Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

Patients meeting the inclusion criteria will be recruited to the study at Dr. Dave's discretion through the urology clinic. As clinically indicated patients will then fall into one of two groups, patients receiving antibiotic prophylaxis or those undergoing clinical observation. This reflects the standard of care these children receive and no additional procedures are mandated. At the initial appointment information sheets and consent forms will be given to the parent/caregiver to consider; due to the nature of the study, the parent or legal guardian will be required to give informed consent. Following the receipt of informed consent, patients will be asked to provide a mid stream urine sample given they are infection free and not currently on antibiotics. Patients will be assessed simultaneously for dysfunctional elimination syndrome (DES) through review of their 48-hour bowel bladder diary, the completed Dysfunctional Voiding Scoring System (DVSS) questionnaire and performing uroflowmetry. Patients may withdraw from the study at any stage without repercussion. Patients in the antibiotic prophylaxis group will receive a 3-month script for antibiotic prophylaxis, if clinically indicated according to the standard of care. Septra (Trimethoprim dose 2 mg/kg) or nitrofurantoin (dose 2 mg/kg) will be the antibiotics used for prophylaxis based on past cultures or allergy history. Antibiotic prescription will be renewed at 3 months and an informal assessment on compliance will be performed through review of the number of doses left. Patients not tolerating one of these antibiotics will be offered the alternate. From months 6-12, prophylaxis will cease (washout period) unless a symptomatic UTI is suspected at which point appropriate treatment will be implemented. Lifestyle changes, behavioural modification and management of constipation will be instituted in both groups. Patients will return for follow up visits at 3, 6, 9 and 12 months. In addition, patients can return to the urology clinic at any time if UTI is suspected. Urine samples will be collected at baseline and at 3, 6, 9 and 12 months from both groups (prophylaxis versus observation) by registered nurses at Children's Hospital, London Health Sciences Centre. Healthy patients, those with no recent history of UTI or antibiotic use or known urinary tract abnormalities, will be included to give an indication of the healthy urinary microbiota in the paediatric population. These participants will be asked to provide urine at two time points a minimum of three months apart. Samples will be assessed for bacterial identification via both culture dependent and independent methods. Antibiotic susceptibility profiles will be determined for viable organisms using the Kirby Bauer disk method and bacterial virulence analyzed via bladder and kidney cell line adherence and internalization assays, as well as PCR to determine the presence of virulence genes associated with the pathogen (adhesins, fimbriae, toxins). Urinary cytokine analysis via Luminex will also be conducted as a measure of host bladder state, immune response and disease severity. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02357758
Study type Interventional
Source Lawson Health Research Institute
Contact
Status Completed
Phase Phase 4
Start date September 2012
Completion date March 2016

See also
  Status Clinical Trial Phase
Completed NCT03235947 - Perioperative Fosfomycin in the Prophylaxis of Urinary Tract Infection in Kidney Transplant Recipients Phase 4
Terminated NCT02198833 - Efficacy of Micro-Patterned Foley Catheter to Reduce Catheter-Associated Urinary Tract Infection N/A
Withdrawn NCT01881165 - Cranberry on Urinary Tract Infections Phase 4
Completed NCT01687114 - Urinary Proanthocyanidin-A2 as a Biomarker of Compliance to Intake of Cranberry Products N/A
Completed NCT01391793 - Corticosteroids for Children With Febrile Urinary Tract Infections Phase 3
Completed NCT01219595 - Cranberry Proanthocyanidins for Modification of Intestinal E. Coli Flora and Prevention of Urinary Tract Infections in UTI-Susceptible Women N/A
Completed NCT00365430 - SAFE or SORRY? Patient Safety Study of the Prevention of Adverse Patient Outcomes N/A
Recruiting NCT04502095 - Prophylactic Antibiotics for Urinary Tract Infections After Robot-Assisted Radical Cystectomy Phase 4
Completed NCT00976963 - Single Dose Monurol for Treatment of Acute Cystitis N/A
Recruiting NCT02568800 - Prolonged Infusion Cefepime and Nosocomial Infections Phase 3
Completed NCT02785445 - Healthy.io Method Comparison & User Performance Study N/A
Completed NCT02216253 - L-methionine, Hibiscus Sabdariffa and Boswellia Leaf Extract to Prevent Postoperative Urinary Tract Infection. N/A
Completed NCT01478620 - Safety and Efficacy of Canephron® N in the Management of Uncomplicated Urinary Tract Infections (uUTI) Phase 3
Completed NCT01054690 - Silver Alloyed Urinary Catheters and Incidence of Catheter Acquired Urinary Tract Infections (UTI) N/A
Completed NCT00371631 - Colonizing Neurogenic Bladders With Benign Flora Phase 1
Terminated NCT03697993 - Safety and Efficacy Study of Oral Fosfomycin Versus Oral Levofloxacin to Treat Complicated Urinary Syndromes (FOCUS) Phase 4
Terminated NCT01803919 - Efficacy Study of Antimicrobial Catheters to Avoid Urinary Infections in Spinal Cord Injured Patients N/A
Enrolling by invitation NCT01231737 - Efficacy of Two Prophylactic Schedules (Prulifloxacin Versus Phosphomycin) Phase 2
Completed NCT01763008 - A Study of the Safety and Effectiveness of Doripenem in Filipino Patients With Nosocomial Pneumonia, Complicated Intra-Abdominal Infections and Complicated Urinary Tract Infections Phase 4
Completed NCT00528476 - Risk Factors for Recurrent Urinary Tract Infection in Children N/A