The SCOUT Study: "Short Course Therapy for Urinary Tract Infections in Children"
Condition: Urinary Tract Infection
MeSH terms: Infections; Communicable Diseases; Urinary Tract Infections
Study type: Interventional
Phase: Phase 2

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).
    

Detailed description: 
      The SCOUT Study is a multi-center, centrally randomized, double-blind, placebo-controlled
      non-inferiority clinical trial of 746 children ages two months (at least 36 weeks gestation
      from birth for subjects < two years of age) to 10 years with a confirmed diagnosis of a
      urinary tract infection (UTI) to evaluate 672 for the study's primary outcome measure. UTI is
      one of the most common serious bacterial infections during childhood. Escherichia coli (E.
      coli) isolates account for 80-90 percent of all outpatient UTIs in children. Although
      antibiotics are the first treatment choice for urinary tract infections, antibiotic-resistant
      strains of E. coli, the most common cause of UTIs, are increasing worldwide. The study will
      enroll 746 children who have demonstrated clinical improvement five days after starting the
      originally prescribed antibiotic (afebrile and asymptomatic) and they will be randomized
      either to the standard-course arm or the short-course arm at a 1:1 ratio. Subjects will be
      enrolled over approximately a four and a half year period. Study duration for each individual
      subject will be approximately five weeks. The study product will consist of
      trimethoprim-sulfamethoxazole (TMP-SMX), cefixime, cefdinir, cephalexin and the corresponding
      placebos. 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). The secondary objectives are: 1) to determine if short-course therapy compared to
      standard course therapy results in similar numbers of children experiencing a recurrent
      urinary tract infection (relapse and reinfection; 2) to determine if short-course therapy
      compared to standard course therapy results in similar numbers of children with asymptomatic
      bacteriuria; 3) to determine if short-course therapy compared to standard course therapy
      results in similar numbers of children with gastrointestinal colonization of antimicrobial
      resistant Escherichia coli (E. coli) and Klebsiella pneumonia (K. pneumoniae); 4) to
      determine if short-course therapy compared to standard course therapy results in similar
      numbers of subjects presenting with clinical symptoms that may be related to UTI; 5) to
      determine if the number of subjects with positive urine culture prior to or at visit Day
      11-14 is similar after short-course therapy compared to standard course therapy.
    

Intervention name(s): Cefixime; Cephalexin; Placebo; Trimethoprim/Sulfamethoxazole
Intervention type(s): Drug; Drug; Other; Drug
Intervention description(s): Cefixime 8 mg/kg/day orally, in 1 dose, with a maximum of 400 mg. Subjects originally receiving Cefdinir will receive Cefixime.; Cephalexin 50mg/kg/day in 3 divided doses; Placebo to match the other four active treatments; 8 mg/kg/day of Trimethoprim-sulfamethoxazole (TMP-SMX) orally in 2 divided doses, with a maximum dose of 160 mg twice a day.
Intervention MeSH terms: Trimethoprim; Sulfamethoxazole; Cephalexin; Cefixime
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: antibiotic therapy; antimicrobial resistance; children; E.coli; K.pneumoniae; parent study; SCOUT Study; spectrum stool bacteria; stool culture; urinary tract infections