Prophylaxis of Post-Renal Transplant Urinary Tract Infection With Fosfomycin Trometamol. A Controlled, Randomized Clinical Trial. (Intermediate Analysis)

J. Arreola-Guerra,¹ L. Morales-Buenrostro,³ M. Arvizu-Hernandez,³ E. Mancilla-Urrea,² P. Maria,² M. Vilatoba-Chapa,¹ J. Alberu,¹ J. Sifuentes-Osornio.¹

¹Transplantation, National Institute of Medical Sciences an Nutrition Salvador Zubirán, Mexico City, Mexico
²Transplantation, National Institute of Cardiology Ignacio Chavez, Mexico City, Mexico
³Nephrology and Mineral Metabolism, National Institute of Medical Sciences an Nutrition Salvador Zubirán, Mexico City, Mexico.

Meeting: 2015 American Transplant Congress

Abstract number: B18

Keywords: Infection, Kidney transplantation, Prophylaxis

Session Information

Session Name: Poster Session B: Bacterial/Fungal/Other Infections

Session Type: Poster Session

Date: Sunday, May 3, 2015

Session Time: 5:30pm-6:30pm

Presentation Time: 5:30pm-6:30pm

Location: Exhibit Hall E

Background: Urinary tract infection (UTI) is the most frequent infection during post-transplant (pTR) follow-up. Aim: To compare the incidence of UTI during the first 6 months pTR with prophylaxis with FT vs. TMP-SMX. Methodology: This is a controlled, randomized, double-blind clinical trial comparing prophylaxis with FT at a dose of 3gr q/10 d + TMP-SMX 875/125 (3 x week) vs. TMP-SMX 875/125 q/24hrs. Transplanted patients over the age of 18 were included. The primary outcome was the time period to the first UTI episode. UTI was defined as a mid-stream urine culture with >100 thousand colony-forming units (CFU) and wo/symptoms or over 1000 CFU w/symptoms. Results: Between 05/2013 and 06/2014, 63 patients were included. Average age was 35.2 yrs (min-max 18 to 72) and 63.4% were male. They were randomized with 32 patients in the FT group and 31 patients in the TMP-SMX group. Median follow-up was 4.9 months (IIC 2.5 to 6.0). There were no significant differences between groups in terms of their general characteristics and UTI risk factors. During follow-up, 23 patients developed at least one UTI episode, with an overall incidence of 36.51%. When comparing the primary outcome, there was no difference between groups (HR1.05 95%CI 0.46 to 2.38 p=0.906). No difference was detected in subgroup analysis. Adverse effects were also not different between groups.

Main and secondary outcomes
Outcome	FT (n=32)	TMP-SMX (n=31)	p value
UTI+ AB	20 (62.5%)	11(35.48%)	0.032
UTI	12(37.5%)	11 (35.48%)	0.86
UTI rec + Pyelo	4(12.9%)	8(25.8%)	0.335
UTI symptomatic	6 (18.75%)	5 (16.13%)	1.00
Hosp. due to UTI	2 (6.2%)	2 (6.2%)	1.0

Hosp: Hospitalization, Pyelo: Pyelonephritis, rec: recurrent Conclusions: FT + TMP-SMX 3 times a week is equivalent to TMP-SMX conventional therapy. Due to the growing use of FT in the treatment of UTI and the potential increase in microbial resistance if FT is used prophylactically, we believe it should only be used with prophylactic purposes in patients with TMP-SMX allergy or intolerance. Clinicaltrials.gov identifier: NCT01820897

To cite this abstract in AMA style:

Arreola-Guerra J, Morales-Buenrostro L, Arvizu-Hernandez M, Mancilla-Urrea E, Maria P, Vilatoba-Chapa M, Alberu J, Sifuentes-Osornio J. Prophylaxis of Post-Renal Transplant Urinary Tract Infection With Fosfomycin Trometamol. A Controlled, Randomized Clinical Trial. (Intermediate Analysis) [abstract]. Am J Transplant. 2015; 15 (suppl 3). https://atcmeetingabstracts.com/abstract/prophylaxis-of-post-renal-transplant-urinary-tract-infection-with-fosfomycin-trometamol-a-controlled-randomized-clinical-trial-intermediate-analysis/. Accessed May 16, 2025.

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