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Trial record 20 of 614 for:    Anti-Infective Agents AND susceptibility

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

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ClinicalTrials.gov Identifier: NCT02113774
Recruitment Status : Unknown
Verified April 2014 by Ruth Rahamimov, Rabin Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : April 15, 2014
Last Update Posted : April 15, 2014
Sponsor:
Information provided by (Responsible Party):
Ruth Rahamimov, Rabin Medical Center

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

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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Study Start Date : April 2014
Estimated Primary Completion Date : April 2019

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. development of symptomatic urinary tract infection [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. 25% reduction in estimated glomerular filtration rate (eGFR) [ Time Frame: 1 year ]

Other Outcome Measures:
  1. graft loss [ Time Frame: 1 year ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

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.

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Responsible Party: Ruth Rahamimov, head of transplant investigator service, Rabin Medical Center
ClinicalTrials.gov Identifier: NCT02113774     History of Changes
Other Study ID Numbers: 7687
First Posted: April 15, 2014    Key Record Dates
Last Update Posted: April 15, 2014
Last Verified: April 2014
Additional relevant MeSH terms:
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Urinary Tract Infections
Bacteriuria
Infection
Urologic Diseases
Anti-Bacterial Agents
Anti-Infective Agents