Trial · NCT01595529
The SCOUT Study: "Short Course Therapy for Urinary Tract Infections in Children"
NCT01595529, Phase 2, Completed, National Institute of Allergy and Infectious Diseases (NIAID); results first posted 2020-07-13
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ConductScience Library. The SCOUT Study: "Short Course Therapy for Urinary Tract Infections in Children". Trials, record NCT01595529. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01595529
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The SCOUT Study: "Short Course Therapy for Urinary Tract Infections in Children"
- NCT number
- NCT01595529
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 717 participants, actual
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Conditions
- Urinary Tract Infection
- Interventions
- Cefixime, Cephalexin, Placebo, Trimethoprim/Sulfamethoxazole
- First posted
- 2012-05-10
- Last updated
- 2020-08-06
- Results first posted
- 2020-07-13
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Comparison of Efficacy Based on Symptomatic Urinary Tract Infection (UTI) Between Short-course and Standard-course of Antibiotics. | Day 11 through Day 14 | 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. |
| Primary | Comparison of Efficacy Based on Symptomatic Urinary Tract Infection (UTI) Between Short-course and Standard-course of Antibiotics. Per-protocol Population. | Day 11 through Day 14 | 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. |
| 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. | Day 11 through Day 44 | |
| 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. | Day 11 through Day 44 | |
| 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. | Day 11 through Day 30 | 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. |
| 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. | Day 11 through Day 30 | 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. |
| Secondary | Comparison of the Number of Subjects With Asymptomatic Bacteriuria Following Short-course Versus Standard-course of Antibiotics. | Day 11 through Day 14 | 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). |
| Secondary | Comparison of the Number of Subjects With Asymptomatic Bacteriuria Following Short-course Versus Standard-course of Antibiotics. Per-protocol Population. | Day 11 through Day 14 | 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). |
| 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. | Up to Day 14 | |
| 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 | Up to Day 14 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Comparison of Efficacy Based on Symptomatic Urinary Tract Infection (UTI) Between Short-course and Standard-course of Antibiotics. | Day 11 through Day 14 | 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. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Comparison of Efficacy Based on Symptomatic Urinary Tract Infection (UTI) Between Short-course and Standard-course of Antibiotics. Per-protocol Population. | Day 11 through Day 14 | 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). | Participants | COUNT_OF_PARTICIPANTS |
| 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. | Day 11 through Day 44 | Subjects in the ITT population who did not experience a treatment failure. | Participants | COUNT_OF_PARTICIPANTS |
| 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. | Day 11 through Day 44 | Subjects in the per-protocol population who did not experience a treatment failure. | Participants | COUNT_OF_PARTICIPANTS |
| 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. | Day 11 through Day 30 | 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. | Participants | COUNT_OF_PARTICIPANTS |
| 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. | Day 11 through Day 30 | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Comparison of the Number of Subjects With Asymptomatic Bacteriuria Following Short-course Versus Standard-course of Antibiotics. | Day 11 through Day 14 | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Comparison of the Number of Subjects With Asymptomatic Bacteriuria Following Short-course Versus Standard-course of Antibiotics. Per-protocol Population. | Day 11 through Day 14 | 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). | Participants | COUNT_OF_PARTICIPANTS |
| 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. | Up to Day 14 | 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. | Participants | COUNT_OF_PARTICIPANTS |
| 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 | Up to Day 14 | 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). | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group28
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Comparison of Efficacy Based on Symptomatic Urinary Tract Infection (UTI) Between Short-course and Standard-course of Antibiotics. | Standard Course Treatment | 2 | Participants | ||
| Comparison of Efficacy Based on Symptomatic Urinary Tract Infection (UTI) Between Short-course and Standard-course of Antibiotics. | Short Course Treatment | 14 | Participants | ||
| Comparison of Efficacy Based on Symptomatic Urinary Tract Infection (UTI) Between Short-course and Standard-course of Antibiotics. Per-protocol Population. | Standard Course Treatment | 2 | Participants | ||
