The Sant Pau Research Institute (IR Sant Pau) is leading the new multicenter clinical trial FTAA (Fast Track in Acute Appendicitis), aimed at improving the postoperative management of complicated appendicitis in children. The study proposes an innovative antibiotic treatment strategy that could reduce hospitalization time without compromising the safety or efficacy of the therapeutic approach.
The trial was recently presented at the European Association for Clinical Pharmacology and Therapeutics Congress (EACPT 2025), held in Helsinki, Finland, from June 28 to July 1. This is the first randomized clinical trial in a pediatric population comparing two antibiotic treatment duration strategies following surgery for complicated appendicitis, one of the most common surgical emergencies in childhood.
The project is coordinated by Dr. María José Martínez Zapata from the Clinical Epidemiology and Healthcare Services Research Group at IR Sant Pau, together with Dr. Carlos Leganés, a pediatric surgeon at Hospital Sant Pau. Also participating are Drs. Rosa María Antonijoan and Claudia Erika Delgado-Espinoza from the Clinical Pharmacology Department and Dr. José María Valle from the Pediatrics Department of the same hospital.
In addition to Hospital Sant Pau, the trial involves collaboration with six other leading hospitals: Hospital Sant Joan de Déu and Hospital del Mar in Barcelona, Hospital Germans Trias i Pujol in Badalona, Hospital Joan XXIII in Tarragona, Hospital Clínico Universitario in Santiago de Compostela, and Hospital Universitario Dr. Josep Trueta in Girona. This broad participation will provide representative and nationally applicable results.
The study has received funding from the 2023 Independent Clinical Research call by the Instituto de Salud Carlos III (ICI23/00070) and is supported by the Spanish Clinical Research Network (SCReN), aimed at facilitating clinical trials of interest to the National Health System.
The primary objective of the FTAA trial is to evaluate whether a shorter antibiotic regimen—three days of intravenous antibiotics in the hospital followed by two days of oral outpatient treatment with amoxicillin-clavulanate—is as effective as the standard five-day in-hospital antibiotic treatment in preventing complications within 30 days of surgery. A total of 772 pediatric patients are planned for recruitment.
If the outpatient strategy proves non-inferior, the study could represent a significant change in clinical practice, reducing children’s hospital stays and promoting quicker recovery in the home environment. This optimization of treatment would not only benefit the quality of life for patients and their families but also contribute to greater efficiency in healthcare resource utilization and decreased exposure to risks associated with prolonged hospitalization.
IR Sant Pau thus reaffirms its commitment to clinical research aimed at improving healthcare, especially in high-impact areas such as pediatric surgery and the rational use of antibiotics.
