Marketing authorisation
- 70.188
- MA holder
- LABORATORIOS NORMON, S.A.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comparator 1
PRD11782266 · Product
- Active substance
- Amoxicillin
- Substance synonyms
- AMOXICILLINE, AMOXICILLINUM
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- ORAL
- Max daily dose
- 105 mg/kg milligram(s)/kilogram
- Max total dose
- 35 mg/kg milligram(s)/kilogram
- Max treatment duration
- 5 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01CR02 — AMOXICILLIN AND ENZYME INHIBITOR
- Marketing authorisation
- 66425
- MA holder
- LABORATORIOS NORMON, S.A.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau
- Sponsor organisation
- Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau
- Address
- Calle Sant Quinti 77-79
- City
- Barcelona
- Postcode
- 08041
- Country
- Spain
Scientific contact point
- Organisation
- Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau
- Contact name
- Alejandra Espinosa
Public contact point
- Organisation
- Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau
- Contact name
- Alejandra Espinosa
Locations
1 EU/EEA country · 12 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ongoing, recruiting | 772 | 12 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Spain | 2025-01-29 | 2025-01-29 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 7 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2025-520777-39-00 pub | 4 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements pub | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF 6 years | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF parents pub | 3 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Amoxicilina | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Amoxicilina | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis MS_ 2025-520777-39-00 FP | 4 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-01-22 | Spain | Acceptable with conditions 2025-01-29
|
2025-01-29 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-03-25 | Spain | Acceptable 2026-05-07
|
2026-05-12 |