The SCOUT Study: "Short Course Therapy for Urinary Tract Infections in Children" (NCT01595529) | Clinical Trial Compass
CompletedPhase 2
The SCOUT Study: "Short Course Therapy for Urinary Tract Infections in Children"
United States717 participantsStarted 2012-05-18
Plain-language summary
The SCOUT study is a multi-center, centrally randomized, double-blind, placebo-controlled non-inferiority clinical trial. 746 participants will be enrolled over a 4.5 year period. 672 will be evaluated for the study's primary outcome measure. After the first 5 days of primary care physician initiated antimicrobial therapy, patients who are afebrile and asymptomatic will then be randomized (1:1) to the standard course therapy arm of 5 more days of the same antibiotic therapy or the short course therapy arm of a placebo for 5 more days (for 10 days total). The primary objective of this study is to determine if halting antimicrobial therapy in subjects who have exhibited clinical improvement 5 days after starting antibiotic therapy (short course therapy) have the same failure rate (symptomatic UTI) through visit Day 11-14 as subjects who continue to take antibiotics for an additional 5 days (standard course therapy).
Who can participate
Age range
2 Months – 10 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age at randomization: at least two months (at least 36 weeks gestational age for subjects less than two years of age) to 10 years of age (120 months).
. Confirmed UTI (Urinary Tract Infection) diagnosis.
. Documented Clinical Improvement at Randomization.
. Afebrile: No documented temperature \> / = 100.4 degrees Fahrenheit or 38 degrees Celsius (measured anywhere on the body) 24 hours prior to the enrollment visit
. Asymptomatic: report NONE of the following symptoms:
. Only children who have been prescribed one of the four antibiotics for which a placebo is available will be eligible to participate.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Comparison of Efficacy Based on Symptomatic Urinary Tract Infection (UTI) Between Short-course and Standard-course of Antibiotics.
Timeframe: Day 11 through Day 14
2
Comparison of Efficacy Based on Symptomatic Urinary Tract Infection (UTI) Between Short-course and Standard-course of Antibiotics. Per-protocol Population.
Timeframe: Day 11 through Day 14
Trial details
NCT IDNCT01595529
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
. Parental or guardian permission (informed consent) and if appropriate, child assent (if \> / = seven years of age).
Exclusion criteria
. A urine culture proven infection with a second uropathogen \> 10,000 CFU/mL collected via suprapubic aspiration or catheter or \> 50,000 CFU/mL collected via clean void.
. A child hospitalized with a UTI that has the following: concomitant bacteremia associated with the UTI, urosepsis, or is in intensive care.
. A child whose urine culture reveals an organism that is resistant to the initially prescribed antibiotic.
. A child with a catheter-associated UTI.
. A child with known anaphylactic allergies to the study products.
. A child with phenylketonuria (PKU).
. A child diagnosed with congenital anomalies of the genitourinary tract.
. UTI in children with known anatomic abnormalities of the genitourinary tract other than VUR (Vesicoureteral reflux), duplicated collection systems, and hydronephrosis.