Urinary Tract Infection Clinical Trial
Official title:
Fosfomycin-Trometamol in Urinary Tract Infection Prophylaxis After Kidney Transplantation. Randomized Controlled Trial.
Urinary tract infections (UTI) are the most common complications after kidney
transplantation. Most series have reported incidence between 20 to 50% during the first
year. In the most recent report from our center the incidence was 36.6% during the first 6
months after transplantation.
The clinical consequence in the graft survival and the association with immunological
rejection has not been well defined. Nevertheless, the association of UTI with high rate of
hospitalization and their costs are widely recognized. There is paucity of trials, specially
randomized and controlled, comparing antibiotic prophylaxis in this group of patients. In a
recently published metaanalysis Green et al. (Transpl Infect Dis. 2011 Oct;13(5):441-7)
found only 6 clinical trials well designed, the conclusion was that antibiotic prophylaxis
reduced the incidence of UTI and the risk of sepsis. Based in this information, the KDIGO
guidelines in transplantation recommend the prophylaxis for UTI with
sulfamethoxazole-trimethoprim (SMT). Nevertheless, the rate of bacterial resistance to SMT
has been reported above 50% in almost all the series.
Fosfomycin-trometamol (FT) is a wall antibiotic (piruvil-tranferase inhibitor) that has
shown a good bioavailability, especially in the urinary tract. It has shown a wide
antibacterial spectrum, but the important target seems to be enteric bacilli particularly
Escherichia coli (the most prevalent cause of UTI). FT has also shown a very good activity
against E. coli producer of Extended Spectrum Betalactamases. Recently, the rate of these
multi-drug resistant bacteria has increased in our center as evidence of worldwide
distribution. In addition, the rate of FT resistance has been stable during the last years
(<3%). This phenomenon could be explained because of the properties of this antibiotic, the
most important one seems to be related with the unique mechanism of action and the lack to
propagate the mechanisms of resistance at least in E. coli. There is only one clinical trial
(randomized and controlled), which compared FT with placebo in UTI prophylaxis; 317 women
with recurrent UTI (three by year) were included. They found rates of 0.14 and 2.9
episodes/patient/year, respectively (p<0.001). Furthermore, there was no FT resistance
during the follow up.
Our hypothesis is that in the first six months after kidney transplantation, UTI prophylaxis
with FT will show greater efficacy in comparison with SMT. Considering the incidence of UTI
in our center (36.6%) and the rate of UTI in the unique trial of prophylaxis with FT (14%),
65 patients will be needed by group of treatment to demonstrate a difference of 22% in the
incidence of UTI, with a power of 80% and confidence level of 95%. The primary outcome is
the incidence and rate of UTI during the first six months after kidney transplantation. The
secondary outcomes are, the hospitalization rate, antibiotic resistance rate, rejections and
titer and number of de novo donor specific antibodies.
The investigators propose a randomized, double blind, placebo controlled trial to compare FT
with SMT in the efficacy and safety to prevent UTI during the first six months after kidney
transplantation. The investigators will include patients from two tertiary-care transplant
centers. Recruiting and the randomization will be carried out separately by center and
gender (because female patients have a greater risk of UTI). The medical visits will be
scheduled monthly and include general laboratory, urine culture and information gathering
about antibiotic side effects as well as adherence. Rejection rate and the number and titers
of de novo donor specific antibodies (secondary outcome) will be obtained according to the
standard of care of the institutional kidney transplantation follow up. These include kidney
biopsy at days 0 and 90 after transplantation, as well as determination of donor specific
antibodies after sixth months of follow up. Graft biopsy is also performed whenever graft
dysfunction exists in the absence of an identifiable cause (infection, urinary graft
obstruction).
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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