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Asymptomatic Bacteriuria in Early Kidney Transplantation Follow up

NCT04333602 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2022-02-17

No results posted yet for this study

Summary

Urinary tract infection (UTI) continues to be the leading cause of infection and hospitalization in post-kidney transplant (RT) surveillance. Facts such as immunosuppression, anatomical alterations and catheters are part of the factors that contribute to a high prevalence of this condition. The incidence during the first trimester is highly variable and ranges between 15 and 50 %. This variability often depends on the definition of UTI, which sometimes overlaps with asymptomatic bacteriuria (AB). Currently the indication for treatment of AB is clear in pregnant patients and urological procedures. In post-RT surveillance, the treatment of AB is controversial. The use of Trimetropim Sulfamethoxazole during the first 6 months post RT is currently a recommendation, however new evidence has found the absence of benefit in the treatment of AB. Given the high prevalence of post RT AB and the increase in bacterial resistance, determining the usefulness of searching for and treating post RT AB is a priority in this population. Methodology: Randomized Controlled trial of kidney transplant candidates which will be randomized in the following groups: Group 1 (intervention) where the urine cultures will be analyzed openly, and in the case of asymptomatic bacteriuria, treatment based on the germ and antibiogram will be prescribed. Group 2 will undergo urine cultures at the same post-transplant times, the results will not be known by the clinical team and the participants will not receive treatment in the presence of present AB. Both groups, in the presence of UTI symptoms, will undergo urine culture and receive empirical treatment, which will be adjusted based on an antibiogram. The primary objective is to assess the prevalence of UTI, pyelonephritis, UTI-related hospitalizations, and antimicrobial resistance. As a secondary objective, the germs and associated virulence genes will be analyzed. Surveillance will be carried out for two months after transplantation and the predefined times for the evaluation of the BA will be: after the removal of the urinary catheter, week 3 and after the removal of the ureteral stent (month 2).

Conditions

  • Asymptomatic Bacteriuria
  • Kidney Transplant Infection

Interventions

DIAGNOSTIC_TEST

Urinary culture and treatment if asymptomatic bacteriuria is detected

Urinary culture: post- bladder catheter removal, three weeks post-transplant and before double-J ureteral stent removal. Based in the assigned group If we detect asymptomatic bacteriuria specific treatment will be instituted or No treatment.

Sponsors & Collaborators

  • Centenario Hospital Miguel Hidalgo

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-01
Primary Completion
2022-02-16
Completion
2022-02-16

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04333602 on ClinicalTrials.gov