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NCT02113774 Clinical Trial

The Impact of Antimicrobial Treatment for Asymptomatic Bacteriuria in Renal Transplant Patients

Renal Transplantation Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT02113774
Other study ID # 7687
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received March 23, 2014
Last updated April 14, 2014
Start date April 2014

Study information
Verified date April 2014
Source Rabin Medical Center
Contact n/a
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial Summary

The investigators hypothesize that antibiotic therapy for asymptomatic bacteriuria in renal transplant patients does not have impact on the development of symptomatic urinary tract infection (UTI) or progression of renal impairment in patients during the first year after transplantation.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 0
Est. completion date
Est. primary completion date April 2019
Accepts healthy volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients who are =1 month and = 12 months after renal transplantation.

- Positive urine culture defined as = 105 colony forming units (CFU) per milliliter of a known single pathogen.

Exclusion Criteria:

- Any one of the following signs and symptoms: fever, abdominal pain, dysuria, frequency, urgency, flank pain, costovertebral-angel tenderness or tenderness over the transplanted kidney

- Active infections in another site

- Leucocytosis (WBC >18.000K/micl) or leucopenia (WBC < 3.000 K/micl)

- Elevation of serum creatinine of more than 15% of its baseline level

- Obstructive or other urological complications following transplantation as known foreign device (stent/double-J-Cath, any catheter) in the urinary tract system, known obstruction of the transplanted kidney, indwelling or intermittent catheterization

- Pregnant or lactating women.

- Candidates to invasive urologic procedures.

- Inability to return for regular follow up.

- Previous enrollment in this study.

- Patients who incapable of giving informed consent.

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Other:
• antimicrobial treatment according to in-vitro susceptibility

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Rabin Medical Center

Outcome
Type Measure Description Time frame Safety issue
Other graft loss 1 year
Primary development of symptomatic urinary tract infection 30 days
Secondary 25% reduction in estimated glomerular filtration rate (eGFR) 1 year
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