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

• Sponsor: Rabin Medical Center (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02113774
• Collaborator: (none)
• Arms: 2

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Urinary Tract Infection; Bacteriuria; Renal Transplantation	Other: antimicrobial treatment according to in-vitro susceptibility	Phase 4

Study Design

• Study Type: Interventional
• Primary Purpose: Treatment
• Study Start Date: Apr 1, 2014
• Anticipated Primary Completion Date: Apr 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: no therapy
Active Comparator: antimicrobial treatment according to in-vitro susceptibility	Other: antimicrobial treatment according to in-vitro susceptibility

Outcome Measures

Primary Outcome Measures

1. development of symptomatic urinary tract infection [30 days]

Secondary Outcome Measures

1. 25% reduction in estimated glomerular filtration rate (eGFR) [1 year]

Other Outcome Measures

1. graft loss [1 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Rabin Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ruth Rahamimov, head of transplant investigator service, Rabin Medical Center
• ClinicalTrials.gov Identifier: NCT02113774
• Other Study ID Numbers: 7687
• First Posted: Apr 15, 2014
• Last Update Posted: Apr 15, 2014
• Last Verified: Apr 1, 2014

• Additional relevant MeSH terms: Urinary Tract Infections; Bacteriuria; Anti-Infective Agents; Anti-Bacterial Agents

Study Results

No Results Posted as of Apr 15, 2014