Clinical trial • Not applicable • Infectious Disease|Gastroenterology|Other
AMOXICILLIN, CLAVULANIC ACID for Complicated acute appendicitis
Not applicable trial of AMOXICILLIN, CLAVULANIC ACID for Complicated acute appendicitis.
Overview
- Trial Therapeutic Area
- Infectious Disease|Gastroenterology|Other
- Trial Disease
- Complicated acute appendicitis
- Trial Stage
- Not applicable
- Drug Modality
- Small molecule
- Paediatric Trial
- Yes
Key dates
- Initial CTIS Submission Date
- 22-01-2025
- First CTIS Authorization Date
- 29-01-2025
Trial design
Randomised, open-label, amoxicilina/ácido clavulánico normon 1.000 mg/200 mg (powder for solution for injection and for infusion) — comparator (product name and dose given); dosing schedule not specified in ctis record. (test product: amoxicilina/ácido clavulánico normon 875 mg/125 mg film-coated tablet — test; dosing schedule not specified.)-controlled Not applicable trial across 12 sites in Spain.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Amoxicilina/Ácido clavulánico NORMON 1.000 mg/200 mg (powder for solution for injection and for infusion) — Comparator (product name and dose given); dosing schedule not specified in CTIS record. (Test product: Amoxicilina/Ácido clavulánico NORMON 875 mg/125 mg film-coated tablet — Test; dosing schedule not specified.)
- Target Sample Size
- 772
- Trial Duration For Participant
- 30
Eligibility
Recruits 772 paediatric patients.
- Vulnerable Population
- Pediatric participants aged 2–17; participation requires signed informed consent. Subject information and informed consent forms are listed for children ("L1_SIS and ICF 6 years") and for parents ("L1_SIS and ICF parents pub"); consent is provided by parents/legal guardians.
Inclusion criteria
- {"criterion_text":"- Age: 2 to 17 years."}
- {"criterion_text":"- Intraoperative diagnosis of complicated appendicitis."}
- {"criterion_text":"- Undergoing appendectomy via laparoscopic approach."}
- {"criterion_text":"- Agreement to participate in the study with signed informed consent."}
Exclusion criteria
- {"criterion_text":"- Patients requiring ICU admission with vasoactive support"}
- {"criterion_text":"- Catarrhal or phlegmonous appendicitis."}
- {"criterion_text":"- History of cystic fibrosis, Crohn's disease, or transplant that may interfere with the usual postoperative course of laparoscopic appendectomy."}
- {"criterion_text":"- Contraindication to the administration of amoxicillin-clavulanic acid (allergy or intolerance)."}
- {"criterion_text":"- Refusal to participate in the study by parents/legal guardians."}
Endpoints
Primary endpoints
- {"endpoint_text":"- 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.","definition_or_measurement_approach":"Composite variable of adverse events within first 30 postoperative days defined as occurrence of any of: intra-abdominal abscess, peritonitis, surgical wound complications, reoperation, sepsis, or death."}
Recruitment
- Planned Sample Size
- 772
- Recruitment Window Months
- 90
- Consent Approach
- Participation requires signed informed consent. Inclusion criteria state 'Agreement to participate in the study with signed informed consent.' Documents listed include subject information and informed consent forms for children (6 years) and parents, indicating age-specific ICFs; consent is provided by parents/legal guardians. No explicit assent process or languages specified in the CTIS record.
