Asymptomatic Bacteriuria & Risk of Urinary Tract Infection in Renal Transplants

NCT01349738 | Unknown DMC

• 1 other identifier: ASB in Transplants
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bacteriuria; Urinary Tract Infections; Asymptomatic Infections; Transplantation Infection

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Host Characteristics of Renal Transplant Patients with Asymptomatic Bacteriuria at Risk to Develop Symptomatic Urinary Tract Infection

  2 years

• Determine the characteristics of uropathogenic bacteria that cause acute allograft injury in renal transplant patients.

  2 years

Study Arms (2)

Positive Group

Positive for ASB

Drug: Antibiotic

Negative Group

Negative for ASB

Interventions

Antibiotic DRUG

Antibiotic (drug) sensitive to most recent culture for these subjects testing ASB positive and also experience Signs and symptoms of a UTI

Also known as: Trimethoprim sulfamethoxazole (Bactrim), Levofloxacin (Levaquin), Ampicillin, SUSCEPTIBILITY, Organism >100,000 col/ml Escherichia coli (presumptive), Susceptibility type MIC (BY VITEK 2), Ampicillin >=32 Resistant, Ampicillin/Sulbactam 16 Intermediate, Cefazolin <=4 Suscep., Ciprofloxacin <=0.25 Suscep., Gentamicin <=1 Suscep., Levofloxacin <=0.12 Suscep., Nitrofurantoin <=16 Suscep., Tobramycin <=1 Suscep., Trimeth-Sulfa >=16/304 Resistant

Positive Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Kidney Transplant Patients

You may qualify if:

• must be 18 years old or older,
• had a kidney transplant,
• be at least 30 days post operation.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rice, James C., M.D.: lead
• University of Alabama at Birmingham: collaborator

Study Sites (1)

Scripps Green Hospital

La Jolla, California, 92037, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

The investgators have a repository of bacteria specimens from transplant patients with UTI and plan to save bacteria from this study. The investigators will also plan to save discarded aliquots of supernatent of urine and discarded aliquots of blood, all samples from centrifuged specimens devoid of human cells.

MeSH Terms

Conditions

Bacteriuria; Urinary Tract Infections; Asymptomatic Infections

Interventions

Anti-Bacterial Agents; Trimethoprim, Sulfamethoxazole Drug Combination; Levofloxacin; Ampicillin

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Asymptomatic Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Sulfamethoxazole; Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Sulfanilamides; Aniline Compounds; Amines; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Trimethoprim; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations; Ofloxacin; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Penicillin G; Penicillins; beta-Lactams; Lactams

Study Officials

• James C. Rice, MD

  Scripps

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 4, 2011
• First Posted: May 9, 2011
• Study Start: May 1, 2011
• Study Completion: May 1, 2013
• Last Updated: September 1, 2011

Record last verified: 2011-08

Locations

US (1)