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

Asymptomatic Bacteriuria Clinical Trial

Official title:

Effect of Systematic Search and Antimicrobial Treatment of Asymptomatic Bacteriuria in Kidney Transplant Recipients in the Incidence of Acute Pyelonephritis: a Pragmatic Prospective Randomized Controlled Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02373085
• Other study ID #: ABTxR-H12O
• Status: Completed
• Phase: N/A
• First received: February 13, 2015
• Last updated: February 20, 2015
• Start date: January 2011
• Est. completion date: January 2015

Study information

• Verified date: February 2015
• Source: López-Medrano, Francisco, M.D.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: January 2015
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Asymptomatic Bacteriuria
• Bacteriuria

Intervention

Other:
• Antibiotic adjusted to antibiogram
A course of 3-14 days of antimicrobial treatment, according to the antibiogram results, will be prescribed for every episode of asymptomatic bacteriuria during the first 2 years after transplantation.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
López-Medrano, Francisco, M.D.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Pyelonephritis	The number of patients that develope pyelonephritis in the first 2 years after transplantation in each group, divided by the number of patients allocated in each group at randomization.	2 years after transplantation	No
Secondary	Incidence of lower tract urinary infection	The number of patients that develope lower tract urinary infection in the first 2 years after transplantation in each group, divided by the number of patients allocated in each group at randomization.	2 years after transplantation	No
Secondary	Incidence of Clostridium difficile infection	The number of patients that develope Clostridium difficile infection in the first 2 years after transplantation in each group, divided by the number of patients allocated in each group at randomization.	2 years after transplantation	Yes
Secondary	Incidence of multidrug resistant bacteria colonization/infection	The number of patients that develope multidrug resistant bacteria colonization/infection in the first 2 years after transplantation in each group, divided by the number of patients allocated in each group at randomization.	2 years after transplantation	Yes
Secondary	Long-term graft function	Long-term graft function measured by average serum creatinine at several points until the end of follow-up.	At 1 year and 2 years after transplantation	No