Efficacy of amoxicillin/clavulanic acid after surgical drainage of perianal abscess in the prevention of the development of anal fistula. A randomized, double-blind clinical trial

2024-520193-35-00 Protocol PERIQxA Therapeutic use (Phase IV) Authorised, recruitment pending

Status Authorised, recruitment pending · 1 EU/EEA countries · 1 sites · Protocol PERIQxA

Overview

Sponsor-declared trial summary

Phase Therapeutic use (Phase IV)
Status Authorised, recruitment pending
Participants planned 300
Countries 1
Sites 1

Patients who underwent surgery for their first episode of a perianal abscess.

To determine the efficacy of antibiotic therapy after surgical drainage of the perianal abscess in the development of perianal fistula.

Key facts

Sponsor
Mariano Artes Caselles
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Digestive System Diseases [C06]
Decision date (initial)
2025-01-14
Transition trial
Yes
Low-intervention
Yes
Rare-disease indication
No
Vulnerable population
No

External identifiers

EU CT number
2024-520193-35-00
EudraCT number
2021-003376-14

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Prophylaxis, Efficacy

To determine the efficacy of antibiotic therapy after surgical drainage of the perianal abscess in the development of perianal fistula.

Secondary objectives 4

  1. Identify the time elapsed until the appearance of perianal fistula and its complexity according to the St James classification.
  2. Identify relapses in the follow-up and the need for re-surgery surgery
  3. Assess the impact on the quality of life of these patients.
  4. Evaluate safety and tolerability

Conditions and MedDRA coding

Patients who underwent surgery for their first episode of a perianal abscess.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

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

Exclusion criteria 7

  1. Allergy or intolerance to amoxicillin/clavulanic acid.
  2. Contraindication to the performance of any of the study procedures.
  3. History of previous perianal surgery.
  4. 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) Previous perianal fistula or fistula diagnosed during surgery. b) Complex abscess. c) Marked cellulitis after surgical drainage. d) History of inflammatory bowel disease. e) History of anal cancer. f) Previous trauma or radiotherapy. g) Diabetes mellitus. h) Immunosuppressed: oncology patients, chronic corticosteroid treatment or other immunosuppressants, chronic kidney disease. i) Prosthetic valves. j) Morbid obesity (BMI>40). k) Signs of severe sepsis
  5. Women with positive pregnancy test result or breast-feeding.
  6. Unwillingness or inability to follow the procedures described in the protocol.
  7. Inability to give written informed consent.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. Percentage of patients who develop perianal fistula.

Secondary endpoints 5

  1. Time to onset of fistula (months).
  2. Complexity of the fistula according to the St James´s classification.
  3. Presence of new episode of perianal abscess at follow-up.
  4. Need for scheduled surgery for perianal fistula treatment (number of interventions, time since initial event and technique used).
  5. Quality of life questionnaire after the onset of perianal fistula (QoLAF-Q questionnaire).

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Amoxicilina/Ácido clavulánico Viatris 875 mg/125 mg comprimidos recubiertos con película EFG

PRD10124759 · Product

Active substance
Amoxicillin Trihydrate
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL
Max daily dose
150 mg/Kg milligram(s)/kilogram
Max total dose
1050 mg/Kg milligram(s)/kilogram
Max treatment duration
1 Week(s)
Authorisation status
Authorised
ATC code
J01CR02 — AMOXICILLIN AND ENZYME INHIBITOR
Marketing authorisation
64712
MA holder
VIATRIS PHARMACEUTICALS, S.L.U.
MA country
Spain
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Mariano Artes Caselles

Sponsor organisation
MARIANO ARTES CASELLES
Address
C/ Manuel de Falla, 1. 28222 - Majadahonda 29104445S
City
MADRID
Postcode
28049
Country
Spain

Scientific contact point

Organisation
MARIANO ARTES CASELLES
Contact name
VERÓNICA POLAINO MORENO

Public contact point

Organisation
MARIANO ARTES CASELLES
Contact name
VERÓNICA POLAINO MORENO

Locations

1 EU/EEA country · 1 investigational sites

By country

CountryMS statusPlanned subjectsSites
Spain Authorised, recruitment pending 300 1
Rest of world — 0 —

Investigational sites

Spain

1 site · Authorised, recruitment pending
Fundacion Para La Investigacion Biomedica Del Hospital Universitario Puerta De Hierro Majadahonda
Cirugía General y del Aparato Digestivo, Calle De Joaquin Rodrigo 2, 28222, Majadahonda

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.

TypeTitleVersion
Protocol (for publication) Protocolo V2 2
Protocol (for publication) Protoloco PERIQxA V3 30_09_22 ingles 3
Protocol (for publication) Protoloco V3 PERIQxA 30-09-22 3
Recruitment arrangements (for publication) ESTUDIO PERIQxA criterios inclusion exclusion 1
Subject information and informed consent form (for publication) Hoja informacion al paciente_V2_PERIQxA 2
Summary of Product Characteristics (SmPC) (for publication) FT AMOXICLAV 1
Synopsis of the protocol (for publication) TRIAL SYNOPSIS 1

Application history

3 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2024-12-21 Spain Acceptable
2025-01-14
 2025-01-14
2 SUBSTANTIAL MODIFICATION SM-1 2025-02-24 Spain Acceptable 2025-04-08
3 SUBSTANTIAL MODIFICATION SM-2 2026-01-23 Spain Acceptable 2026-02-10

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