Selective decontamination of the digestive tract in preventing surgical site infections in elective colorectal surgery: a randomised controlled trial (SELDDEC Trial)

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

Overview

Sponsor-declared trial summary

Phase Therapeutic exploratory (Phase II)

Status Authorised, recruitment pending

Participants planned 322

Countries 1

Sites 1

Surgical site infection

To determine if preoperative oral antibiotics, in the absence of mechanical bowel preparation, reduces the incidence of surgical site infection in elective colorectal surgery

Key facts

Sponsor: University Hospital Limerick
Participant type: Patients
Age range: 18-64 years, 65+ years
Gender: Male and Female
Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Decision date (initial): 2025-01-30
Transition trial: Yes
Low-intervention: No
Rare-disease indication: No
Vulnerable population: No
Funding sources: None

External identifiers

EU CT number: 2025-520725-20-00
EudraCT number: 2017-003670-14

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Prophylaxis

To determine if preoperative oral antibiotics, in the absence of mechanical bowel preparation, reduces the incidence of surgical site infection in elective colorectal surgery

Secondary objectives 1

To determine if preoperative oral antibiotics reduce the incidence of secondary infectious events and surgical complications

Conditions and MedDRA coding

Surgical site infection

Version	Level	Code	Term	System organ class
20.0	LLT	10078408	Surgical site infection	10021881

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

Adult patients (aged ≥ 18 years) scheduled for elective laparoscopic, open and/or robotic assisted colon or rectal surgery for benign or malignant disease

Exclusion criteria 1

1) inability to provide informed consent (2) acute surgery for bleeding, perforation or obstruction, (3) uncontrolled diabetes mellitus, (4) preoperative steroid use, (5) antibiotic use within 2 weeks of proposed elective surgery date and (6) previous allergic reaction to the antibiotics utilised in this study. (7) Patients with contraindications to neomycin and erythromycin. (8) Patients with renal and hepatic impairment. (9) Patients who have a positive pregnancy test. (10) Patients requiring more extensive antibiotic prophylaxis.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

Incidence of surgical site infection

Secondary endpoints 1

Infectious complications other than surgical site infections, length of hospital stay, postoperative complications as per Clavien Dindo Classification, anastomotic leakage and mortality

Investigational products

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

Test 2

Erythromycin Tablets BP 250mg

PRD908215 · Product

Active substance: Erythromycin
Pharmaceutical form: TABLET
Route of administration: ORAL
Max daily dose: 1 g gram(s)
Max total dose: 1 g gram(s)
Max treatment duration: 1 Day(s)
Authorisation status: Authorised
ATC code: J01FA01 — ERYTHROMYCIN
Marketing authorisation: PL 40147/0036
MA holder: ENNOGEN PHARMA LIMITED
MA country: United Kingdom
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Neomycin 500mg Tablets

PRD11094366 · Product

Active substance: Neomycin Sulphate Ph. Eur.
Pharmaceutical form: TABLET
Route of administration: ORAL
Max daily dose: 1 g gram(s)
Max total dose: 1 g gram(s)
Max treatment duration: 1 Day(s)
Authorisation status: Authorised
ATC code: A07AA01 — NEOMYCIN
Marketing authorisation: PL 20072/0223
MA holder: AMDIPHARM UK LIMITED
MA country: XI
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

University Hospital Limerick

Sponsor organisation: University Hospital Limerick
Address: Saint Nessan's Road
City: Limerick
Postcode: V94 F858
Country: Ireland

Scientific contact point

Organisation: University Hospital Limerick
Contact name: Colin Peirce

Public contact point

Organisation: University Hospital Limerick
Contact name: Colin Peirce

Locations

1 EU/EEA country · 1 investigational sites

By country

Country	MS status	Planned subjects	Sites
Ireland	Authorised, recruitment pending	322	1
Rest of world	—	0	—

Investigational sites

Ireland

1 site · Authorised, recruitment pending

University Hospital Limerick

General and Colorectal Surgery, Saint Nessan's Road, V94 F858, Limerick

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 6 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Type	Title	Version
Protocol (for publication)	SELDDEC Trial Protocol CTD	1
Recruitment arrangements (for publication)	Recruitment arrangements	1
Subject information and informed consent form (for publication)	SELDDEC Consent	1
Summary of Product Characteristics (SmPC) (for publication)	Erythromycin Summary of Product Characteristics	1
Summary of Product Characteristics (SmPC) (for publication)	Neomycin Summary of Product Characteristics	1
Synopsis of the protocol (for publication)	SELDDEC Protocol Synopsis	1

Application history

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

#	Type	Code	Submitted	Reference MS	Conclusion	Decision date
1	INITIAL	IN	2025-01-28	Ireland	Acceptable with conditions 2025-01-30	2025-01-30
2	SUBSTANTIAL MODIFICATION	SM-1	2025-04-15	Ireland	Acceptable 2025-05-07	2025-05-07