Perioperative Fosfomycin in the Prophylaxis of Urinary Tract Infection in Kidney Transplant Recipients

NCT03235947 | Completed Phase 4

• 1 other identifier: 1649
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

A clinical controlled, randomized and double blind trial that included adult patients (≥18 years) receiving kidney transplantation (KT) at the INCMNSZ. The intervention group will receive disodium fosfomycin 4 g intravenously in three moments: preoperative of transplant surgery, prior to removal of the urinary catheter and finally prior to removal of ureteral catheter. The control group will receive placebo in the same moments. Both groups will receive prophylaxis standard for urinary tract infection (UTI), with trimethoprim/sulfamethoxazole 160/800 mg per day. This prophylaxis will be administered once the estimated glomerular filtration rate is greater than 30 mL/min/1.73m2. The primary objective is to compare the average number of episodes of UTI´s and asymptomatic bacteriuria in both groups after 7 weeks of follow-up. The secondary objectives are to know the incidence of asymptomatic bacteriuria, the incidence of hospitalizations for IVU, the days of hospital stay, the pattern of bacterial resistance, the safety of disodium fosfomycin, and assessment of the function of the graft and rejection rate.

Conditions

Urinary Tract Infection; Asymptomatic Bacteriuria

Keywords

Renal transplant; Antimicrobian prophylaxis; Fosfomycin; Urinary tract infection; Asymptomatic bacteriuria

Outcome Measures

Primary Outcomes (1)

• To compare the efficacy of Fosfomycin-disodium/Trimethoprim-sulfamethoxazole with Placebo/Trimetoprim-sulfamexazol in the prophylaxis of urinary tract infection or significant asymptomatic bacteriuria among kidney transplantation recipients.

  The primary outcome in this clinical trial is the comparison of the mean number of episodes of urinary tract infection or significant asymptomatic bacteriuria, per patient in both arms of treatment among kidney transplantation recipients during the first seven weeks after surgery.

  7-weeks after transplantation

Secondary Outcomes (1)

• The elapsed time period until the first urinary tract infection or asymptomatic bacteriuria developed

  7-weeks after transplantation

Other Outcomes (7)

• Incidence of urinary tract infection

  7-weeks after transplantation

• Incidence of asymptomatic bacteriuria

  7-weeks after transplantation

• Incidence of bacteremia

  7-weeks after transplantation

Study Arms (2)

Fosfomycin disodium

EXPERIMENTAL

* Fosfomycin disodium 4 g intravenously: 3 hours before kidney transplant surgery, 3 hours before urinary catheter removal and 3 hours prior to ureteral catheter removal. * Trimethoprim / Sulfamethoxazole (160/800 mg) 1 tablet orally every 24 hours.

Drug: Fosfomycin disodium; Drug: Trimethoprim / Sulfamethoxazole

Trimethoprim / Sulfamethoxazole

ACTIVE COMPARATOR

* Trimethoprim / Sulfamethoxazole (160/800 mg) 1 tablet orally every 24 hours. * Intravenous placebo solution at the same time of application of fosfomycin disodium in the experimental arm.

Drug: Trimethoprim / Sulfamethoxazole; Drug: Intravenous placebo

Interventions

Fosfomycin disodium DRUG

Fosfomycin disodium 4 g intravenously dissolved in 100 mL of normal saline 0.9% three times in the perioperative period of renal transplant surgery.

Fosfomycin disodium

Trimethoprim / Sulfamethoxazole DRUG

Trimethoprim / Sulfamethoxazole (160/800 mg) orally every 24 hours during the study follow-up (7 weeks)

Fosfomycin disodium; Trimethoprim / Sulfamethoxazole

Intravenous placebo DRUG

Normal saline 0.9% 100 mL intravenous administered three times in the perioperative period of the renal transplant, at the same times corresponding to disodium fosfomycin

Trimethoprim / Sulfamethoxazole

Eligibility Criteria

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

You may qualify if:

• Patients transplanted in the Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran.

