Amoxicillin trihydrate; Potassium clavulanate for Perianal abscess | Anal fistula

Inclusion criteria

• {"criterion_text":"- Male or female adult patients of at least 18 years of age."}
• {"criterion_text":"- First episode of perianal abscess."}
• {"criterion_text":"- Oral feeding."}
• {"criterion_text":"- Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests and other study procedures."}
• {"criterion_text":"- Signed written informed consent in accordance with ICH/GCP and local legislation, obtained prior to any study procedure."}

Exclusion criteria

• {"criterion_text":"- Allergy or intolerance to amoxicillin/clavulanic acid."}
• {"criterion_text":"- Contraindication to the performance of any of the study procedures."}
• {"criterion_text":"- History of previous perianal surgery."}
• {"criterion_text":"- Any clinical condition, and/or analytical alteration that, in the opinion of the investigator, is considered clinically significant enough to participate in the study. The following are considered as such: a)\tPrevious perianal fistula or fistula diagnosed during surgery. b)\tComplex abscess. c)\tMarked cellulitis after surgical drainage. d)\tHistory of inflammatory bowel disease. e)\tHistory of anal cancer. f)\tPrevious trauma or radiotherapy. g)\tDiabetes mellitus. h)\tImmunosuppressed: oncology patients, chronic corticosteroid treatment or other immunosuppressants, chronic kidney disease. i)\tProsthetic valves. j)\tMorbid obesity (BMI>40). k)\tSigns of severe sepsis"}
• {"criterion_text":"- Women with positive pregnancy test result or breast-feeding."}
• {"criterion_text":"- Unwillingness or inability to follow the procedures described in the protocol."}
• {"criterion_text":"- Inability to give written informed consent."}

Primary endpoints

• {"endpoint_text":"- Percentage of patients who develop perianal fistula.","definition_or_measurement_approach":""}

Secondary endpoints

• {"endpoint_text":"- Time to onset of fistula (months).","definition_or_measurement_approach":"Time measured in months from index event to fistula onset."}
• {"endpoint_text":"- Complexity of the fistula according to the St James´s classification.","definition_or_measurement_approach":"Assessed according to the St James classification (imaging assessment referenced in translations)."}
• {"endpoint_text":"- Presence of new episode of perianal abscess at follow-up.","definition_or_measurement_approach":""}
• {"endpoint_text":"- Need for scheduled surgery for perianal fistula treatment (number of interventions, time since initial event and technique used).","definition_or_measurement_approach":"Captured as number of interventions, time since initial event and surgical technique used."}
• {"endpoint_text":"- Quality of life questionnaire after the onset of perianal fistula (QoLAF-Q questionnaire).","definition_or_measurement_approach":"Measured using the QoLAF-Q questionnaire."}

Spain

Earliest CTIS Part Ii Submission Date

13-01-2025

Latest Decision Or Authorization Date

10-02-2026

Processing Time Days

393

Number Of Sites

1

Number Of Participants

300

Primary sponsor

Full Name

MARIANO ARTES CASELLES

Organisation Type

Health care

Country Of Registered Address

Spain