Kidney Transplant Infection Clinical Trial
Official title:
Screening and Treatment of Asymptomatic Bacteriuria in the First Two Months After Kidney Transplant. Randomized Control Trial
Verified date | February 2022 |
Source | Centenario Hospital Miguel Hidalgo |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 80 |
Est. completion date | February 16, 2022 |
Est. primary completion date | February 16, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - Kidney transplant candidates scheduled for the procedure Exclusion Criteria: - Patients with urological complications that did not have a bladder catheter and/or double J ureteral stent removed during the study period. |
Country | Name | City | State |
---|---|---|---|
Mexico | Jose Manuel Arreola | Aguascalientes |
Lead Sponsor | Collaborator |
---|---|
Centenario Hospital Miguel Hidalgo |
Mexico,
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* Note: There are 17 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of symptomatic urinary tract infection | urinary symptoms associated with positive urine culture | Two months | |
Primary | Time to the first symptomatic urinary tract infection | urinary symptoms associated with positive urine culture | Two moths | |
Primary | Incidence of pyelonephritis or hospitalization related to urinary tract infection | Two months | ||
Secondary | Bacterial virulence genes related to urinary tract infection | E. Coli and Klebsiella. sp virulence genes will be analysed | Two moths |
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