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

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ClinicalTrials.gov Identifier: NCT03235947
Recruitment Status : Completed
First Posted : August 1, 2017
Last Update Posted : November 13, 2017
Sponsor:
Collaborator:
Laboratorios Senosiain, S.A. de C.V.
Information provided by (Responsible Party):
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

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.


Condition or disease Intervention/treatment Phase
Urinary Tract Infection Asymptomatic Bacteriuria Drug: Fosfomycin disodium Drug: Trimethoprim / Sulfamethoxazole Drug: Intravenous placebo Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Perioperative Disodium Fosfomycin in the Prophylaxis of Urinary Tract Infection in Kidney Transplant Recipients. Controlled Clinical Trial (PERIFOS Trial)
Actual Study Start Date : September 7, 2016
Actual Primary Completion Date : November 6, 2017
Actual Study Completion Date : November 6, 2017


Arm Intervention/treatment
Experimental: Fosfomycin disodium
  • 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
Fosfomycin disodium 4 g intravenously dissolved in 100 mL of normal saline 0.9% three times in the perioperative period of renal transplant surgery.

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

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

Drug: Intravenous placebo
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




Primary Outcome Measures :
  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. [ Time Frame: 7-weeks after transplantation ]
    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.


Secondary Outcome Measures :
  1. The elapsed time period until the first urinary tract infection or asymptomatic bacteriuria developed [ Time Frame: 7-weeks after transplantation ]
    Refers to the elapsed time period until the first urinary tract infection or asymptomatic bacteriuria developed during the first 7 weeks post-KT


Other Outcome Measures:
  1. Incidence of urinary tract infection [ Time Frame: 7-weeks after transplantation ]
    The number of patients that develope tract urinary infection in the first seven weeks after transplantation in each group, divided by the number of patients allocated in each group at randomization.

  2. Incidence of asymptomatic bacteriuria [ Time Frame: 7-weeks after transplantation ]
    The number of patients that develope asymptomatic bacteriuria in the first seven weeks after transplantation in each group, divided by the number of patients allocated in each group at randomization.

  3. Incidence of bacteremia [ Time Frame: 7-weeks after transplantation ]
    The number of patients that develope bacteremia in the first seven weeks after transplantation in each group, divided by the number of patients allocated in each group at randomization.

  4. Incidence of hospitalization for urinary tract infection [ Time Frame: 7-weeks after transplantation ]
    The number of patients that develope hospitalization for urinary tract infection in the first seven weeks after transplantation in each group, divided by the number of patients allocated in each group at randomization.

  5. Incidence of Clostridium difficile infection [ Time Frame: 7-weeks after transplantation ]
    The number of patients that develope Clostridium difficile infection in the first seven weeks after transplantation in each group, divided by the number of patients allocated in each group at randomization.

  6. Incidence of multidrug resistant bacteria colonization [ Time Frame: 7-weeks after transplantation ]
    The number of patients that develope multidrug resistant bacteria colonization infection in the first seven weeks after transplantation in each group, divided by the number of patients allocated in each group at randomization.

  7. Incidence of acute rejection [ Time Frame: 3-months after transplantation ]
    The number of patients that develope acute rejection in the first seven weeks after transplantation in each group, divided by the number of patients allocated in each group at randomization.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03235947


Locations
Mexico
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Mexico City, Mexico, 14080
Sponsors and Collaborators
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Laboratorios Senosiain, S.A. de C.V.
Investigators
Principal Investigator: José Sifuentes-Osornio, MD Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Publications:
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.
Clinical and Laboratory Standards Institute. Performance standards for antimicrobial susceptibility testing; twenty-fourth informational supplement. Document M100-S24. Wayne, PA: CLSI; 2014.
The European Committee on Antimicrobial Susceptibility Testing. Breakpoint tables for interpretation of MICs and zone diameters. Version 6.0, 2016. http://www.eucast.org

Responsible Party: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
ClinicalTrials.gov Identifier: NCT03235947     History of Changes
Other Study ID Numbers: 1649
First Posted: August 1, 2017    Key Record Dates
Last Update Posted: November 13, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: The data would be available for future analysis for possible additional multicentered studies or metaanalysis.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran:
Renal transplant
Antimicrobian prophylaxis
Fosfomycin
Urinary tract infection
Asymptomatic bacteriuria

Additional relevant MeSH terms:
Infection
Communicable Diseases
Urinary Tract Infections
Bacteriuria
Urologic Diseases
Trimethoprim
Sulfamethoxazole
Fosfomycin
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP2C8 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Anti-Bacterial Agents