Urinary Tract Infections Clinical Trial
Official title:
Asymptomatic Bacteriuria & Risk of Urinary Tract Infection in Renal Transplants
The goal of this research program is to understand the natural history of asymptomatic bacteriuria in the renal transplant patients, to determine if screening for asymptomatic bacteriuria and identification of key host characteristics and virulence factors present on uropathogenic bacteria identifies a sub-population of patients with asymptomatic bacteriuria that are at risk to develop symptomatic urinary tract infection. Ultimately, the knowledge obtained from this study will prevent inappropriate antibiotic use and may identify whether certain bacterial isolates predispose to renal allograft injury. We will test the hypothesis that (i) asymptomatic bacteriuria is common in the renal allograft recipient and (ii) that symptomatic urinary tract infection and renal allograft dysfunction do not occur unless key host susceptibility factors and uropathogenic bacterial virulence factors are present.
Blood samples and urine cultures will be obtained from asymptomatic renal transplant clinic
patients. If the urine culture is positive (> or = 105 cfu/ml), we will determine the host
and bacterial virulence factors associated with asymptomatic bacteriuria (ASB) and compare
these results to transplant patients that develop a symptomatic UTI. The patient's clinical
information, laboratory data and the bacterial isolate responsible for the UTI will be
collected at the time of their clinic visit and subsequently analyzed.
After the first visit (Day 0 after signing consent) blood and urine will be collected,
subjects will be put into either ASB Positive or ASB Negative groups based upon the results
of their urine culture. From that point, those who test into the ASB Negative group will
have an additional urine culture, either by returning to the clinic or by sending a urine
culture mailer kit, and if cultures remain negative, they will be discharged from the study
after reviewing medications, adverse events and completing a urinary tract infection risk
questionnaire.
For those who test into the ASB Positive group, those subjects will be monitored by the
subject returning to the clinic on Day 10-14, at 1 month, 2 month, 3 month and 6 months for
blood and urine collection, review of medications and adverse events, and completing a
urinary tract infection risk questionnaire. Should the subject have symptoms of a UTI, the
subject will be treated with the appropriate antibiotic for which the bacterial isolated
from their urine culture is sensitive. Patients will return to the clinic 10-14 days later
for a repeat urine culture, complete a urinary tract infection risk questionnaire, and have
a repeat urine culture to confirm they are urinary tract infection free. At this point, the
subject will be discharged from the study after reviewing medications and adverse events.
It is predicted that 75% of patients will test into the ASB Negative Group and do not
require antibiotic therapy. We predict that 25% of patients will test into the ASB Positive
Group, but that less than 5% of these patients will ultimately develop a symptomatic UTI and
require antibiotic treatment.
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Observational Model: Case Control, Time Perspective: Prospective
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