The SCOUT Study: Short Course Therapy for Urinary Tract Infections in Children (SCOUT)
|Urinary Tract Infections||Drug: Trimethoprim sulfamethoxazole, cefixime, or cephalexin Drug: Placebo||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
|Official Title:||Targeted Clinical Trials to Reduce the Risk of Antimicrobial Resistance The SCOUT Study: "Short Course Therapy for Urinary Tract Infections in Children"|
- Occurrence of treatment failures between short-course and standard-course therapies [ Time Frame: 11-14 days following initiation of therapy ]Comparison of efficacy, based on symptomatic UTI as assessed up to or at the TOC visit (Day 11-14), between short-course and standard-course therapies.
- Occurrence of recurrent infections [ Time Frame: 11-14 days following initiation 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 11-14), following short-course versus standard-course (of antibiotics.
- Occurrence of colonization with antimicrobial resistant bacteria [ Time Frame: 24-30 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 24-30, following short-course versus standard course of antibiotics.
- Occurrence of asymptomatic bacteriuria [ Time Frame: 11-14 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: 11-14 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: 11-14 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.
|Study Start Date:||May 2012|
|Estimated Study Completion Date:||April 2018|
|Estimated Primary Completion Date:||April 2018 (Final data collection date for primary outcome measure)|
Active Comparator: Standard course (10 days of active antibiotic)
Five days of continued antibiotic following five days of the antibiotic originally prescribed by the patient's treating clinician. Treatments include: 8 mg/kg/day of Trimethoprim in 2 divided doses (Max 160mg BID); 8 mg/kg/day cefixime in 1 dose (Max 400 mg); 50mg/kg/day cephalexin in 3 divided doses
Drug: Trimethoprim sulfamethoxazole, cefixime, or cephalexin
After five days of active drug, five additional days of one of the following: 1) Oral suspension 200 mg of sulfamethoxazole/40 mg trimethoprim per 5mL. 8 mg/kg/day Trimethoprim in 2 divided doses 2) Reconstituted oral suspension containing 100 mg of cefixime as a trihydrate per 5 mL for small children or 200 mg of cefixime as a trihydrate per 5 mL for large children 3) Reconstituted oral suspension 250mg anhydrous cephalexin per 5mL for small children and two packages of oral suspension of 250mg anhydrous cephalexin per 5mL for large children
Experimental: Short course (5 days of active antibiotic, 5 days of placebo)
Five days of placebo following five days of the antibiotic originally prescribed by the patient's treating clinician.
After five days of active drug, five days of placebo with the same flavoring as active counterpart. Dosage, dosage form, frequency and duration would be matched to each active counterpart.
The standard-of-care to treat uncomplicated UTIs is a 10-day course of antibiotics. Some studies in adults have shown that shorter courses of antibiotics are effective in treating urinary tract infections. The SCOUT Study will determine if five days of antibiotics works as well as 10 days of treatment in children.
In addition, the SCOUT study will determine if the shorter 5-day course of antibiotics is less likely to contribute to antibiotic resistance. The study will try to find out if reducing the antibiotic course to five days of therapy can reduce the chance that antimicrobial resistant bacteria will develop in the gastrointestinal tract. Antibiotics kill the sensitive bacteria but stronger germs may be left to grow and multiply. Antimicrobial resistant bacteria are the bacteria that survive after taking an antibiotic. If these stronger germs grow, the antibiotics may not be as good at killing them.
The study will compare children with urinary tract infections treated with 5 days of antibiotics + five days of placebo (no active medication) versus those treated with 10 full days of antibiotic therapy.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01595529
|Contact: Theoklis Zaoutis, MD, MSCEemail@example.com|
|Contact: Shawn O'Connorfirstname.lastname@example.org|
|United States, Pennsylvania|
|Children's Hospital of Philadelphia||Recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator: Theoklis Zaoutis, MD, MSCE|
|Children's Hospital of Pittsburgh||Recruiting|
|Pittsburgh, Pennsylvania, United States, 15224|
|Contact: Alejandro Hoberman, MD 412-999-3277 email@example.com|
|Contact: Diana Kearney, CCRC 412-692-6717 firstname.lastname@example.org|
|Principal Investigator: Alejandro Hoberman, MD|
|Principal Investigator:||Theoklis Zaoutis, MD, MSCE||Children's Hospital of Philadelphia|