Urinary Tract Infections Clinical Trial
— ASBOfficial title:
Asymptomatic Bacteriuria & Risk of Urinary Tract Infection in Renal Transplants
Verified date | August 2011 |
Source | Rice, James C., M.D. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Observational |
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.
Status | Enrolling by invitation |
Enrollment | 200 |
Est. completion date | May 2013 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - must be 18 years old or older, - had a kidney transplant, - be at least 30 days post operation. Exclusion Criteria: - Pregnant women, those planning to become pregnant or nursing mothers; - Renal transplant patients less than 30 days post transplant; Use of an indwelling Foley catheter; - Patients without a renal transplant; - Patients having concurrent surgical/wound infection and presumed hematogenous dissemination for the urinary tract. |
Observational Model: Case Control, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | Scripps Green Hospital | La Jolla | California |
Lead Sponsor | Collaborator |
---|---|
Rice, James C., M.D. | University of Alabama at Birmingham |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Prevalence of Asymptomatic Bacteriuria and Risk of Developing Symptomatic Urinary Tract Infections or Renal Allograft Injury in Renal Transplant Patients | Determine the prevalence and natural history of asymptomatic bacteriuria (ASB) and the host factors associated with the development of symptomatic UTI in renal allograft recipients. We will enroll renal transplant recipients, perform urine cultures and follow all patients with ASB to determine the prevalence of ASB and the host characteristics associated with ASB and the development of symptomatic UTI. | 2 years | No |
Secondary | Host Characteristics of Renal Transplant Patients with Asymptomatic Bacteriuria at Risk to Develop Symptomatic Urinary Tract Infection | We will measure blood and urine immunoglobulin and cytokine levels in patients with ASB and symptomatic UTI to determine if these host's immune parameters predict the outcome of ASB, including the development of symptomatic UTI. | 2 years | No |
Secondary | Determine the characteristics of uropathogenic bacteria that cause acute allograft injury in renal transplant patients. | We will determine the expression of key uropathogenic virulence factors, including P fimbriae, Dr adhesins, and mono-mannose-binding type 1 fimbriae, on E. coli isolated from RTPs with ASB to determine if strains that express such virulence factors are more likely to cause symptomatic UTI and AAI, compared to E. coli that do not express these virulence factors. | 2 years | No |
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