| Comparison of Efficacy Based on Symptomatic Urinary Tract Infection (UTI) Between Short-course and Standard-course of Antibiotics. Per-protocol Population. | Short Course Treatment | 9 | Participants | ||
| 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. | Standard Course Treatment | 12 | Participants | ||
| 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. | Short Course Treatment | 13 | Participants | ||
| 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. | Standard Course Treatment | 10 | Participants | ||
| 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. | Short Course Treatment | 13 | 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. | Standard Course Treatment | Test of Cure Visit (Day 11-14) | 22 | 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. | Short Course Treatment | Test of Cure Visit (Day 11-14) | 31 | Participants |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow22
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Standard Course Treatment | 348 | |
| Overall Study | STARTED | Short Course Treatment | 345 | |
| Overall Study | Treated | Standard Course Treatment | 337 | |
| Overall Study | Treated | Short Course Treatment | 340 | |
| Overall Study | Evaluated for Primary Endpoint, ITT | Standard Course Treatment | 328 | |
| Overall Study | Evaluated for Primary Endpoint, ITT | Short Course Treatment | 336 | |
| Overall Study | ITT Without Treatment Failure | Standard Course Treatment | 326 | |
| Overall Study | ITT Without Treatment Failure | Short Course Treatment | 322 | |
| Overall Study | ITT With Stool Sample at TOC | Standard Course Treatment | 298 | |
| Overall Study | ITT With Stool Sample at TOC | Short Course Treatment | 310 |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 participant flowAdverse events46
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | DIARRHOEA | Gastrointestinal disorders | Standard Course Treatment | 42 | 328 | |
| other | DIARRHOEA | Gastrointestinal disorders | Short Course Treatment | 34 | 336 | |
| other | PYREXIA | General disorders | Standard Course Treatment | 15 | 328 | |
| other | PYREXIA | General disorders | Short Course Treatment | 18 | 336 | |
| other | RHINORRHOEA | Respiratory, thoracic and mediastinal disorders | Standard Course Treatment | 12 | 328 | |
| other | RHINORRHOEA | Respiratory, thoracic and mediastinal disorders | Short Course Treatment | 16 | 336 | |
| other | VOMITING | Gastrointestinal disorders | Standard Course Treatment | 11 | 328 | |
| other | VOMITING | Gastrointestinal disorders | Short Course Treatment | 20 | 336 | |
| other | COUGH | Respiratory, thoracic and mediastinal disorders | Standard Course Treatment | 21 | 328 | |
| other | COUGH | Respiratory, thoracic and mediastinal disorders | Short Course Treatment | 23 | 336 |
1 to 10 of 46Source ClinicalTrials.gov
See all 46 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Standard Course Treatment | 0 | 328 |
| Total, all-cause mortality | Short Course Treatment | 0 | 336 |
| Total, other adverse events | Standard Course Treatment | 155 | 328 |
| Total, other adverse events | Short Course Treatment | 147 | 336 |
| Total, serious adverse events | Standard Course Treatment | 2 | 328 |
| Total, serious adverse events | Short Course Treatment | 4 | 336 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37358858 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons12
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
Standard Course Treatment vs Short Course Treatment: 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. | Trial comparisons |
Standard Course Treatment vs Short Course Treatment: Comparison of Efficacy Based on Symptomatic Urinary Tract Infection (UTI) Between Short-course and Standard-course of Antibiotics. Per-protocol Population. | Trial comparisons |
| Standard Course Treatment vs Short Course Treatment: Comparison of the Number of Subjects With Asymptomatic Bacteriuria Following Short-course Versus Standard-course of Antibiotics. | Trial comparisons |
Standard Course Treatment vs Short Course Treatment: 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. | Trial comparisons |
Standard Course Treatment vs Short Course Treatment: Comparison of the Number of Subjects With Clinical Symptoms That May be Related to a UTI Following Short-course Versus Standard-course of Antibiotics. | Trial comparisons |
Standard Course Treatment vs Short Course Treatment: Comparison of the Number of Subjects With Positive Urine Cultures Following Short-course Versus Standard-course of Antibiotics. Per-protocol Population. | Trial comparisons |
Standard Course Treatment vs Short Course Treatment: 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 | Trial comparisons |
Standard Course Treatment vs Short Course Treatment: Comparison of the Number of Subjects With Asymptomatic Bacteriuria Following Short-course Versus Standard-course of Antibiotics. Per-protocol Population. | Trial comparisons |
| Standard Course Treatment vs Short Course Treatment: Comparison of Efficacy Based on Symptomatic Urinary Tract Infection (UTI) Between Short-course and Standard-course of Antibiotics. | Trial comparisons |
| Standard Course Treatment vs Short Course Treatment: deaths from any cause | Trial comparisons |
1 to 10 of 12
See all 12 trial comparisonsTests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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