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 range2 Months – 10 Years
SexALL
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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.
✓. 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.
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)
. 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.