CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 59 enrolled
Drug / intervention
Antibiotic Prophylaxisdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02357758
NCT02357758Phase 4Completed

Recurrent Urinary Tract Infections in Children: Bacterial Identification, Antibiotic Susceptibility Profiling and Cytokine Levels Associated With Antibiotic Prophylaxis

In Brief

A Phase 4 clinical trial evaluating Antibiotic Prophylaxis for Urinary Tract Infection and Recurrent Urinary Tract Infection. Completed, enrolled 59 participants across 1 site.

Detailed Summary

Approximately, 3% of males and 8% of females will develop a urinary tract infection (UTI) during childhood, and most of these will be effectively treated by short-term antibiotic therapy. A subset of these children (20-48%), will develop recurrent UTI (RUTI), which may have long-term effects in the form of hypertension or renal damage. In an effort to prevent RUTIs physicians prescribe sulfamethoxazole-trimethoprim (Septra) or nitrofurantoin as low dose antibiotic prophylaxis. However, recent evidence suggests that during prophylactic therapy the body is exposed to antibiotic levels capable of increasing antibiotic resistance and bacterial virulence. This has been shown to be true in the uropathogens E. coli and Staphylococcus saprophyticus, yet it is not known if Enterococcus sp. demonstrate similar mechanisms. Additionally, antibiotics have been shown to disrupt the natural balance of the human microbiome, potentially leading to major long term problems. As a uropathogen, enterococci consistently rank in the top 3 causes of RUTI, especially in children under 3 years of age. Additionally, Enterococcus is notorious for developing antibiotic resistance and studies have shown that children with enterococcal UTIs exhibit a higher rate of recurrence than those with non-enterococcal UTIs. The investigators hypothesize the current practice of antibiotic prophylaxis in children with RUTI is detrimental and can change the bacterial and sensitivity profiles of these patients.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada

Timeline

Phase 4CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedFeb 6, 2015
Enrollment StartSep 1, 2012
Primary CompletionJan 1, 2016
Study CompletionMar 1, 2016
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 11.4 years ago

Interventions

Antibiotic Prophylaxisdrug

Approved clinical dosage or antibiotics