Ignite Creation Date:
2024-05-06 @ 12:31 AM
Last Modification Date:
2024-10-26 @ 10:51 AM
Study NCT ID:
NCT01595529
Status:
COMPLETED
Last Update Posted:
2020-08-06
First Post:
2012-05-08
Brief Title:
The SCOUT Study Short Course Therapy for Urinary Tract Infections in Children
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Targeted Clinical Trials to Reduce the Risk of Antimicrobial Resistance The SCOUT Study Short Course Therapy for Urinary Tract Infections in Children
Status:
COMPLETED
Status Verified Date:
2013-10-22
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 45 year period 672 will be evaluated for the studys 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 11 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
Detailed Description:
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 studys 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 11 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None