Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT01140516 |
| Other study ID # |
ALPHA |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 2010 |
| Est. completion date |
September 2024 |
Study information
| Verified date |
October 2023 |
| Source |
McMaster University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This study focuses on the relationship between prophylaxis antibiotics and frequency of
urinary tract infection in children diagnosed with antenatal hydronephrosis. Hydronephrosis
is the most common fetal abnormality occurring in 1-5% of all pregnancies. Currently, with
the widespread accessibility of antenatal ultrasound across cities in Ontario, the detection
of hydronephrosis has become even more common. As a result, thousands of infants with
hydronephrosis have been seen and managed by pediatricians, pediatric nephrologists,
pediatric urologists, and family physicians. The investigators need to determine if
antibiotic prophylaxis is effective in reducing the number of urinary tract infections in
this population.
Description:
This study focuses on the relationship between prophylaxis antibiotics and frequency of
urinary tract infection in children diagnosed with antenatal hydronephrosis. Hydronephrosis
is the most common fetal abnormality occurring in 1-5% of all pregnancies. Currently, with
the widespread accessibility of antenatal ultrasound across cities in Ontario, the detection
of hydronephrosis has become even more common. As a result, thousands of infants with
hydronephrosis have been seen and managed by pediatricians, pediatric nephrologists,
pediatric urologists, and family physicians. The investigators need to determine if
antibiotic prophylaxis is effective in reducing the number of urinary tract infections in
this population.To determine whether CAP reduces the rate of UTI in infants with prenatal HN
within the first 18 months of life.
This is superiority, parallel, blinded, randomized, placebo-controlled trial in infants with
prenatal HN testing the effect of CAP on febrile UTI rates over the first 18 months of life
For clinical and safety purposes, data will be collected on symptoms and signs of febrile
laboratory confirmed UTI (urinalysis, urine culture), compliance to treatment, adverse
effects, and resistance to prophylactic antibiotics in case of positive urine cultures. As
part of standard medical care, the patient and family are scheduled for renal-bladder
ultrasounds and outpatient pediatric urology clinic visits at the local recruitment sites
(i.e. McMaster Children's Hospital, The Hospital for Sick Children or, Children's Hospital of
Eastern Ontario) during months as mentioned above at baseline, 3, 6, 9 and 12 months . During
these clinic appointments, the research coordinator will follow up with patient and family
regarding their progress in the study. The Research Coordinator will ask about any side
effects from trial medication (nausea, vomiting, gastroenteritis, anaphylactic reactions) and
ensure their questions or concerns are addressed. Data from patient's ultrasound assessment
and renal scans will also be collected.
In addition to clinic follow ups, patients and their families will be contacted monthly
(excluding the months patient is scheduled for clinical follow up) by the Research
Coordinator to further monitor patient's study progress. Families will be instructed to call
the Research Coordinator at the first sign of febrile UTI (fever, loss of appetite, abdominal
pain) and advised to seek medical assistance (bring their child to the Emergency Department
at the local study institution). The baby will then have a dipstick taken to test for
positive nitrites and leukocytes. If positive, patients are to have a urine sample via
catheter specimen taken and if positive, be taken off study medication and be treated for
febrile UTI according to standard medical practice. In this case the family and healthcare
providers will not be unblinded to the participant's treatment allocation as this information
is not required in order to treat the infant. In the event that parents are unable to bring
their child to the local study institution, it is advised they obtain a dipstick and a
catheter specimen from their local walk-in-clinic, Urgent Care Centre or family physician's
office. If a catheter specimen is not available at these locations, a sterile bag may be used
to determine outcome of urine sample. To ensure there is consistency between outside
facilities, parents are given detailed instructions to obtain a dipstick and provide a
photocopy of the results to the Research Coordinator for our records and potential
adjudication.
Letters will be faxed to the doctor that treated the child for the suspected UTI in order to
obtain the associated reports.
