A randomised trial of antibiotic therapy to prevent infections after kidney donatio

Phase 1

• Conditions: Post-operative infections; MedDRA version: 14.1 Level: LLT Classification code 10059428 Term: Postoperative infection System Organ Class: 100000004862; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2012-000942-36-GB
• Lead Sponsor: Guys and St Thomas NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-10-25
• Study Completion: 2016-07-12
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 295

Inclusion Criteria

All adult patients (over 18 years) undergoing hand-assisted laparoscopic donor nephrectomy, who have given written informed consent, will be included.
Patients whose first language is not English will be included; they comprise a significant part of our patient population and we will use translation services as is our normal practice.
Women of child-bearing age taking adequate contraception (oral contraceptive pill or depot injections) will be included.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 400
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 400

Exclusion Criteria

Patients with a known allergy to penicillin or other antibiotics.
Patients with MRSA colonisation.
Participation in another investigational study within the previous 90 days.
Pregnant or breast-feeding women.
Patients who have insufficient understanding of the trial.
•Patients who have Hypersensitivity to the active substances, to any of the penicillins or to any of the excipients.
•Patients who have a History of a severe immediate hypersensitivity reaction (e.g. anaphylaxis) to another ß-lactam agent (e.g. a cephalosporin, carbapenem or monobactam).
•Patients who have a History of jaundice/hepatic impairment due to amoxicillin/clavulanic acid.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified