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    Summary
    EudraCT Number:2012-000942-36
    Sponsor's Protocol Code Number:POWAR
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-10-25
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2012-000942-36
    A.3Full title of the trial
    Are phrophylactic antibiotics necessary before laparoscopic living kidney donation? A double blind, randomised, controlled trial.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A randomised trial of antibiotic therapy to prevent infections after kidney donation
    A.3.2Name or abbreviated title of the trial where available
    POWAR study (Prophylaxis of wound infections - Antibiotics in Renal donation)
    A.4.1Sponsor's protocol code numberPOWAR
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorGuys and St Thomas NHS Foundation Trust
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportNIHR
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGuy's & St Thomas' NHS Foundation Trust
    B.5.2Functional name of contact pointNizam Mamode
    B.5.3 Address:
    B.5.3.1Street AddressRenal Offices, 6th Floor, Borough Wing, Guys Hospital
    B.5.3.2Town/ cityGreat Maze Pond, London
    B.5.3.3Post codeSE19RT
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number02071888476
    B.5.5Fax number02071885646
    B.5.6E-mailnizam.mamode@gstt.nhs.uk
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameco-amoxiclav
    D.3.4Pharmaceutical form Powder for solution for injection or infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCLAVULANIC ACID
    D.3.9.1CAS number 58001-44-8
    D.3.9.4EV Substance CodeSUB06642MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAMOXICILLIN SODIUM
    D.3.9.1CAS number 34642-77-8
    D.3.9.4EV Substance CodeSUB00503MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboInjection
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Post-operative infections
    E.1.1.1Medical condition in easily understood language
    Post-operative infections
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10059428
    E.1.2Term Postoperative infection
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main 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.
    E.2.2Secondary 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.
    E.2.3Trial contains a sub-study No
    E.3Principal 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.
    E.4Principal 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.
    E.5 End points
    E.5.1Primary 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
    E.5.1.1Timepoint(s) of evaluation of this end point
    30 days after surgery
    E.5.2Secondary 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.
    E.5.2.1Timepoint(s) of evaluation of this end point
    30 days after surgery
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial 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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months8
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 400
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 400
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state400
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    The intervention is a single dose of antibiotic or placebo, so continued provision is not necessary. Routine annual follow up is normally offered to all those having a donor nephrectomy.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-10-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-10-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-07-12
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