Geography
- Total Number Of Sites
- 12
- Total Number Of Participants
- 772
Spain
- Earliest CTIS Part Ii Submission Date
- 22-01-2025
- Latest Decision Or Authorization Date
- 12-05-2026
- Processing Time Days
- 475
- Number Of Sites
- 12
- Number Of Participants
- 772
Sites
- Site Name
- Hospital Royo Villanova
- Department Name
- Pediatric Surgery
- Principal Investigator Name
- Rocío Soledad Gutiérrez
- Principal Investigator Email
- rociogutierrez1@hotmail.com
- Contact Person Name
- Rocío Soledad Gutiérrez
- Contact Person Email
- rociogutierrez1@hotmail.com
- Site Name
- Hospital Universitario Reina Sofia
- Department Name
- Pediatric Surgery
- Principal Investigator Name
- Javier Murcia Pascual
- Principal Investigator Email
- jmurciapascual@gmail.com
- Contact Person Name
- Javier Murcia Pascual
- Contact Person Email
- jmurciapascual@gmail.com
- Site Name
- Hospital Sant Joan De Deu Barcelona
- Department Name
- Pediatric Surgery
- Principal Investigator Name
- Pedro Palazón Bellver
- Principal Investigator Email
- ppalazon@hsjdbcn.es
- Contact Person Name
- Pedro Palazón Bellver
- Contact Person Email
- ppalazon@hsjdbcn.es
- Site Name
- Hospital Universitari Joan XXIII De Tarragona
- Department Name
- Pediatric Surgery
- Principal Investigator Name
- Carlos Pueyo Gil
- Principal Investigator Email
- pueyogil@gmail.com
- Contact Person Name
- Carlos Pueyo Gil
- Contact Person Email
- pueyogil@gmail.com
- Site Name
- Hospital Germans Trias I Pujol
- Department Name
- Pediatric Surgery
- Principal Investigator Name
- Alba Martin Lluis
- Principal Investigator Email
- martin.cirped@gmail.com
- Contact Person Name
- Alba Martin Lluis
- Contact Person Email
- martin.cirped@gmail.com
- Site Name
- Hospital Universitari De Girona Doctor Josep Trueta
- Department Name
- Pediatric Surgery
- Principal Investigator Name
- Enrique Antonio Bordón Cabrera
- Principal Investigator Email
- abordon.girona.ics@gencat.cat
- Contact Person Name
- Enrique Antonio Bordón Cabrera
- Contact Person Email
- abordon.girona.ics@gencat.cat
- Site Name
- Complexo Hospitalario Universitario De Santiago
- Department Name
- Pediatric Surgery
- Principal Investigator Name
- Lorena Míguez Fortes
- Principal Investigator Email
- lorena.maria.miguez.fortes@sergas.es
- Contact Person Name
- Lorena Míguez Fortes
- Contact Person Email
- lorena.maria.miguez.fortes@sergas.es
- Site Name
- Consorci Mar Parc De Salut De Barcelona
- Department Name
- Pediatric Surgery
- Principal Investigator Name
- Estela Membrilla Fernández
- Principal Investigator Email
- recerca@imim.es
- Contact Person Name
- Estela Membrilla Fernández
- Contact Person Email
- recerca@imim.es
- Site Name
- Hospital De La Santa Creu I Sant Pau
- Department Name
- Epidemiología
- Principal Investigator Name
- Mª José Martínez Zapata
- Principal Investigator Email
- mmartinezz@santpau.cat
- Contact Person Name
- Mª José Martínez Zapata
- Contact Person Email
- mmartinezz@santpau.cat
- Site Name
- University Hospital Virgen Del Rocio S.L.
- Department Name
- Pediatric Surgery
- Principal Investigator Name
- Isabel Casal
- Principal Investigator Email
- isabelcasalbe@gmail.com
- Contact Person Name
- Isabel Casal
- Contact Person Email
- isabelcasalbe@gmail.com
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Pediatric Surgery
- Principal Investigator Name
- ROCIO MORANTE VALVERDE
- Principal Investigator Email
- rocio.morante@salud.madrid.org
- Contact Person Name
- ROCIO MORANTE VALVERDE
- Contact Person Email
- rocio.morante@salud.madrid.org
- Site Name
- Hospital Clinico San Carlos
- Department Name
- Pediatric Surgery
- Principal Investigator Name
- LUIS FELIPE ÁVILA RAMÍREZ
- Principal Investigator Email
- lfavila73@gmail.com
- Contact Person Name
- LUIS FELIPE ÁVILA RAMÍREZ
- Contact Person Email
- lfavila73@gmail.com
Sponsor
Primary sponsor
- Full Name
- Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Spain
Investigational products
- Investigational Product Name
- Amoxicilina/Ácido clavulánico NORMON 875 mg/125 mg comprimidos recubiertos con película EFG
- Active Substance
- AMOXICILLIN, CLAVULANIC ACID
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Authorised (marketing authorisation in Spain)
- Maximum Dose
- 70 mg/kg (max daily dose amount as listed)
- Investigational Product Name
- Amoxicilina/Ácido clavulánico NORMON 1.000 mg/200 mg polvo para solución inyectable y para perfusión EFG
- Active Substance
- AMOXICILLIN, CLAVULANIC ACID
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Authorised (marketing authorisation in Spain)
- Maximum Dose
- 105 mg/kg (max daily dose amount as listed)
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