ClinicalTrials.gov
ClinicalTrials.gov Menu

The SCOUT Study: "Short Course Therapy for Urinary Tract Infections in Children"

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01595529
Recruitment Status : Recruiting
First Posted : May 10, 2012
Last Update Posted : March 23, 2018
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

May 8, 2012
May 10, 2012
March 23, 2018
May 18, 2012
June 30, 2019   (Final data collection date for primary outcome measure)
Comparison of efficacy based on symptomatic Urinary Tract Infection (UTI) between short-course and standard-course of antibiotics. [ Time Frame: Day 11 through Day 14 ]
Occurrence of treatment failures between short-course and standard-course therapies [ Time Frame: 12-14 days following initation of therapy ]
Comparison of efficacy, based on symptomatic UTI as assessed up to or at the TOC visit (Day 12-14), between short-course and standard-course therapies.
Complete list of historical versions of study NCT01595529 on ClinicalTrials.gov Archive Site
  • Comparison of number of subjects that have a recurrent infection (includes a relapse UTI or a reinfection) following short-course versus standard-course of antibiotics. [ Time Frame: Day 11 through Day 44 ]
  • Comparison of the number of subjects that become colonized with antimicrobial resistant Escherichia coli (E. coli) and Klebsiella pneumoniae (K. pneumoniae) in the gastrointestinal tract following short-course versus standard course of antibiotics. [ Time Frame: Day 11 through Day 30 ]
  • Comparison of the number of subjects with asymptomatic bacteriuria following short-course versus standard-course of antibiotics. [ Time Frame: Day 11 through Day 14 ]
  • Comparison of the number of subjects with clinical symptoms that may be related to a UTI following short-course versus standard-course of antibiotics. [ Time Frame: Up to Day 14 ]
  • Comparison of the number of subjects with positive urine cultures following short-course versus standard-course of antibiotics. [ Time Frame: Up to Day 14 ]
  • Occurrence of recurrent infections [ Time Frame: 12-14 days following initation of therapy ]
    Comparison of number of subjects that have a recurrent infection (includes a relapse UTI or a reinfection) at any time after the TOC visit (Day 12-14), following short-course versus standard-course (of antibiotics.
  • Occurrence of colonization with antimicrobial resistant bacteria [ Time Frame: 24-26 days following initiation of therapy ]
    Comparison of the number of subjects that become colonized with antimicrobial resistant Escherichia coli (E .coli) and Klebsiella pneumoniae (K. pneumoniae) in the gastrointestinal tract as assessed through Day 24-26, following short-course versus standard course of antibiotics.
  • Occurrence of asymptomatic bacteriuria [ Time Frame: 12-14 days following initiation of therapy ]
    Comparison of the number of subjects with asymptomatic bacteriuria in subjects treated with short-course therapy as compared to the number of subjects treated with standard course therapy at the TOC visit
  • Occurrence of clinical symptoms [ Time Frame: 12-14 days following initiation of therapy ]
    Comparison of the number of subjects with clinical symptoms that may be related to a UTI in subjects treated with short-course therapy as compared to the number of subjects treated with standard course therapy prior to or at the TOC visit.
  • Occurrence of positive urine cultures [ Time Frame: 12-14 days following initiation of therapy ]
    Comparison of the number of subjects with positive urine culture prior to or at TOC between subjects treated with short-course therapy and those treated with standard course therapy.
Not Provided
Not Provided
 
The SCOUT Study: "Short Course Therapy for Urinary Tract Infections in Children"
Targeted Clinical Trials to Reduce the Risk of Antimicrobial Resistance The SCOUT Study: "Short Course Therapy for Urinary Tract Infections in Children"
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).
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.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Urinary Tract Infection
  • Drug: Cefixime
    Cefixime 8 mg/kg/day orally, in 1 dose, with a maximum of 400 mg. Subjects originally receiving Cefdinir will receive Cefixime.
  • Drug: Cephalexin
    Cephalexin 50mg/kg/day in 3 divided doses
  • Other: Placebo
    Placebo to match the other four active treatments
  • Drug: Trimethoprim/Sulfamethoxazole
    8 mg/kg/day of Trimethoprim-sulfamethoxazole (TMP-SMX) orally in 2 divided doses, with a maximum dose of 160 mg twice a day.
  • Experimental: Active treatment
    5 days of active therapy to match the physician-initiated therapy, Trimethoprim sulfamethoxazole, Cefixime or Cefdinir or Cephalexin (subjects originally receiving Cefdinir will receive Cefixime)
    Interventions:
    • Drug: Cefixime
    • Drug: Cephalexin
    • Drug: Trimethoprim/Sulfamethoxazole
  • Placebo Comparator: Placebo treatment
    5 days of placebo treatment to match physician-initiated therapy
    Intervention: Other: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
746
Same as current
December 31, 2019
June 30, 2019   (Final data collection date for primary outcome measure)

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 F or 38 degrees C (measured anywhere on the body) 24 hours prior to the enrollment visit
    • Asymptomatic: report NONE of the following symptoms:

      • Symptoms for all children (ages two months to 10 years):

        ----Fever (a documented temperature of at least 100.4 degrees F OR 38 degrees C measured anywhere on the body)

      • dysuria
    • Additional symptoms for children > 2 years of age:

      • suprapubic, abdominal, or flank pain or tenderness OR
      • urinary urgency, frequency, or hesitancy (defined as an increase in these symptoms from pre-diagnosis conditions)
    • Additional symptoms for children >/= 2 months to 2 years of age:

      • poor feeding OR
      • vomiting
  • Only children who have been prescribed one of the four antibiotics for which a placebo is available will be eligible to participate: TMP-SMX; Cefixime; Cefdinir or Cephalexin. (Note a child that received a one-time dose of I.M. or I.V. medication (i.e. in ER or clinic) prior to starting on the one of the four oral medications is eligible for enrollment)
  • 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
  • A child that is not able to take oral medications
  • Previous surgery of the genitourinary tract (except circumcision in male children)
  • Presence of an immunocompromising condition (e.g., HIV, malignancy, solid-organ transplant recipients, use of chronic corticosteroids or other immunosuppressive agents)
  • Unlikely to complete follow-up (e.g. not available for the two follow-up study visits and the follow-up phone call)
  • A child with a known history of type I hypersensitivity of the study antibiotics to be prescribed
  • Enrollment in another antibiotic study less than 30 days prior to enrollment visit
  • Previous enrollment of individuals in this study
  • Planned enrollment during this study coincides with enrollment in another therapeutic drug study (excluding vaccine)
  • A child with a history of UTI within the past 30 days
  • A child with Grade III-V VUR
  • A child taking antibiotic prophylaxis for any reason
  • A child who has started Day 6 of the originally prescribed antibiotic treatment
Sexes Eligible for Study: All
2 Months to 10 Years   (Child)
No
Contact: Theoklis Zaoutis 12674265570 zaoutis@email.chop.edu
United States
 
 
NCT01595529
09-0103
Not Provided
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Not Provided
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Allergy and Infectious Diseases (NIAID)
Not Provided
Not Provided
National Institute of Allergy and Infectious Diseases (NIAID)
October 22, 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP