Condition category
Urological and Genital Diseases
Date applied
22/05/2018
Date assigned
30/05/2018
Last edited
23/05/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Urinary tract infections are frequent complications early after kidney transplantation, and although simple infection control measures may be effective, the use of antimicrobial coated catheters in settings other than transplantation has shown promising results for infection prevention. The aim of this study is to compare the effectiveness of nitrofurazone-coated silicone urinary catheters with non-impregnated silicone urinary catheters at reducing bacteriuria (bacteria in urine) and urinary tract infections in kidney transplant recipients.

Who can participate?
Living donor kidney transplant recipients

What does the study involve?
Participants are randomly allocated to either a nitrofurazone-coated silicone urinary catheter or a non-impregnated silicone urinary catheter. The total duration of treatment was 7 days. Rates of bacteriuria, urinary infection and antimicrobial resistance are measured at the start of the study, and at 7, 14 and 30 days after kidney transplantation.

What are the possible benefits and risks of participating?
The possible benefits are the reduction of bacteriuria and urinary infection after kidney transplantation. The risks to the participants would be discomfort with the use of the bladder catheter, hematuria (blood in urine), and obstruction of the urinary flow.

Where is the study run from?
Hospital do Rim, São Paulo (Brazil)

When is the study starting and how long is it expected to run for?
June 2010 to December 2014

Who is funding the study?
CAPES Scholarship (Brazil)

Who is the main contact?
Dr Fernando Menezes

Trial website

Contact information

Type

Scientific

Primary contact

Dr Fernando Menezes

ORCID ID

Contact details

1048
Portugal Avenue
São Paulo
04559002
Brazil

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

0734/10

Study information

Scientific title

A randomized clinical trial comparing nitrofurazone-coated and uncoated urinary catheters in kidney transplant recipients

Acronym

Study hypothesis

Urinary tract infections (UTI) are the most common bacterial infections in kidney transplant recipients, accounting for significant morbidity and increased costs. The incidence of UTI in kidney transplant recipients ranges from 7% to 43% and occur mainly during the first month after transplantation. Urinary tract infections and asymptomatic bacteriuria have been associated with impaired graft function, frequent, and sometimes unnecessary, antibiotic use and may precede pyelonephritis, with relevant clinical consequences. Thus, prevention of urinary tract infections and asymptomatic bacteriuria, mainly employing standard nosocomial infection prevention measures may have a significant impact after kidney transplantation.

The purpose of this study was to compare the efficacy of Nitrofurazone-coated silicone urinary catheters with non-impregnated silicone urinary catheters in reducing bacteriuria and urinary tract infections in kidney transplant recipients.

Ethics approval

Ethics and Research Committee of the Universidade Federal de São Paulo, 08/12/2010, ref: 0734/10

Study design

Pilot randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Urinary tract infections

Intervention

Participants were randomized one day before kidney transplantation with a computer-generated system in a 1:1 ratio to a 3-way nitrofural-impregnated silicone catheter (StrataNF, Rochester Medical, Stewartville, Minnesota, USA) or a 3-way non-impregnated silicone catheter (Silmag, Silmag Brasil Produtos Médicos, Sorocaba, São Paulo, Brazil). The principal investigator, clinicians, nurses and participants were not masked to the allocated intervention because of the distinctive appearances of each catheter.

All patients were maintained on a triple immunosuppressive regimen (usually tacrolimus, mycophenolic acid and prednisone), with or without induction (antithymocyte globulin). Acute rejection treatment consisted of intravenous corticosteroids bolus for three to five consecutive days, followed by a course of antithymocyte globulin in the case of corticoid resistance. Perioperative Cefazolin was used as surgical prophylaxis for 24 hours after transplantation, and trimethoprim/sulfamethoxazole (80 mg / 400 mg) was maintained daily for six months.

The total duration of treatment was 7 days. The follow-up was 1 year after kidney transplantation.

Intervention type

Device

Phase

Drug names

Primary outcome measure

Asymptomatic bacteriuria rates, urinary infection rates and antimicrobial resistance rates at baseline (transplant day), 7 days, 14 days and 30 days after kidney transplantation

Secondary outcome measures

Incidence of discomfort, etiological agents and urinary sediment at baseline (transplant day), 7 days, 14 days and 30 days after kidney transplantation.

Overall trial start date

01/06/2010

Overall trial end date

31/12/2014

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Patients included were older than 18 years and consecutively undergoing urethral catheterization for kidney transplantation with a living donor from March 2013 to December 2014

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

214 patients

Participant exclusion criteria

1. Patients with asymptomatic bacteriuria or urinary tract infection at baseline
2. Deceased kidney transplant donors
3. Patients with known hypersensitivity to nitrofurantoin
4. Pregnancy
5. Those refusing to sign the informed consent form

Recruitment start date

04/03/2013

Recruitment end date

31/12/2014

Locations

Countries of recruitment

Brazil

Trial participating centre

Hospital do Rim
960, Borges Lagoa Street
São Paulo
04038-002
Brazil

Sponsor information

Organisation

Hospital do Rim

Sponsor details

960 Borges Lagoa Street
São Paulo
04038002
Brazil

Sponsor type

Hospital/treatment centre

Website

www.hrim.com.br

Funders

Funder type

Government

Funder name

CAPES Scholarship (Brazil)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The additional documents will be available. The protocol is not available online. Planned submission of the results to the American Journal of Infection Control in June 2018.

IPD sharing statement
The dataset will be held at the university (Universidade Federal de São Paulo).

Intention to publish date

30/06/2018

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes