Trial Outcomes & Findings for The SCOUT Study: "Short Course Therapy for Urinary Tract Infections in Children" (NCT NCT01595529)
NCT ID: NCT01595529
Last Updated: 2020-08-06
Results Overview
A subject will be categorized as a treatment failure, if he/she has a symptomatic UTI in period between Day 6 through the Day 11 - 14 Test of Cure (TOC) Visit: 1. Symptoms * Symptoms for all subjects (ages two months to 10 years): fever (a documented temperature of at least 100.4 °F OR 38°C measured anywhere on the body) ,dysuria * Additional symptoms for subjects \> 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 subjects = 2 months to 2 years of age: poor feeding OR vomiting AND 2. Pyuria on urinalysis AND 3. Culture proven infection with a single uropathogen NOTE: As per the above criteria, asymptomatic subjects (including subjects assessed as having asymptomatic bacteriuria) at the Day 11-14 TOC visit will NOT be considered a treatment failure for the primary outcome measure.
COMPLETED
PHASE2
717 participants
Day 11 through Day 14
2020-08-06
Participant Flow
Of the 717 enrolled, 23 did not meet the screening criteria and 1 withdrew consent prior to randomization. 693 subjects were randomized.
Participant milestones
| Measure |
Standard Course Treatment
5 days of active therapy to match the physician-initiated therapy, Trimethoprim sulfamethoxazole, Cefixime or Cefdinir or Cephalexin (subjects originally receiving Cefdinir will receive Cefixime)
Cefixime: Cefixime 8 mg/kg/day orally, in 1 dose, with a maximum of 400 mg. Subjects originally receiving Cefdinir will receive Cefixime.
Cephalexin: Cephalexin 50mg/kg/day in 3 divided doses
Trimethoprim/Sulfamethoxazole: 8 mg/kg/day of Trimethoprim-sulfamethoxazole (TMP-SMX) orally in 2 divided doses, with a maximum dose of 160 mg twice a day.
|
Short Course Treatment
5 days of placebo treatment to match physician-initiated therapy
Placebo: Placebo to match the other four active treatments
|
|---|---|---|
|
Overall Study
STARTED
|
348
|
345
|
|
Overall Study
Treated
|
337
|
340
|
|
Overall Study
Evaluated for Primary Endpoint, ITT
|
328
|
336
|
|
Overall Study
ITT Without Treatment Failure
|
326
|
322
|
|
Overall Study
ITT With Stool Sample at TOC
|
298
|
310
|
|
Overall Study
Per-protocol, Completed 80% of Dose
|
308
|
314
|
|
Overall Study
Per-protocol Without Treatment Failure
|
306
|
305
|
|
Overall Study
Per-protocol With Stool Sample at TOC
|
280
|
289
|
|
Overall Study
Completed All Milestones
|
318
|
318
|
|
Overall Study
COMPLETED
|
324
|
325
|
|
Overall Study
NOT COMPLETED
|
24
|
20
|
Reasons for withdrawal
| Measure |
Standard Course Treatment
5 days of active therapy to match the physician-initiated therapy, Trimethoprim sulfamethoxazole, Cefixime or Cefdinir or Cephalexin (subjects originally receiving Cefdinir will receive Cefixime)
Cefixime: Cefixime 8 mg/kg/day orally, in 1 dose, with a maximum of 400 mg. Subjects originally receiving Cefdinir will receive Cefixime.
Cephalexin: Cephalexin 50mg/kg/day in 3 divided doses
Trimethoprim/Sulfamethoxazole: 8 mg/kg/day of Trimethoprim-sulfamethoxazole (TMP-SMX) orally in 2 divided doses, with a maximum dose of 160 mg twice a day.
|
Short Course Treatment
5 days of placebo treatment to match physician-initiated therapy
Placebo: Placebo to match the other four active treatments
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
0
|
|
Overall Study
Subject Non-Compliant
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
8
|
14
|
|
Overall Study
Protocol Violation
|
1
|
2
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Consent Withdrawn/Voluntary Withdrawal
|
3
|
3
|
|
Overall Study
Administrative Decision
|
1
|
0
|
|
Overall Study
Entry Failure/Screening Failure
|
6
|
1
|
Baseline Characteristics
The SCOUT Study: "Short Course Therapy for Urinary Tract Infections in Children"
Baseline characteristics by cohort
| Measure |
Standard Course Treatment
n=328 Participants
5 days of active therapy to match the physician-initiated therapy, Trimethoprim sulfamethoxazole, Cefixime or Cefdinir or Cephalexin (subjects originally receiving Cefdinir will receive Cefixime)
Cefixime: Cefixime 8 mg/kg/day orally, in 1 dose, with a maximum of 400 mg. Subjects originally receiving Cefdinir will receive Cefixime.
Cephalexin: Cephalexin 50mg/kg/day in 3 divided doses
Trimethoprim/Sulfamethoxazole: 8 mg/kg/day of Trimethoprim-sulfamethoxazole (TMP-SMX) orally in 2 divided doses, with a maximum dose of 160 mg twice a day.
|
Short Course Treatment
n=336 Participants
5 days of placebo treatment to match physician-initiated therapy
Placebo: Placebo to match the other four active treatments
|
Total
n=664 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
4.31 years
STANDARD_DEVIATION 2.71 • n=5 Participants
|
4.16 years
STANDARD_DEVIATION 2.62 • n=7 Participants
|
4.23 years
STANDARD_DEVIATION 2.66 • n=5 Participants
|
|
Age, Customized
Age · 2 months - 35 months
|
95 Participants
n=5 Participants
|
89 Participants
n=7 Participants
|
184 Participants
n=5 Participants
|
|
Age, Customized
Age · 3 - 6 years
|
148 Participants
n=5 Participants
|
177 Participants
n=7 Participants
|
325 Participants
n=5 Participants
|
|
Age, Customized
Age · 7 - 10 years
|
85 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
155 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
316 Participants
n=5 Participants
|
323 Participants
n=7 Participants
|
639 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
217 Participants
n=5 Participants
|
210 Participants
n=7 Participants
|
427 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Black/African American
|
73 Participants
n=5 Participants
|
83 Participants
n=7 Participants
|
156 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Native Hawaiian/Other Pacific Islander
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · American Indian/Alaska Native
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Multi-Racial
|
23 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Unknown
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Hispanic
|
33 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Not Hispanic
|
295 Participants
n=5 Participants
|
309 Participants
n=7 Participants
|
604 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 11 through Day 14Population: Intent to treat population, ITT. All subjects taking at least one dose of study treatment between Day 6 and Day 10 who have been evaluated for treatment success at TOC or have failed prior to TOC.
A subject will be categorized as a treatment failure, if he/she has a symptomatic UTI in period between Day 6 through the Day 11 - 14 Test of Cure (TOC) Visit: 1. Symptoms * Symptoms for all subjects (ages two months to 10 years): fever (a documented temperature of at least 100.4 °F OR 38°C measured anywhere on the body) ,dysuria * Additional symptoms for subjects \> 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 subjects = 2 months to 2 years of age: poor feeding OR vomiting AND 2. Pyuria on urinalysis AND 3. Culture proven infection with a single uropathogen NOTE: As per the above criteria, asymptomatic subjects (including subjects assessed as having asymptomatic bacteriuria) at the Day 11-14 TOC visit will NOT be considered a treatment failure for the primary outcome measure.
Outcome measures
| Measure |
Standard Course Treatment
n=328 Participants
5 days of active therapy to match the physician-initiated therapy, Trimethoprim sulfamethoxazole, Cefixime or Cefdinir or Cephalexin (subjects originally receiving Cefdinir will receive Cefixime)
Cefixime: Cefixime 8 mg/kg/day orally, in 1 dose, with a maximum of 400 mg. Subjects originally receiving Cefdinir will receive Cefixime.
Cephalexin: Cephalexin 50mg/kg/day in 3 divided doses
Trimethoprim/Sulfamethoxazole: 8 mg/kg/day of Trimethoprim-sulfamethoxazole (TMP-SMX) orally in 2 divided doses, with a maximum dose of 160 mg twice a day.
|
Short Course Treatment
n=336 Participants
5 days of placebo treatment to match physician-initiated therapy
Placebo: Placebo to match the other four active treatments
|
|---|---|---|
|
Comparison of Efficacy Based on Symptomatic Urinary Tract Infection (UTI) Between Short-course and Standard-course of Antibiotics.
|
2 Participants
|
14 Participants
|
PRIMARY outcome
Timeframe: Day 11 through Day 14Population: Per-protocol Population (PP): The enrolled subjects who were adherent to their assigned study regimen and completed more than 80% of the prescribed dose between Day 6 and Day 10 (per-protocol population).
A subject will be categorized as a treatment failure, if he/she has a symptomatic UTI in period between Day 6 through the Day 11 - 14 Test of Cure (TOC) Visit: 1. Symptoms * Symptoms for all subjects (ages two months to 10 years): fever (a documented temperature of at least 100.4 °F OR 38°C measured anywhere on the body) ,dysuria * Additional symptoms for subjects \> 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 subjects = 2 months to 2 years of age: poor feeding OR vomiting AND 2. Pyuria on urinalysis AND 3. Culture proven infection with a single uropathogen NOTE: As per the above criteria, asymptomatic subjects (including subjects assessed as having asymptomatic bacteriuria) at the Day 11-14 TOC visit will NOT be considered a treatment failure for the primary outcome measure.
Outcome measures
| Measure |
Standard Course Treatment
n=308 Participants
5 days of active therapy to match the physician-initiated therapy, Trimethoprim sulfamethoxazole, Cefixime or Cefdinir or Cephalexin (subjects originally receiving Cefdinir will receive Cefixime)
Cefixime: Cefixime 8 mg/kg/day orally, in 1 dose, with a maximum of 400 mg. Subjects originally receiving Cefdinir will receive Cefixime.
Cephalexin: Cephalexin 50mg/kg/day in 3 divided doses
Trimethoprim/Sulfamethoxazole: 8 mg/kg/day of Trimethoprim-sulfamethoxazole (TMP-SMX) orally in 2 divided doses, with a maximum dose of 160 mg twice a day.
|
Short Course Treatment
n=314 Participants
5 days of placebo treatment to match physician-initiated therapy
Placebo: Placebo to match the other four active treatments
|
|---|---|---|
|
Comparison of Efficacy Based on Symptomatic Urinary Tract Infection (UTI) Between Short-course and Standard-course of Antibiotics. Per-protocol Population.
|
2 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Day 11 through Day 44Population: Subjects in the ITT population who did not experience a treatment failure.
Outcome measures
| Measure |
Standard Course Treatment
n=326 Participants
5 days of active therapy to match the physician-initiated therapy, Trimethoprim sulfamethoxazole, Cefixime or Cefdinir or Cephalexin (subjects originally receiving Cefdinir will receive Cefixime)
Cefixime: Cefixime 8 mg/kg/day orally, in 1 dose, with a maximum of 400 mg. Subjects originally receiving Cefdinir will receive Cefixime.
Cephalexin: Cephalexin 50mg/kg/day in 3 divided doses
Trimethoprim/Sulfamethoxazole: 8 mg/kg/day of Trimethoprim-sulfamethoxazole (TMP-SMX) orally in 2 divided doses, with a maximum dose of 160 mg twice a day.
|
Short Course Treatment
n=322 Participants
5 days of placebo treatment to match physician-initiated therapy
Placebo: Placebo to match the other four active treatments
|
|---|---|---|
|
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 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: Day 11 through Day 44Population: Subjects in the per-protocol population who did not experience a treatment failure.
Outcome measures
| Measure |
Standard Course Treatment
n=306 Participants
5 days of active therapy to match the physician-initiated therapy, Trimethoprim sulfamethoxazole, Cefixime or Cefdinir or Cephalexin (subjects originally receiving Cefdinir will receive Cefixime)
Cefixime: Cefixime 8 mg/kg/day orally, in 1 dose, with a maximum of 400 mg. Subjects originally receiving Cefdinir will receive Cefixime.
Cephalexin: Cephalexin 50mg/kg/day in 3 divided doses
Trimethoprim/Sulfamethoxazole: 8 mg/kg/day of Trimethoprim-sulfamethoxazole (TMP-SMX) orally in 2 divided doses, with a maximum dose of 160 mg twice a day.
|
Short Course Treatment
n=305 Participants
5 days of placebo treatment to match physician-initiated therapy
Placebo: Placebo to match the other four active treatments
|
|---|---|---|
|
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 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: Day 11 through Day 30Population: Subjects in the ITT population who have a stool sample at TOC visit. Some treatment failures will not have a sample collected at TOC because they failed prior to TOC. Treatment failures without the sample at TOC are excluded.
A child would have emergent antibiotic resistance if they: 1. Had no antibiotic-resistant E.coli or K.pneumoniae at enrollment but one or both are now present. OR 2. Had either antibiotic-resistant E.coli or K.pneumoniae at enrollment but now the other antibiotic-resistant organism is present OR 3. Had antibiotic-resistant E.coli and/or K.pneumoniae at enrollment, but have now developed resistance to new antibiotics in either organism.
Outcome measures
| Measure |
Standard Course Treatment
n=298 Participants
5 days of active therapy to match the physician-initiated therapy, Trimethoprim sulfamethoxazole, Cefixime or Cefdinir or Cephalexin (subjects originally receiving Cefdinir will receive Cefixime)
Cefixime: Cefixime 8 mg/kg/day orally, in 1 dose, with a maximum of 400 mg. Subjects originally receiving Cefdinir will receive Cefixime.
Cephalexin: Cephalexin 50mg/kg/day in 3 divided doses
Trimethoprim/Sulfamethoxazole: 8 mg/kg/day of Trimethoprim-sulfamethoxazole (TMP-SMX) orally in 2 divided doses, with a maximum dose of 160 mg twice a day.
|
Short Course Treatment
n=310 Participants
5 days of placebo treatment to match physician-initiated therapy
Placebo: Placebo to match the other four active treatments
|
|---|---|---|
|
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.
Test of Cure Visit (Day 11-14)
|
22 Participants
|
31 Participants
|
|
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.
Outcome Assessment Visit (Day 24-30)
|
23 Participants
|
28 Participants
|
SECONDARY outcome
Timeframe: Day 11 through Day 30Population: Subjects in the ITT population who have a stool sample at TOC visit. Some treatment failures will not have a sample collected at TOC because they failed prior to TOC. Treatment failures without the sample at TOC would be excluded from the Antibiotic Resistant ITT population.
A child would have emergent antibiotic resistance if they: 1. Had no antibiotic-resistant E.coli or K.pneumoniae at enrollment but one or both are now present. OR 2. Had either antibiotic-resistant E.coli or K.pneumoniae at enrollment but now the other antibiotic-resistant organism is present OR 3. Had antibiotic-resistant E.coli and/or K.pneumoniae at enrollment, but have now developed resistance to new antibiotics in either organism.
Outcome measures
| Measure |
Standard Course Treatment
n=280 Participants
5 days of active therapy to match the physician-initiated therapy, Trimethoprim sulfamethoxazole, Cefixime or Cefdinir or Cephalexin (subjects originally receiving Cefdinir will receive Cefixime)
Cefixime: Cefixime 8 mg/kg/day orally, in 1 dose, with a maximum of 400 mg. Subjects originally receiving Cefdinir will receive Cefixime.
Cephalexin: Cephalexin 50mg/kg/day in 3 divided doses
Trimethoprim/Sulfamethoxazole: 8 mg/kg/day of Trimethoprim-sulfamethoxazole (TMP-SMX) orally in 2 divided doses, with a maximum dose of 160 mg twice a day.
|
Short Course Treatment
n=289 Participants
5 days of placebo treatment to match physician-initiated therapy
Placebo: Placebo to match the other four active treatments
|
|---|---|---|
|
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.
Test of Cure Visit (Day 11-14)
|
22 Participants
|
28 Participants
|
|
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.
Outcome Assessment Visit (Day 24-30)
|
23 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: Day 11 through Day 14Population: Intent-to-treat (ITT) Population: All subjects taking at least one dose of study treatment between Day 6 and Day 10 who have been evaluated for treatment success at TOC or have failed prior to TOC.
Asymptomatic Bacteriuria is defined in any SCOUT subject by: 1. Absence of symptoms attributable to UTI including fever AND/OR the following: * Symptoms for all children (ages two months to 10 years): * fever (a documented temperature of at least 100.4 °F OR 38°C 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 AND 2. A positive urine culture * 5 x 104 CFU/mL (catheterized or suprapubic aspiration urine specimen) OR * \>105 CFU/mL (clean void specimen).
Outcome measures
| Measure |
Standard Course Treatment
n=328 Participants
5 days of active therapy to match the physician-initiated therapy, Trimethoprim sulfamethoxazole, Cefixime or Cefdinir or Cephalexin (subjects originally receiving Cefdinir will receive Cefixime)
Cefixime: Cefixime 8 mg/kg/day orally, in 1 dose, with a maximum of 400 mg. Subjects originally receiving Cefdinir will receive Cefixime.
Cephalexin: Cephalexin 50mg/kg/day in 3 divided doses
Trimethoprim/Sulfamethoxazole: 8 mg/kg/day of Trimethoprim-sulfamethoxazole (TMP-SMX) orally in 2 divided doses, with a maximum dose of 160 mg twice a day.
|
Short Course Treatment
n=336 Participants
5 days of placebo treatment to match physician-initiated therapy
Placebo: Placebo to match the other four active treatments
|
|---|---|---|
|
Comparison of the Number of Subjects With Asymptomatic Bacteriuria Following Short-course Versus Standard-course of Antibiotics.
|
11 Participants
|
29 Participants
|
SECONDARY outcome
Timeframe: Day 11 through Day 14Population: Per-protocol Population (PP): The enrolled subjects who were adherent to their assigned study regimen and completed more than 80% of the prescribed dose between Day 6 and Day 10 (per-protocol population).
Asymptomatic Bacteriuria is defined in any SCOUT subject by: 1. Absence of symptoms attributable to UTI including fever AND/OR the following: * Symptoms for all children (ages two months to 10 years): * fever (a documented temperature of at least 100.4 °F OR 38°C 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 AND 2. A positive urine culture * 5 x 104 CFU/mL (catheterized or suprapubic aspiration urine specimen) OR * \>105 CFU/mL (clean void specimen).
Outcome measures
| Measure |
Standard Course Treatment
n=308 Participants
5 days of active therapy to match the physician-initiated therapy, Trimethoprim sulfamethoxazole, Cefixime or Cefdinir or Cephalexin (subjects originally receiving Cefdinir will receive Cefixime)
Cefixime: Cefixime 8 mg/kg/day orally, in 1 dose, with a maximum of 400 mg. Subjects originally receiving Cefdinir will receive Cefixime.
Cephalexin: Cephalexin 50mg/kg/day in 3 divided doses
Trimethoprim/Sulfamethoxazole: 8 mg/kg/day of Trimethoprim-sulfamethoxazole (TMP-SMX) orally in 2 divided doses, with a maximum dose of 160 mg twice a day.
|
Short Course Treatment
n=314 Participants
5 days of placebo treatment to match physician-initiated therapy
Placebo: Placebo to match the other four active treatments
|
|---|---|---|
|
Comparison of the Number of Subjects With Asymptomatic Bacteriuria Following Short-course Versus Standard-course of Antibiotics. Per-protocol Population.
|
11 Participants
|
29 Participants
|
SECONDARY outcome
Timeframe: Up to Day 14Population: Intent-to-treat (ITT) Population: All subjects taking at least one dose of study treatment between Day 6 and Day 10 who have been evaluated for treatment success at TOC or have failed prior to TOC.
Outcome measures
| Measure |
Standard Course Treatment
n=328 Participants
5 days of active therapy to match the physician-initiated therapy, Trimethoprim sulfamethoxazole, Cefixime or Cefdinir or Cephalexin (subjects originally receiving Cefdinir will receive Cefixime)
Cefixime: Cefixime 8 mg/kg/day orally, in 1 dose, with a maximum of 400 mg. Subjects originally receiving Cefdinir will receive Cefixime.
Cephalexin: Cephalexin 50mg/kg/day in 3 divided doses
Trimethoprim/Sulfamethoxazole: 8 mg/kg/day of Trimethoprim-sulfamethoxazole (TMP-SMX) orally in 2 divided doses, with a maximum dose of 160 mg twice a day.
|
Short Course Treatment
n=336 Participants
5 days of placebo treatment to match physician-initiated therapy
Placebo: Placebo to match the other four active treatments
|
|---|---|---|
|
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 Participants
|
41 Participants
|
SECONDARY outcome
Timeframe: Up to Day 14Population: Per-protocol Population (PP): The enrolled subjects who were adherent to their assigned study regimen and completed more than 80% of the prescribed dose between Day 6 and Day 10 (per-protocol population).
Outcome measures
| Measure |
Standard Course Treatment
n=308 Participants
5 days of active therapy to match the physician-initiated therapy, Trimethoprim sulfamethoxazole, Cefixime or Cefdinir or Cephalexin (subjects originally receiving Cefdinir will receive Cefixime)
Cefixime: Cefixime 8 mg/kg/day orally, in 1 dose, with a maximum of 400 mg. Subjects originally receiving Cefdinir will receive Cefixime.
Cephalexin: Cephalexin 50mg/kg/day in 3 divided doses
Trimethoprim/Sulfamethoxazole: 8 mg/kg/day of Trimethoprim-sulfamethoxazole (TMP-SMX) orally in 2 divided doses, with a maximum dose of 160 mg twice a day.
|
Short Course Treatment
n=314 Participants
5 days of placebo treatment to match physician-initiated therapy
Placebo: Placebo to match the other four active treatments
|
|---|---|---|
|
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 Participants
|
33 Participants
|
SECONDARY outcome
Timeframe: Up to Day 14Population: Intent-to-treat (ITT) Population: All subjects taking at least one dose of study treatment between Day 6 and Day 10 who have been evaluated for treatment success at TOC or have failed prior to TOC.
Outcome measures
| Measure |
Standard Course Treatment
n=328 Participants
5 days of active therapy to match the physician-initiated therapy, Trimethoprim sulfamethoxazole, Cefixime or Cefdinir or Cephalexin (subjects originally receiving Cefdinir will receive Cefixime)
Cefixime: Cefixime 8 mg/kg/day orally, in 1 dose, with a maximum of 400 mg. Subjects originally receiving Cefdinir will receive Cefixime.
Cephalexin: Cephalexin 50mg/kg/day in 3 divided doses
Trimethoprim/Sulfamethoxazole: 8 mg/kg/day of Trimethoprim-sulfamethoxazole (TMP-SMX) orally in 2 divided doses, with a maximum dose of 160 mg twice a day.
|
Short Course Treatment
n=336 Participants
5 days of placebo treatment to match physician-initiated therapy
Placebo: Placebo to match the other four active treatments
|
|---|---|---|
|
Comparison of the Number of Subjects With Positive Urine Cultures Following Short-course Versus Standard-course of Antibiotics.
|
6 Participants
|
41 Participants
|
SECONDARY outcome
Timeframe: Up to Day 14Population: Per-protocol Population (PP): The enrolled subjects who were adherent to their assigned study regimen and completed more than 80% of the prescribed dose between Day 6 and Day 10 (per-protocol population).
Outcome measures
| Measure |
Standard Course Treatment
n=308 Participants
5 days of active therapy to match the physician-initiated therapy, Trimethoprim sulfamethoxazole, Cefixime or Cefdinir or Cephalexin (subjects originally receiving Cefdinir will receive Cefixime)
Cefixime: Cefixime 8 mg/kg/day orally, in 1 dose, with a maximum of 400 mg. Subjects originally receiving Cefdinir will receive Cefixime.
Cephalexin: Cephalexin 50mg/kg/day in 3 divided doses
Trimethoprim/Sulfamethoxazole: 8 mg/kg/day of Trimethoprim-sulfamethoxazole (TMP-SMX) orally in 2 divided doses, with a maximum dose of 160 mg twice a day.
|
Short Course Treatment
n=314 Participants
5 days of placebo treatment to match physician-initiated therapy
Placebo: Placebo to match the other four active treatments
|
|---|---|---|
|
Comparison of the Number of Subjects With Positive Urine Cultures Following Short-course Versus Standard-course of Antibiotics. Per-protocol Population.
|
6 Participants
|
35 Participants
|
Adverse Events
Standard Course Treatment
Short Course Treatment
Serious adverse events
| Measure |
Standard Course Treatment
n=328 participants at risk
5 days of active therapy to match the physician-initiated therapy, Trimethoprim sulfamethoxazole, Cefixime or Cefdinir or Cephalexin (subjects originally receiving Cefdinir will receive Cefixime)
Cefixime: Cefixime 8 mg/kg/day orally, in 1 dose, with a maximum of 400 mg. Subjects originally receiving Cefdinir will receive Cefixime.
Cephalexin: Cephalexin 50mg/kg/day in 3 divided doses
Trimethoprim/Sulfamethoxazole: 8 mg/kg/day of Trimethoprim-sulfamethoxazole (TMP-SMX) orally in 2 divided doses, with a maximum dose of 160 mg twice a day.
|
Short Course Treatment
n=336 participants at risk
5 days of placebo treatment to match physician-initiated therapy
Placebo: Placebo to match the other four active treatments
|
|---|---|---|
|
Injury, poisoning and procedural complications
HUMERUS FRACTURE
|
0.30%
1/328 • Number of events 1 • Day 6 to Day 44 Follow-up Phone Call
|
0.00%
0/336 • Day 6 to Day 44 Follow-up Phone Call
|
|
General disorders
PYREXIA
|
0.30%
1/328 • Number of events 1 • Day 6 to Day 44 Follow-up Phone Call
|
0.30%
1/336 • Number of events 1 • Day 6 to Day 44 Follow-up Phone Call
|
|
Infections and infestations
PYELONEPHRITIS
|
0.00%
0/328 • Day 6 to Day 44 Follow-up Phone Call
|
0.30%
1/336 • Number of events 1 • Day 6 to Day 44 Follow-up Phone Call
|
|
Respiratory, thoracic and mediastinal disorders
ASTHMA
|
0.00%
0/328 • Day 6 to Day 44 Follow-up Phone Call
|
0.30%
1/336 • Number of events 1 • Day 6 to Day 44 Follow-up Phone Call
|
|
Congenital, familial and genetic disorders
URETHRAL VALVES
|
0.00%
0/328 • Day 6 to Day 44 Follow-up Phone Call
|
0.30%
1/336 • Number of events 1 • Day 6 to Day 44 Follow-up Phone Call
|
Other adverse events
| Measure |
Standard Course Treatment
n=328 participants at risk
5 days of active therapy to match the physician-initiated therapy, Trimethoprim sulfamethoxazole, Cefixime or Cefdinir or Cephalexin (subjects originally receiving Cefdinir will receive Cefixime)
Cefixime: Cefixime 8 mg/kg/day orally, in 1 dose, with a maximum of 400 mg. Subjects originally receiving Cefdinir will receive Cefixime.
Cephalexin: Cephalexin 50mg/kg/day in 3 divided doses
Trimethoprim/Sulfamethoxazole: 8 mg/kg/day of Trimethoprim-sulfamethoxazole (TMP-SMX) orally in 2 divided doses, with a maximum dose of 160 mg twice a day.
|
Short Course Treatment
n=336 participants at risk
5 days of placebo treatment to match physician-initiated therapy
Placebo: Placebo to match the other four active treatments
|
|---|---|---|
|
Gastrointestinal disorders
DIARRHOEA
|
12.8%
42/328 • Day 6 to Day 44 Follow-up Phone Call
|
10.1%
34/336 • Day 6 to Day 44 Follow-up Phone Call
|
|
General disorders
PYREXIA
|
4.6%
15/328 • Day 6 to Day 44 Follow-up Phone Call
|
5.4%
18/336 • Day 6 to Day 44 Follow-up Phone Call
|
|
Respiratory, thoracic and mediastinal disorders
RHINORRHOEA
|
3.7%
12/328 • Day 6 to Day 44 Follow-up Phone Call
|
4.8%
16/336 • Day 6 to Day 44 Follow-up Phone Call
|
|
Gastrointestinal disorders
VOMITING
|
3.4%
11/328 • Day 6 to Day 44 Follow-up Phone Call
|
6.0%
20/336 • Day 6 to Day 44 Follow-up Phone Call
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
6.4%
21/328 • Day 6 to Day 44 Follow-up Phone Call
|
6.8%
23/336 • Day 6 to Day 44 Follow-up Phone Call
|
|
Skin and subcutaneous tissue disorders
DERMATITIS DIAPER
|
3.0%
10/328 • Day 6 to Day 44 Follow-up Phone Call
|
3.6%
12/336 • Day 6 to Day 44 Follow-up Phone Call
|
|
Skin and subcutaneous tissue disorders
RASH
|
3.4%
11/328 • Day 6 to Day 44 Follow-up Phone Call
|
3.6%
12/336 • Day 6 to Day 44 Follow-up Phone Call
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
3.0%
10/328 • Day 6 to Day 44 Follow-up Phone Call
|
3.0%
10/336 • Day 6 to Day 44 Follow-up Phone Call
|
|
Gastrointestinal disorders
CONSTIPATION
|
2.4%
8/328 • Day 6 to Day 44 Follow-up Phone Call
|
2.1%
7/336 • Day 6 to Day 44 Follow-up Phone Call
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
2.1%
7/328 • Day 6 to Day 44 Follow-up Phone Call
|
1.5%
5/336 • Day 6 to Day 44 Follow-up Phone Call
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY DISORDER
|
1.2%
4/328 • Day 6 to Day 44 Follow-up Phone Call
|
1.2%
4/336 • Day 6 to Day 44 Follow-up Phone Call
|
|
Respiratory, thoracic and mediastinal disorders
NASAL CONGESTION
|
0.30%
1/328 • Day 6 to Day 44 Follow-up Phone Call
|
1.2%
4/336 • Day 6 to Day 44 Follow-up Phone Call
|
|
Infections and infestations
VIRAL INFECTION
|
0.30%
1/328 • Day 6 to Day 44 Follow-up Phone Call
|
1.2%
4/336 • Day 6 to Day 44 Follow-up Phone Call
|
|
Infections and infestations
GASTROENERITIS
|
1.2%
4/328 • Day 6 to Day 44 Follow-up Phone Call
|
0.00%
0/336 • Day 6 to Day 44 Follow-up Phone Call
|
|
Infections and infestations
NASOPHARYNGITIS
|
0.61%
2/328 • Day 6 to Day 44 Follow-up Phone Call
|
1.5%
5/336 • Day 6 to Day 44 Follow-up Phone Call
|
|
Infections and infestations
OTITIS MEDIA ACUTE
|
1.5%
5/328 • Day 6 to Day 44 Follow-up Phone Call
|
0.89%
3/336 • Day 6 to Day 44 Follow-up Phone Call
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.91%
3/328 • Day 6 to Day 44 Follow-up Phone Call
|
1.5%
5/336 • Day 6 to Day 44 Follow-up Phone Call
|
|
Gastrointestinal disorders
TEETHING
|
0.30%
1/328 • Day 6 to Day 44 Follow-up Phone Call
|
1.2%
4/336 • Day 6 to Day 44 Follow-up Phone Call
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place