Urinary Tract Infection Clinical Trial
— PERIFOSOfficial title:
Perioperative Disodium Fosfomycin in the Prophylaxis of Urinary Tract Infection in Kidney Transplant Recipients. Controlled Clinical Trial (PERIFOS Trial)
Verified date | November 2017 |
Source | Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 82 |
Est. completion date | November 6, 2017 |
Est. primary completion date | November 6, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients transplanted in the Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran. Exclusion Criteria: - Allergy to Fosfomycin disodium or Trimethoprim / Sulfamethoxazole |
Country | Name | City | State |
---|---|---|---|
Mexico | Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran | Mexico City |
Lead Sponsor | Collaborator |
---|---|
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran | Laboratorios Senosiain, S.A. de C.V. |
Mexico,
Clinical and Laboratory Standards Institute. Performance standards for antimicrobial susceptibility testing; twenty-fourth informational supplement. Document M100-S24. Wayne, PA: CLSI; 2014.
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. Review. — View Citation
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.
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. — View Citation
Linares L, Cervera C, Cofán 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. — View Citation
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. — View Citation
The European Committee on Antimicrobial Susceptibility Testing. Breakpoint tables for interpretation of MICs and zone diameters. Version 6.0, 2016. http://www.eucast.org
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. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Incidence of urinary tract infection | 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. | 7-weeks after transplantation | |
Other | Incidence of asymptomatic bacteriuria | 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. | 7-weeks after transplantation | |
Other | Incidence of bacteremia | 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. | 7-weeks after transplantation | |
Other | Incidence of hospitalization for urinary tract infection | 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. | 7-weeks after transplantation | |
Other | Incidence of Clostridium difficile infection | 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. | 7-weeks after transplantation | |
Other | Incidence of multidrug resistant bacteria colonization | 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-weeks after transplantation | |
Other | Incidence of acute rejection | 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. | 3-months after transplantation | |
Primary | 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 | The elapsed time period until the first urinary tract infection or asymptomatic bacteriuria developed | Refers to the elapsed time period until the first urinary tract infection or asymptomatic bacteriuria developed during the first 7 weeks post-KT | 7-weeks after transplantation |
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