NCT02357758

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

Completed Phase 4 Results posted Last updated 27 August 2021

What this trial tests

Phase 4 trial testing Antibiotic Prophylaxis in Urinary Tract Infection in 59 participants. Completed in 1 March 2016.

Timeline

1 September 2012

Primary endpoint
1 January 2016

1 March 2016

Quick facts

Lead sponsor	London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	basic science
Enrollment	59
Start date	1 September 2012
Primary completion	1 January 2016
Estimated completion	1 March 2016
Sites	1 location across Canada

Drugs / interventions tested

• Antibiotic Prophylaxis — full drug profile →

Conditions studied

• Urinary Tract Infection — all drugs for Urinary Tract Infection →
• Recurrent Urinary Tract Infection — all drugs for Recurrent Urinary Tract Infection →

Sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Who can join

Adults 3 to 15, any sex, with Urinary Tract Infection or Recurrent Urinary Tract Infection. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Changes to the Urinary Microbiota
  Time frame: Baseline, 3-, 6-, 9-, 12-months
  Changes to the urinary microbiota were measured as changes in the colony forming units (CFUs) of Enterococcus sp., Escherichia coli, Klebsiella sp./Enterobacter sp., Staphylococcus saprophyticus, or Pseudomonas sp./Staphylococcus aureus when the participant urine was cultured on CHROMagar Orientation. The data was analyzed in terms of bacterial counts, presence/absence, and presence at or above th

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Enterococcus faecalis persistence in pediatric patients treated with antibiotic prophylaxis for recurrent urinary tract infections.
   Whiteside SA, Dave S, Seney SL, Wang P, et al · · 2018 · cited 7× · PMID 30132694 · DOI 10.2217/fmb-2018-0048