You may not qualify if:

• Allergy to Fosfomycin disodium or Trimethoprim / Sulfamethoxazole

Sponsors & Collaborators

• Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran: lead
• Laboratorios Senosiain, S.A. de C.V.: collaborator

Study Sites (1)

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Mexico City, 14080, Mexico

Location

Related Publications (9)

• Linares L, Cervera C, Cofan F, Ricart MJ, Esforzado N, Torregrosa V, Oppenheimer F, Campistol JM, Marco F, Moreno A. Epidemiology and outcomes of multiple antibiotic-resistant bacterial infection in renal transplantation. Transplant Proc. 2007 Sep;39(7):2222-4. doi: 10.1016/j.transproceed.2007.06.061.

  PMID: 17889144 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

• Senger SS, Arslan H, Azap OK, Timurkaynak F, Cagir U, Haberal M. Urinary tract infections in renal transplant recipients. Transplant Proc. 2007 May;39(4):1016-7. doi: 10.1016/j.transproceed.2007.02.060.

  PMID: 17524879 BACKGROUND

• Figueroa-Sánchez G, Arreola-Guerra JM, Morales-Buenrostro LE. Time of presentation and antimicrobial resistance pattern of urinary tract infection in the early period after kidney transplantation. Rev Mex Traspl 2016; 5: 20-26.

  BACKGROUND

• Falagas ME, Kastoris AC, Karageorgopoulos DE, Rafailidis PI. Fosfomycin for the treatment of infections caused by multidrug-resistant non-fermenting Gram-negative bacilli: a systematic review of microbiological, animal and clinical studies. Int J Antimicrob Agents. 2009 Aug;34(2):111-20. doi: 10.1016/j.ijantimicag.2009.03.009. Epub 2009 Apr 28.

  PMID: 19403273 BACKGROUND

• Wagenlehner FM, Thomas PM, Naber KG. Fosfomycin trometamol (3,000 mg) in perioperative antibiotic prophylaxis of healthcare-associated infections after endourological interventions: a narrative review. Urol Int. 2014;92(2):125-30. doi: 10.1159/000355103. Epub 2013 Sep 13.

  PMID: 24051657 BACKGROUND

• Clinical and Laboratory Standards Institute. Performance standards for antimicrobial susceptibility testing; twenty-fourth informational supplement. Document M100-S24. Wayne, PA: CLSI; 2014.

  BACKGROUND

• The European Committee on Antimicrobial Susceptibility Testing. Breakpoint tables for interpretation of MICs and zone diameters. Version 6.0, 2016. http://www.eucast.org

  BACKGROUND

• Rosado-Canto R, Parra-Avila I, Tejeda-Maldonado J, Kauffman-Ortega C, Rodriguez-Covarrubias FT, Trujeque-Matos M, Cruz-Martinez R, Maravilla-Franco E, Criollo-Mora E, Arreola-Guerra JM, Morales-Buenrostro LE, Sifuentes-Osornio J. Perioperative fosfomycin disodium prophylaxis against urinary tract infection in renal transplant recipients: a randomized clinical trial. Nephrol Dial Transplant. 2020 Nov 1;35(11):1996-2003. doi: 10.1093/ndt/gfz261.

  PMID: 31883327 DERIVED

MeSH Terms

Conditions

Urinary Tract Infections

Interventions

Trimethoprim, Sulfamethoxazole Drug Combination

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Sulfamethoxazole; Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Sulfanilamides; Aniline Compounds; Amines; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Trimethoprim; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Study Officials

• José Sifuentes-Osornio, MD

  Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a randomized, parallel-group, controlled clinical trial conducted in a single center that will include renal transplant recipients over the age of 18 to assess the efficacy and safety of disodium fosfomycin in the perioperative period of renal transplantation. The intervention group will receive intravenous fosfomycin 4 g disodium three hours prior to: renal transplant surgery, removal of the urinary catheter and withdrawal of the ureteral catheter. The control group will receive placebo at the same time. Both groups will receive standard prophylaxis consisting of trimethoprim / sulfamethoxazole (160/800 mg) orally every 24 hours when the GFR is greater than 30 mL / min / 1.73m2.

Study Record Dates

• First Submitted: June 6, 2017
• First Posted: August 1, 2017
• Study Start: September 7, 2016
• Primary Completion: November 6, 2017
• Study Completion: November 6, 2017
• Last Updated: November 13, 2017

Record last verified: 2017-11

Locations

ME (1)