Phase 2
N=693
The SCOUT Study: "Short Course Therapy for Urinary Tract Infections in Children"
Urinary Tract Infection
Bottom Line
View on ClinicalTrials.gov: NCT01595529 ↗Enrolled (actual)
693
Serious AEs
0.9%
Results posted
Jul 2020
Primary outcome: Primary: Comparison of Efficacy Based on Symptomatic Urinary Tract Infection (UTI) Between Short-course and Standard-course of Antibiotics. — 2; 14 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Cefixime (Drug); Cephalexin (Drug); Placebo (Other); Trimethoprim/Sulfamethoxazole (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Primary completion
- Jun 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Comparison of Efficacy Based on Symptomatic Urinary Tract Infection (UTI) Between Short-course and Standard-course of Antibiotics. |
2; 14 | — |
| PRIMARY Comparison of Efficacy Based on Symptomatic Urinary Tract Infection (UTI) Between Short-course and Standard-course of Antibiotics. Per-protocol Population. |
2; 9 | — |
| SECONDARY 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. |
12; 13 | — |
| SECONDARY 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. Per-protocol Population. |
10; 13 | — |
| SECONDARY 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. |
22; 31; 23; 28 | 0.2282 |
| SECONDARY Comparison of the Number of Subjects That Become Colonized With Antimicrobial Resistant E. Coli and K. Pneumoniae in the Gastrointestinal Tract Following Short-course Versus Standard Course of Antibiotics. Per-protocol Population. |
22; 28; 23; 23 | 0.4184 |
| SECONDARY Comparison of the Number of Subjects With Asymptomatic Bacteriuria Following Short-course Versus Standard-course of Antibiotics. |
11; 29 | — |
| SECONDARY Comparison of the Number of Subjects With Asymptomatic Bacteriuria Following Short-course Versus Standard-course of Antibiotics. Per-protocol Population. |
11; 29 | — |
| SECONDARY Comparison of the Number of Subjects With Clinical Symptoms That May be Related to a UTI Following Short-course Versus Standard-course of Antibiotics. |
30; 41 | — |
| SECONDARY Comparison of the Number of Subjects With Clinical Symptoms That May be Related to a UTI Following Short-course Versus Standard-course of Antibiotics. Per-protocol Population |
29; 33 | — |
| SECONDARY Comparison of the Number of Subjects With Positive Urine Cultures Following Short-course Versus Standard-course of Antibiotics. |
6; 41 | — |
| SECONDARY Comparison of the Number of Subjects With Positive Urine Cultures Following Short-course Versus Standard-course of Antibiotics. Per-protocol Population. |
6; 35 | — |
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).
Eligibility Criteria
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:
- 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).
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 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.
Data sourced from ClinicalTrials.gov (NCT01595529). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.