Phase 4
N=57
Effects of Antibiotic Prophylaxis on Recurrent UTI in Children
Urinary Tract Infection · Recurrent Urinary Tract Infection
Bottom Line
View on ClinicalTrials.gov: NCT02357758 ↗Enrolled (actual)
57
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcome: Primary: Changes to the Urinary Microbiota — 3; 2; 1 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Antibiotic Prophylaxis (Drug)
- Age
- Pediatric · 3+ yrs
- Sex
- All
- Sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Primary completion
- Jan 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes to the Urinary Microbiota |
3; 2; 1 | — |
| SECONDARY Changes to Metabolic Profiles of Urine |
— | — |
| SECONDARY Changes to Antibiotic Susceptibility |
— | — |
| SECONDARY Changes in Pro-inflammatory Cytokines |
— | — |
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.
Eligibility Criteria
Inclusion Criteria
- Patient has experienced a minimum of 2 UTIs within the last year, as well as a culture proven UTI for inclusion into either of the RUTI groups.
- Patients must be deemed to require antibiotic prophylaxis, at the discretion of Dr. Dave and following the standard of care, for inclusion in the antibiotic prophylaxis group.
- Patients with no known urological abnormalities, recent history of UTI or antibiotic use are eligible for inclusion in the healthy patient group.
Exclusion Criteria
- Patients with an abnormal urinary tract as determined through the use of ultrasound and, given an abnormal ultrasound, or greater than two febrile UTIs, a voiding cystourethrogram (VCUG). The use of both ultrasound and VCUG given these indications is standard of care.
Data sourced from ClinicalTrials.gov (NCT02357758). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.