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

• Status: Completed
• Trial end date: 2017-11-06
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
• Collaborator: Laboratorios Senosiain, S.A. de C.V.
• Treatments: Fosfomycin; Sulfamethoxazole; Trimethoprim

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• Allergy to Fosfomycin disodium or Trimethoprim / Sulfamethoxazole