Asymptomatic Bacteriuria in Early Kidney Transplantation Follow up

NCT04333602 | Completed DMC

• 1 other identifier: 2019-R-03
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (3)

• Incidence of symptomatic urinary tract infection

  urinary symptoms associated with positive urine culture

  Two months

• Time to the first symptomatic urinary tract infection

  urinary symptoms associated with positive urine culture

  Two moths

• Incidence of pyelonephritis or hospitalization related to urinary tract infection

  Two months

Secondary Outcomes (1)

• Bacterial virulence genes related to urinary tract infection

  Two moths

Study Arms (2)

Screening and Treatment of Asymptomatic Bacteriruria

EXPERIMENTAL

All patients assigned to this arm will be screen with urine culture: post- bladder catheter removal, three weeks post-transplant and before double-J ureteral stent removal. If we detect asymptomatic bacteriuria specific treatment will be instituted.

Diagnostic Test: Urinary culture and treatment if asymptomatic bacteriuria is detected

Screening and NO treatment of Asymptomatic Bacteriuria

NO INTERVENTION

All patients assigned to this arm will be screen with urine culture: post- bladder catheter removal, three weeks post-transplant and before double-J ureteral stent removal. No treatment will be instituted.

Interventions

Urinary culture and treatment if asymptomatic bacteriuria is detected DIAGNOSTIC_TEST

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.

Also known as: Clinical decision based in the presence of asymptomatic bacteriuria

Screening and Treatment of Asymptomatic Bacteriruria

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Kidney transplant candidates scheduled for the procedure

You may not qualify if:

• Patients with urological complications that did not have a bladder catheter and/or double J ureteral stent removed during the study period.

Sponsors & Collaborators

• Centenario Hospital Miguel Hidalgo: lead

Study Sites (1)

Jose Manuel Arreola

Aguascalientes, 20230, Mexico

Location

Related Publications (17)

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  PMID: 23917724 BACKGROUND

• Britt NS, Hagopian JC, Brennan DC, Pottebaum AA, Santos CAQ, Gharabagi A, Horwedel TA. Effects of recurrent urinary tract infections on graft and patient outcomes after kidney transplantation. Nephrol Dial Transplant. 2017 Oct 1;32(10):1758-1766. doi: 10.1093/ndt/gfx237.

  PMID: 28967964 BACKGROUND

• Sorto R, Irizar SS, Delgadillo G, Alberu J, Correa-Rotter R, Morales-Buenrostro LE. Risk factors for urinary tract infections during the first year after kidney transplantation. Transplant Proc. 2010 Jan-Feb;42(1):280-1. doi: 10.1016/j.transproceed.2009.11.029.

  PMID: 20172330 BACKGROUND

• de Souza RM, Olsburgh J. Urinary tract infection in the renal transplant patient. Nat Clin Pract Nephrol. 2008 May;4(5):252-64. doi: 10.1038/ncpneph0781. Epub 2008 Mar 11.

  PMID: 18334970 BACKGROUND

• Kidney Disease: Improving Global Outcomes (KDIGO) Transplant Work Group. KDIGO clinical practice guideline for the care of kidney transplant recipients. Am J Transplant. 2009 Nov;9 Suppl 3:S1-155. doi: 10.1111/j.1600-6143.2009.02834.x.

  PMID: 19845597 BACKGROUND

• Kawecki D, Kwiatkowski A, Sawicka-Grzelak A, Durlik M, Paczek L, Chmura A, Mlynarczyk G, Rowinski W, Luczak M. Urinary tract infections in the early posttransplant period after kidney transplantation: etiologic agents and their susceptibility. Transplant Proc. 2011 Oct;43(8):2991-3. doi: 10.1016/j.transproceed.2011.09.002.

  PMID: 21996207 BACKGROUND

• Origuen J, Fernandez-Ruiz M, Lopez-Medrano F, Ruiz-Merlo T, Gonzalez E, Morales JM, Fiorante S, San-Juan R, Villa J, Orellana MA, Andres A, Aguado JM. Progressive increase of resistance in Enterobacteriaceae urinary isolates from kidney transplant recipients over the past decade: narrowing of the therapeutic options. Transpl Infect Dis. 2016 Aug;18(4):575-84. doi: 10.1111/tid.12547. Epub 2016 Jul 4.

  PMID: 27373698 BACKGROUND

• Falagas ME, Kastoris AC, Kapaskelis AM, Karageorgopoulos DE. Fosfomycin for the treatment of multidrug-resistant, including extended-spectrum beta-lactamase producing, Enterobacteriaceae infections: a systematic review. Lancet Infect Dis. 2010 Jan;10(1):43-50. doi: 10.1016/S1473-3099(09)70325-1.

