Urinary Tract Infection | The SCOUT Study: "Short Course Therapy for Urinary Tract Infections in Children"
Urinary Tract Infection research study
What is the primary objective of this study?
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 is eligible to participate?
Inclusion Criteria: 1. 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). 2. Confirmed UTI (Urinary Tract Infection) diagnosis. 3. Documented Clinical Improvement at Randomization. 1. Afebrile: No documented temperature > / = 100.4 degrees Fahrenheit or 38 degrees Celsius (measured anywhere on the body) 24 hours prior to the enrollment visit 2. 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 Fahrenheit OR 38 degrees Celsius 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 4. 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) 5. Parental or guardian permission (informed consent) and if appropriate, child assent (if > / = seven years of age). Exclusion Criteria: 1. 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. 2. A child hospitalized with a UTI that has the following: concomitant bacteremia associated with the UTI, urosepsis, or is in intensive care. 3. A child whose urine culture reveals an organism that is resistant to the initially prescribed antibiotic. 4. A child with a catheter-associated UTI. 5. A child with known anaphylactic allergies to the study products. 6. A child with phenylketonuria (PKU). 7. A child diagnosed with congenital anomalies of the genitourinary tract. 8. UTI in children with known anatomic abnormalities of the genitourinary tract other than VUR (Vesicoureteral reflux), duplicated collection systems, and hydronephrosis. 9. A child that is not able to take oral medications. 10. Previous surgery of the genitourinary tract (except circumcision in male children). 11. Presence of an immunocompromising condition (e.g., HIV, malignancy, solid-organ transplant recipients, use of chronic corticosteroids or other immunosuppressive agents). 12. Unlikely to complete follow-up (e.g. not available for the two follow-up study visits and the follow-up phone call). 13. A child with a known history of type I hypersensitivity of the study antibiotics to be prescribed . 14. Enrollment in another antibiotic study less than 30 days prior to enrollment visit. 15. Previous enrollment of individuals in this study. 16. Planned enrollment during this study coincides with enrollment in another therapeutic drug study (excluding vaccine). 17. A child with a history of UTI within the past 30 days. 18. A child with known Grade III-V VUR. 19. A child taking antibiotic prophylaxis for any reason. 20. A child who has started Day 6 of the originally prescribed antibiotic treatment.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Urinary Tract Infection
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:CefiximeCefixime 8 mg/kg/day orally, in 1 dose, with a maximum of 400 mg. Subjects originally receiving Cefdinir will receive Cefixime.
Drug:CephalexinCephalexin 50mg/kg/day in 3 divided doses
Other:PlaceboPlacebo to match the other four active treatments
Drug:Trimethoprim/Sulfamethoxazole8 mg/kg/day of Trimethoprim-sulfamethoxazole (TMP-SMX) orally in 2 divided doses, with a maximum dose of 160 mg twice a day.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Active treatment5 days of active therapy to match the physician-initiated therapy, Trimethoprim sulfamethoxazole, Cefixime or Cefdinir or Cephalexin (subjects originally receiving Cefdinir will receive Cefixime)
Placebo treatment5 days of placebo treatment to match physician-initiated therapy
Start Date: May 18, 2012
Completed Date: December 31, 2019
Phase: Phase 2
Primary Outcome: Comparison of efficacy based on symptomatic Urinary Tract Infection (UTI) between short-course and standard-course of antibiotics.
Secondary Outcome: 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.
Study sponsors, principal investigator, and references
Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)