A Randomized, Double-Blind, Parallel-Group, Multicenter Clinical Study of Escherichia coli-Lyophilized Lysate for the Prophylaxis of Recurrent Uncomplicated Urinary Tract Infections

2015 ◽  
Vol 95 (2) ◽  
pp. 167-176 ◽  
Author(s):  
Florian M.E. Wagenlehner ◽  
Stefania Ballarini ◽  
Adrian Pilatz ◽  
Wolfgang Weidner ◽  
Lorenz Lehr ◽  
...  

Background: One strategy for managing recurrent uncomplicated urinary tract infections (UTIs) is prevention. This study tested OM-89S, a lyophilized lysate of 18 Escherichia coli strains manufactured using a modified lytic process. Methods: This was a randomized, double-blind trial in 451 female subjects with recurrent uncomplicated UTIs. Period 1 of the study tested 6 mg of OM-89S versus placebo (3 months), plus a 3-month observation. Period 2 of the study was a 3-month treatment period (each monthly cycle consisted of 6 mg of OM-89S daily for 10 days and placebo for 20 days, vs. 50 mg nitrofurantoin daily for 30 days), plus a 3-month observation. Results: There was no difference in the mean rate of UTI episodes between the OM-89S (0.66 ± 0.93) and placebo groups (0.63 ± 0.86; p = 0.95) in period 1. Similar findings were obtained for period 2. OM-89S was well-tolerated. Conclusions: Our results did not demonstrate a preventive effect of OM-89S compared to placebo. This may be due to the low number of UTIs that occurred during the study, the high number of protocol violations, and/or the modified manufacturing process used for OM-89S.

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S832-S833
Author(s):  
Fatma Hammami ◽  
Makram Koubaa ◽  
Amal Chakroun ◽  
Khaoula Rekik ◽  
Fatma Smaoui ◽  
...  

Abstract Background Bacterial urinary tract infections continue to be a major health problem, responsible for a significant morbidity and mortality. Its prognosis is more severe than non-bacterial forms. The aim of this work was to study the clinical and evolutionary features of bacterial urinary tract infections caused by Escherichia coli (E.coli). Methods We conducted a retrospective study including all patients hospitalized in infectious diseases department for urinary tract infection (UTI) caused by E.coli between 2010 and 2017. Results During the study period, we enrolled 613 cases of UTI caused by E.coli, among whom 75 cases (12.2%) were bacterial. There were 47 females (62.7%). The mean age was 59 ±17 years. Thirty-three patients were aged ≥ 65 years (44%). Diabetes was noted in 38 cases (50.7%) and renal lithiasis in 14 cases (18.7%). A history of UTI was reported in 13 cases (17.3%). The most common clinical presentation was acute pyelonephritis (59 cases; 78.7%) and followed by prostatitis (8 cases; 10.6%). Renal abscess was noted in 5 cases (6.7%) and prostatic abscess in 3 cases (4%). There were 36 cases of multidrug-resistant bacteria (48%). Community-acquired UTI were noted in 70 cases (93.3%). The mean duration of treatment was 18 ± 6 days. Surgery and radiological drainage were indicated in 4 (5.3%) and 2 cases (2.7%), respectively. The outcome was favourable in 58 cases (77.3%). Complications were noted in 10 cases (13.3%) represented mainly by acute renal failure in 4 cases (5.3%). Relapse was noted in 9 cases (12%) and reinfection in 6 cases (8%). Two patients died (2.7%). Conclusion Bacterial urinary tract infections were associated to complications such as renal and prostatic abscess, requiring surgery and long duration of treatment. Disclosures All Authors: No reported disclosures


2019 ◽  
Vol 19 (3) ◽  
pp. 322-326 ◽  
Author(s):  
Hassan Valadbeigi ◽  
Elham Esmaeeli ◽  
Sobhan Ghafourian ◽  
Abbas Maleki ◽  
Nourkhoda Sadeghifard

Introduction: The aim of the current study was to investigate the prevalence of virulence genes in uropathogenic Escherichia coli (UPEC) isolates in Ilam. Materials and Methods: For this purpose, a total of 80 UPEC isolates were collected for patients with UTIs during a 6 months period. The multiplex polymerase chain reaction (multiplex PCR) was used to detect the papEF, fimH, iucD, hlyA, fyuA, and ompT genes. Results: The prevalence of fimH, papEF, iucD, fyuA, hlyA, hlyA, and ompT genes were 87.5%, 47.5%, 60%, 67.5%, 27.5%, 47.5% and 71.2%, respectively. Among all of the isolates, 27 profiles were obtained. Conclusion: Our findings demonstrated that the most prevalence was found for fimH, and different distribution of virulence genes suggested different ability of pathogenicity.


2001 ◽  
Vol 45 (12) ◽  
pp. 3524-3530 ◽  
Author(s):  
Christoph K. Naber ◽  
Michaela Hammer ◽  
Martina Kinzig-Schippers ◽  
Christian Sauber ◽  
Fritz Sörgel ◽  
...  

ABSTRACT In a randomized crossover study, 16 volunteers (8 men, 8 women) received single oral doses of 320 mg of gemifloxacin and 400 mg of ofloxacin on two separate occasions in the fasting state to assess the urinary excretion and urinary bactericidal titers (UBTs) at intervals for up to 144 h. Ofloxacin showed higher concentrations in urine compared with those of gemifloxacin. The median (range) cumulative excretion of gemifloxacin was 29.7% (8.4 to 48.7%) of the parent drug administered, and median (range) cumulative excretion of ofloxacin was 84.3% (46.5 to 95.2%) of the parent drug administered. The UBTs, i.e., the highest twofold dilutions (with antibiotic-free urine as the diluent) of urine that were still bactericidal, were determined for a reference strain and nine uropathogens for which the MICs of gemifloxacin and ofloxacin were as follows:Escherichia coli ATCC 25922, 0.016 and 0.06 μg/ml, respectively; Klebsiella pneumoniae, 0.03 and 0.06 μg/ml, respectively; Proteus mirabilis, 0.125 and 0.125 μg/ml, respectively; Escherichia coli, 0.06 and 0.5 μg/ml, respectively; Pseudomonas aeruginosa, 1 and 4 μg/ml, respectively; Staphylococcus aureus, 0.008 and 0.25 μg/ml, respectively; Enterococcus faecalis, 0.06 and 2 μg/ml, respectively;Staphylococcus aureus, 0.25 and 4 μg/ml, respectively;Enterococcus faecalis, 0.5 and 32 μg/ml, respectively; and Staphylococcus aureus, 2 and 32 μg/ml, respectively. Generally, the UBTs for gram-positive uropathogens were higher for gemifloxacin than for ofloxacin and the UBTs for gram-negative uropathogens were higher for ofloxacin than for gemifloxacin. According to the UBTs, ofloxacin-resistant uropathogens (MICs, ≥4 mg/liter) should also be considered gemifloxacin resistant. Although clinical trials have shown that gemifloxacin is effective for the treatment of uncomplicated urinary tract infections, whether an oral dosage of 320 mg of gemifloxacin once daily is also adequate for the treatment of complicated urinary tract infections has yet to be confirmed.


2021 ◽  
Vol 9 (7) ◽  
pp. 1416
Author(s):  
Karen Leth Nielsen ◽  
Marc Stegger ◽  
Kristoffer Kiil ◽  
Berit Lilje ◽  
Karen Ejrnæs ◽  
...  

Recurrent urinary tract infection (rUTI) remains a major problem for many women and therefore the pursuit for genomic and phenotypic traits which could define rUTI has been ongoing. The present study applied a genomic approach to investigate recurrent urinary tract infections by comparative analyses of recurrent and non-recurrent Escherichia coli isolates from general practice. From whole-genome sequencing data, phylogenetic clustering and genomic traits were studied on a collection of isolates which caused recurrent infection compared to non-recurrent isolates. In addition, genomic variation between the 1st and following infection was studied on a subset of the isolates. Evidence of limited adaptation between the recurrent infections based on single nucleotide polymorphism analyses with a range of 0–13 non-synonymous single nucleotide polymorphisms (SNPs) between the paired isolates. This included an overrepresentation of SNPs in metabolism genes. We identified several genes which were more common in rUTI isolates, including nine fimbrial genes, however, not significantly after false-discovery rate. Finally, the results show that recurrent isolates of the present dataset are not distinctive by variation in the core genome, and thus, did not cluster distinct from non-rUTI isolates in a SNP phylogeny.


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