  PMID: 20129148 BACKGROUND

• Origuen J, Lopez-Medrano F, Fernandez-Ruiz M, Polanco N, Gutierrez E, Gonzalez E, Merida E, Ruiz-Merlo T, Morales-Cartagena A, Perez-Jacoiste Asin MA, Garcia-Reyne A, San Juan R, Orellana MA, Andres A, Aguado JM. Should Asymptomatic Bacteriuria Be Systematically Treated in Kidney Transplant Recipients? Results From a Randomized Controlled Trial. Am J Transplant. 2016 Oct;16(10):2943-2953. doi: 10.1111/ajt.13829. Epub 2016 May 23.

  PMID: 27088545 BACKGROUND

• Nicolle LE, Bradley S, Colgan R, Rice JC, Schaeffer A, Hooton TM; Infectious Diseases Society of America; American Society of Nephrology; American Geriatric Society. Infectious Diseases Society of America guidelines for the diagnosis and treatment of asymptomatic bacteriuria in adults. Clin Infect Dis. 2005 Mar 1;40(5):643-54. doi: 10.1086/427507. Epub 2005 Feb 4. No abstract available.

  PMID: 15714408 BACKGROUND

• Magiorakos AP, Srinivasan A, Carey RB, Carmeli Y, Falagas ME, Giske CG, Harbarth S, Hindler JF, Kahlmeter G, Olsson-Liljequist B, Paterson DL, Rice LB, Stelling J, Struelens MJ, Vatopoulos A, Weber JT, Monnet DL. Multidrug-resistant, extensively drug-resistant and pandrug-resistant bacteria: an international expert proposal for interim standard definitions for acquired resistance. Clin Microbiol Infect. 2012 Mar;18(3):268-81. doi: 10.1111/j.1469-0691.2011.03570.x. Epub 2011 Jul 27.

  PMID: 21793988 BACKGROUND

• Bauer MP, Kuijper EJ, van Dissel JT; European Society of Clinical Microbiology and Infectious Diseases. European Society of Clinical Microbiology and Infectious Diseases (ESCMID): treatment guidance document for Clostridium difficile infection (CDI). Clin Microbiol Infect. 2009 Dec;15(12):1067-79. doi: 10.1111/j.1469-0691.2009.03099.x.

  PMID: 19929973 BACKGROUND

• Arreola-Guerra JM, Rosado-Canto R, Alberu J, Maravilla E, Torres-Gonzalez P, Criollo E, Perez M, Mancilla E, Arvizu M, Morales-Buenrostro LE, Vilatoba-Chapa M, Sifuentes-Osornio J. Fosfomycin trometamol in the prophylaxis of post-kidney transplant urinary tract infection: A controlled, randomized clinical trial. Transpl Infect Dis. 2018 Oct;20(5):e12980. doi: 10.1111/tid.12980. Epub 2018 Sep 10.

  PMID: 30133928 BACKGROUND

• Alangaden GJ, Thyagarajan R, Gruber SA, Morawski K, Garnick J, El-Amm JM, West MS, Sillix DH, Chandrasekar PH, Haririan A. Infectious complications after kidney transplantation: current epidemiology and associated risk factors. Clin Transplant. 2006 Jul-Aug;20(4):401-9. doi: 10.1111/j.1399-0012.2006.00519.x.

  PMID: 16842513 RESULT

• Parasuraman R, Julian K; AST Infectious Diseases Community of Practice. Urinary tract infections in solid organ transplantation. Am J Transplant. 2013 Mar;13 Suppl 4:327-36. doi: 10.1111/ajt.12124. No abstract available.

  PMID: 23465025 RESULT

• Fiorante S, Lopez-Medrano F, Lizasoain M, Lalueza A, Juan RS, Andres A, Otero JR, Morales JM, Aguado JM. Systematic screening and treatment of asymptomatic bacteriuria in renal transplant recipients. Kidney Int. 2010 Oct;78(8):774-81. doi: 10.1038/ki.2010.286. Epub 2010 Aug 18.

  PMID: 20720526 RESULT

• Golebiewska JE, Debska-Slizien A, Rutkowski B. Treated asymptomatic bacteriuria during first year after renal transplantation. Transpl Infect Dis. 2014 Aug;16(4):605-15. doi: 10.1111/tid.12255. Epub 2014 Jul 1.

  PMID: 24980847 RESULT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Both the patient, the primary doctor and the laboratory worker do not know the result of the culture. Only the doctors in charge of this process know the result and contact the patient directly if they are in the treatment group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Research department and Nephrologist

Model Details: Group 1: Asymptomatic Bacteriuria screening and treatment and Group 2: Asymptomatic Bacteriuria screening and No treatment for AB.

Study Record Dates

• First Submitted: April 1, 2020
• First Posted: April 3, 2020
• Study Start: January 1, 2020
• Primary Completion: February 16, 2022
• Study Completion: February 16, 2022
• Last Updated: February 17, 2022

Record last verified: 2022-02

Locations

ME (1)