E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Post-operative infections |
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E.1.1.1 | Medical condition in easily understood language |
Post-operative infections |
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E.1.1.2 | Therapeutic area | Diseases [C] - Bacterial Infections and Mycoses [C01] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10059428 |
E.1.2 | Term | Postoperative infection |
E.1.2 | System Organ Class | 100000004862 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The principal question is whether a single dose of antibiotic prior to donating a kidney reduces infections within 30 days of surgery. |
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E.2.2 | Secondary objectives of the trial |
The secondary questions are whether a single dose of antibiotic affects wound healing, length of stay in hospital, readmissions to hospital, antibiotic associated side effects, return to work, quality of life and total healthcare costs. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.
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E.4 | Principal 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 β-lactam agent (e.g. a cephalosporin, carbapenem or monobactam).
• Patients who have a History of jaundice/hepatic impairment due to amoxicillin/clavulanic acid.
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary outcome measure will be a composite endpoint of any infection; this will include surgical site infections as well as urinary tract, respiratory, C. diff associated diarrhoea and any other infections, within 30 days of surgery.
Specifically, the primary endpoint will be defined as the occurrence of any of the following:
1) Purulent drainage from the incision site, confirmed on microbiological testing (significant bacterial growth and pus cells present)
2) Positive culture of any fluid aspirated from the surgical site.
3) At least two of the following at the incision site: fever, pain, swelling, redness, heat and either the wound is opened by the surgeon or the clinician diagnoses an infection.
4) Dehiscence of the surgical wound
5) Evidence of deep infection at reoperation or radiologically.
6) Symptomatic urinary tract infection (dysuria, supra pubic discomfort and/or fever) with a culture positive MSU including pyuria
7) Symptomatic respiratory tract infection (fever, productive cough, dyspnoea) with either a positive culture, radiographical evidence of consolidation or the clinician diagnoses an infection.
8) Any other infection confirmed on microbiological testing
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Secondary endpoints will include ultrasonic evidence of wound healing, length of hospital stay, readmission rates, antibiotic associated side effects (including diarrhoea and allergic reactions), return to work and normal activities, quality of life and relative costs. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 8 |