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

Are phrophylactic antibiotics necessary before laparoscopic living kidney donation? A double blind, randomised, controlled trial. - POWAR study (Prophylaxis of wound infections - Antibiotics in Renal donation)

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-000942-36-GB

Enrollment

400

Registered

2012-10-25

Start date

2012-10-22

Completion date

Unknown

Last updated

2019-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-operative infections MedDRA version: 14.1 Level: LLT Classification code 10059428 Term: Postoperative infection System Organ Class: 100000004862

Interventions

Product Name: co-amoxiclav Pharmaceutical Form: Powder for solution for injection or infusion INN or Proposed INN: CLAVULANIC ACID CAS Number: 58001-44-

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: The principal question is whether a single dose of antibiotic prior to donating a kidney reduces infections within 30 days of surgery.;Secondary Objective: 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.; 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 ;Timepoint(s) of evaluation of this end point: 30 days after surgery	—

Measure

Time frame

Main Objective: The principal question is whether a single dose of antibiotic prior to donating a kidney reduces infections within 30 days of surgery.;Secondary Objective: 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.; 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 ;Timepoint(s) of evaluation of this end point: 30 days after surgery

—

Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: 30 days after surgery;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.	—

Countries

United Kingdom

Contacts

Public ContactNizam Mamode

Guy's & St Thomas' NHS Foundation Trust

nizam.mamode@gstt.nhs.uk02071888476

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026