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

Completed · Phase 2 · Has a placebo group

Conditions studied: Urinary Tract Infection

In brief

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).

Key facts

Study ID

NCT01595529

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

717

Starts

2012-05-18

Expected to finish

2019-08-12

Last updated by the study team

2020-08-06

Who can join

Age: 0 and older, up to 10. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• 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
• 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).

You may not qualify if…

• 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 known 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.

Where it is running

• Children's Hospital of Pittsburgh of UPMC - General Academic Pediatric — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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