Options of modern anti-relapse therapy for urinary tract infections in children: CRUTIL trial

Background. Recurrent urinary tract infection (UTI) is a serious problem in pediatric nephrology, affecting the qua­lity of life and increasing the burden on the health system. Consi­deration of individual factors and the development of approaches to anti-relapse therapy, especially in children with...

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Main Authors: D.D. Ivanov, T.P. Ivanova, O.G. Fedorenko, S.V. Kushnirenko, M.D. Ivanova
Format: Article
Language:English
Published: Zaslavsky O.Yu. 2019-03-01
Series:Počki
Subjects:
Online Access:http://kidneys.zaslavsky.com.ua/article/view/166663
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author D.D. Ivanov
T.P. Ivanova
O.G. Fedorenko
S.V. Kushnirenko
M.D. Ivanova
author_facet D.D. Ivanov
T.P. Ivanova
O.G. Fedorenko
S.V. Kushnirenko
M.D. Ivanova
author_sort D.D. Ivanov
collection DOAJ
description Background. Recurrent urinary tract infection (UTI) is a serious problem in pediatric nephrology, affecting the qua­lity of life and increasing the burden on the health system. Consi­deration of individual factors and the development of approaches to anti-relapse therapy, especially in children without apparent objective reasons for the relapse of infection, is an urgent task. Materials and methods. A prospective, multicentre, randomized, parallel-group, open-label CRUTIL (Children’s Recurrent Urinary Tract Infections on bacterial Lysate) study was conducted, it included 83 children aged 3 to 15 years (8.0 ± 2.2 years) with recurrent UTI. The children were randomized into 3 groups: the first one — 22 patients who received supplementary therapy with Urivac lysate, the second one — 28 children who received supplementary therapy with Uro-Vaxom lysate, and the third group (controls) — 33 patients who received standard therapy. Duration of immunoactive therapy was 6 months, patients of these groups also received anti-relapse treatment with a single dose of urinary antiseptic at bedtime for 18 months; follow-up was 24 months. Results. In the first group of children who received Urivac, a 6-valent vaccine from bacterial lysates, a non-recurrent course to the end of the study was observed in 19 patients (87 %). In the group receiving Uro-Vaxom bacterial monolysates, 20 children (72 %) had non-recurrent course (odds ratio (OR) = 2.5; P > 0.05; the minimum expected effect was 4.84). Among those who did not receive urinary antiseptic at bedtime and bacterial lysates, the non-recurrent course was reported in 13 children (40 %) (P ≤ 0.05, OR = 0.26 with a 6-valent vaccine group). A 15% improvement in the effectiveness was obtained due to elimination of Pseudomonas aeruginosa and Enterococcus faecalis when using a 6-valent bacterial lysate. Subsequently, from 24 to 30 months of follow-up, 3 more children in the Uro-Vaxom group had a relapse (P ≤ 0.05 with the Urivac group). Conclusions. Bacterial lysates significantly increase the effectiveness of therapy for recurrent urinary tract infections in children. The best results in the formation of a non-recurrent course of relapsing UTI were obtained when using a prophylactic dose of urinary antiseptic once at bedtime and a 6-valent Urivac vaccine.
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spelling doaj.art-66dc39eb0a3449ceb36aa83ac363c9582022-12-21T16:43:14ZengZaslavsky O.Yu.Počki2307-12572307-12652019-03-0182808710.22141/2307-1257.8.2.2019.166663166663Options of modern anti-relapse therapy for urinary tract infections in children: CRUTIL trialD.D. Ivanov0T.P. Ivanova1O.G. Fedorenko2S.V. Kushnirenko3M.D. Ivanova4Shupyk National Medical Academy of Postgraduate Education, Kyiv, UkraineNCSH “OHMATDYT”, Kyiv, UkraineMedical Practice of prof. D. Ivanov, Kyiv, UkraineShupyk National Medical Academy of Postgraduate Education, Kyiv, UkraineUniversità degli Studi di Milano-Bicocca, Milano, ItalyBackground. Recurrent urinary tract infection (UTI) is a serious problem in pediatric nephrology, affecting the qua­lity of life and increasing the burden on the health system. Consi­deration of individual factors and the development of approaches to anti-relapse therapy, especially in children without apparent objective reasons for the relapse of infection, is an urgent task. Materials and methods. A prospective, multicentre, randomized, parallel-group, open-label CRUTIL (Children’s Recurrent Urinary Tract Infections on bacterial Lysate) study was conducted, it included 83 children aged 3 to 15 years (8.0 ± 2.2 years) with recurrent UTI. The children were randomized into 3 groups: the first one — 22 patients who received supplementary therapy with Urivac lysate, the second one — 28 children who received supplementary therapy with Uro-Vaxom lysate, and the third group (controls) — 33 patients who received standard therapy. Duration of immunoactive therapy was 6 months, patients of these groups also received anti-relapse treatment with a single dose of urinary antiseptic at bedtime for 18 months; follow-up was 24 months. Results. In the first group of children who received Urivac, a 6-valent vaccine from bacterial lysates, a non-recurrent course to the end of the study was observed in 19 patients (87 %). In the group receiving Uro-Vaxom bacterial monolysates, 20 children (72 %) had non-recurrent course (odds ratio (OR) = 2.5; P > 0.05; the minimum expected effect was 4.84). Among those who did not receive urinary antiseptic at bedtime and bacterial lysates, the non-recurrent course was reported in 13 children (40 %) (P ≤ 0.05, OR = 0.26 with a 6-valent vaccine group). A 15% improvement in the effectiveness was obtained due to elimination of Pseudomonas aeruginosa and Enterococcus faecalis when using a 6-valent bacterial lysate. Subsequently, from 24 to 30 months of follow-up, 3 more children in the Uro-Vaxom group had a relapse (P ≤ 0.05 with the Urivac group). Conclusions. Bacterial lysates significantly increase the effectiveness of therapy for recurrent urinary tract infections in children. The best results in the formation of a non-recurrent course of relapsing UTI were obtained when using a prophylactic dose of urinary antiseptic once at bedtime and a 6-valent Urivac vaccine.http://kidneys.zaslavsky.com.ua/article/view/166663recurrent urinary tract infections in childrenindustrial bacterial lysatesUrivacUro-Vaxomfollow-up in urinary tract infections
spellingShingle D.D. Ivanov
T.P. Ivanova
O.G. Fedorenko
S.V. Kushnirenko
M.D. Ivanova
Options of modern anti-relapse therapy for urinary tract infections in children: CRUTIL trial
Počki
recurrent urinary tract infections in children
industrial bacterial lysates
Urivac
Uro-Vaxom
follow-up in urinary tract infections
title Options of modern anti-relapse therapy for urinary tract infections in children: CRUTIL trial
title_full Options of modern anti-relapse therapy for urinary tract infections in children: CRUTIL trial
title_fullStr Options of modern anti-relapse therapy for urinary tract infections in children: CRUTIL trial
title_full_unstemmed Options of modern anti-relapse therapy for urinary tract infections in children: CRUTIL trial
title_short Options of modern anti-relapse therapy for urinary tract infections in children: CRUTIL trial
title_sort options of modern anti relapse therapy for urinary tract infections in children crutil trial
topic recurrent urinary tract infections in children
industrial bacterial lysates
Urivac
Uro-Vaxom
follow-up in urinary tract infections
url http://kidneys.zaslavsky.com.ua/article/view/166663
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