Prospective Comparative Study About Treatment of Asymptomatic Bacteriuria in Kidney Transplant Recipients.

López-Medrano, Francisco, M.D.

Status: Completed

Conditions: Asymptomatic Bacteriuria

Treatments: Other: Antibiotic adjusted to antibiogram

Study type: Interventional

Identifiers

NCT02373085

ABTxR-H12O

Details and patient eligibility

About

Antimicrobial treatment of asymptomatic bacteriuria (AB) in kidney transplant recipients (KTR) is controversial. The investigators performed a comparative, parallel-group, randomized, open-label study to assess, in a real clinical setting, the feasibility of and benefit derived from systematic search and antimicrobial treatment of all episodes of AB.

Full description

All patients undergoing KT between January 2011 and December 2013 in a tertiary-care center with an active transplantation program were systematically searched for AB within the first 2 years after transplantation on a regular basis. During the first 2 months after transplantation all episodes of AB were treated. Thereafter, patients were assigned, according to a computer-generated randomization sequence, to group A (systematic antimicrobial treatment of all episodes of AB) or group B (no treatment). Treatment was chosen according to the results of the urine culture.

Enrollment: 112 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients developing asymptomatic bacteriuria beyond 2 months after transplantation.

Exclusion criteria

• <18 years old
• Pregnant women
• Kidney-pancreas transplantation
• Double J stent catheterization at the momento of randomization
• Permanent vesical catheter

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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112 participants in 2 patient groups

A: Antibiotic adjusted to antibiogram

Experimental group

Description:

A course of 3-14 days of antimicrobial treatment, according to the antibiogram results, will be prescribed for every episode of asymptomatic bacteriuria beyond 2 months after transplantation and during the first 2 years after transplantation

Treatment:

Other: Antibiotic adjusted to antibiogram

B: no treatment

No Intervention group

Description:

No treatment of any episode of asymptomatic bacteriuria beyond 2 months after transplantation in kidney transplant recipients.