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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).
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 study's 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 1:1 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active treatment | Experimental | 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) |
|
| Placebo treatment | Placebo Comparator | 5 days of placebo treatment to match physician-initiated therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cefixime | Drug | Cefixime 8 mg/kg/day orally, in 1 dose, with a maximum of 400 mg. Subjects originally receiving Cefdinir will receive Cefixime. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of Efficacy Based on Symptomatic Urinary Tract Infection (UTI) Between Short-course and Standard-course of Antibiotics. | 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:
| Day 11 through Day 14 |
| Comparison of Efficacy Based on Symptomatic Urinary Tract Infection (UTI) Between Short-course and Standard-course of Antibiotics. 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:
| Day 11 through Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| 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. |
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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)
Additional symptoms for children > 2 years of age:
Additional symptoms for children > / = 2 months to 2 years of age:
Only children who have been prescribed one of the four antibiotics for which a placebo is available will be eligible to participate.
Parental or guardian permission (informed consent) and if appropriate, child assent (if > / = seven years of age).
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Pittsburgh of UPMC - General Academic Pediatric | Pittsburgh | Pennsylvania | 15213-3205 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37358858 | Derived | Zaoutis T, Shaikh N, Fisher BT, Coffin SE, Bhatnagar S, Downes KJ, Gerber JS, Shope TR, Martin JM, Muniz GB, Green M, Nagg JP, Myers SR, Mistry RD, O'Connor S, Faig W, Black S, Rowley E, Liston K, Hoberman A. Short-Course Therapy for Urinary Tract Infections in Children: The SCOUT Randomized Clinical Trial. JAMA Pediatr. 2023 Aug 1;177(8):782-789. doi: 10.1001/jamapediatrics.2023.1979. |
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Of the 717 enrolled, 23 did not meet the screening criteria and 1 withdrew consent prior to randomization. 693 subjects were randomized.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Short Course Treatment | 5 days of placebo treatment to match physician-initiated therapy Placebo: Placebo to match the other four active treatments |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Of the 677 treated patients, only 664 were able to be evaluated for the primary endpoint.
Subject noncompliant: 4 Consent withdrawn: 3 Admin/Inv decision: 2 AE concomitant infection: 2 Lost to follow-up: 1 Protocol violation/deviation: 1
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Comparison of Efficacy Based on Symptomatic Urinary Tract Infection (UTI) Between Short-course and Standard-course of Antibiotics. | 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:
| 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. | Posted | Count of Participants | Participants | Day 11 through Day 14 |
Day 6 to Day 44 Follow-up Phone Call
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| HUMERUS FRACTURE | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| DIARRHOEA | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Elizabeth Rowley | Westat | (919) 941-8325 | ElizabethRowley@westat.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 20, 2018 | Jun 25, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 25, 2020 | Jun 25, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D014552 | Urinary Tract Infections |
| D004927 | Escherichia coli Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D020682 | Cefixime |
| D002506 | Cephalexin |
| D015662 | Trimethoprim, Sulfamethoxazole Drug Combination |
| ID | Term |
|---|---|
| D002439 | Cefotaxime |
| D002505 | Cephacetrile |
| D002511 | Cephalosporins |
| D047090 | beta-Lactams |
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| Cephalexin | Drug | Cephalexin 50mg/kg/day in 3 divided doses |
|
| Placebo | Other | Placebo to match the other four active treatments |
|
| Trimethoprim/Sulfamethoxazole | Drug | 8 mg/kg/day of Trimethoprim-sulfamethoxazole (TMP-SMX) orally in 2 divided doses, with a maximum dose of 160 mg twice a day. |
|
| Day 11 through Day 44 |
| 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. | A child would have emergent antibiotic resistance if they:
| Day 11 through Day 30 |
| 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. | A child would have emergent antibiotic resistance if they:
| Day 11 through Day 30 |
| Comparison of the Number of Subjects With Asymptomatic Bacteriuria Following Short-course Versus Standard-course of Antibiotics. | Asymptomatic Bacteriuria is defined in any SCOUT subject by:
| Day 11 through Day 14 |
| Comparison of the Number of Subjects With Asymptomatic Bacteriuria Following Short-course Versus Standard-course of Antibiotics. Per-protocol Population. | Asymptomatic Bacteriuria is defined in any SCOUT subject by:
| Day 11 through Day 14 |
| 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 |
| 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 |
| Comparison of the Number of Subjects With Positive Urine Cultures Following Short-course Versus Standard-course of Antibiotics. | Up to Day 14 |
| Comparison of the Number of Subjects With Positive Urine Cultures Following Short-course Versus Standard-course of Antibiotics. Per-protocol Population. | Up to Day 14 |
| Lost to Follow-up |
|
| Protocol Violation |
|
| Physician Decision |
|
| Consent Withdrawn/Voluntary Withdrawal |
|
| Administrative Decision |
|
| Entry Failure/Screening Failure |
|
| BG001 | Short Course Treatment | 5 days of placebo treatment to match physician-initiated therapy Placebo: Placebo to match the other four active treatments |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Customized | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
|
|
|
|
| Primary | Comparison of Efficacy Based on Symptomatic Urinary Tract Infection (UTI) Between Short-course and Standard-course of Antibiotics. 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:
| 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). | Posted | Count of Participants | Participants | Day 11 through Day 14 |
|
|
|
|
| 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. | Subjects in the ITT population who did not experience a treatment failure. | Posted | Count of Participants | Participants | 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. | Subjects in the per-protocol population who did not experience a treatment failure. | Posted | Count of Participants | Participants | 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. | A child would have emergent antibiotic resistance if they:
| 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. | Posted | Count of Participants | Participants | Day 11 through Day 30 |
|
|
|
|
| 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. | A child would have emergent antibiotic resistance if they:
| 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. | Posted | Count of Participants | Participants | Day 11 through Day 30 |
|
|
|
|
| Secondary | Comparison of the Number of Subjects With Asymptomatic Bacteriuria Following Short-course Versus Standard-course of Antibiotics. | Asymptomatic Bacteriuria is defined in any SCOUT subject by:
| 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. | Posted | Count of Participants | Participants | Day 11 through Day 14 |
|
|
|
|
| Secondary | Comparison of the Number of Subjects With Asymptomatic Bacteriuria Following Short-course Versus Standard-course of Antibiotics. Per-protocol Population. | Asymptomatic Bacteriuria is defined in any SCOUT subject by:
| 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). | Posted | Count of Participants | Participants | Day 11 through 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. | 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. | Posted | Count of Participants | Participants | 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 | 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). | Posted | Count of Participants | Participants | Up to Day 14 |
|
|
|
|
| Secondary | Comparison of the Number of Subjects With Positive Urine Cultures Following Short-course Versus Standard-course of Antibiotics. | 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. | Posted | Count of Participants | Participants | Up to Day 14 |
|
|
|
|
| Secondary | Comparison of the Number of Subjects With Positive Urine Cultures Following Short-course Versus Standard-course of Antibiotics. Per-protocol Population. | 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). | Posted | Count of Participants | Participants | Up to Day 14 |
|
|
|
|
| 0 |
| 328 |
| 2 |
| 328 |
| 155 |
| 328 |
| EG001 | Short Course Treatment | 5 days of placebo treatment to match physician-initiated therapy Placebo: Placebo to match the other four active treatments | 0 | 336 | 4 | 336 | 147 | 336 |
| PYREXIA | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| PYELONEPHRITIS | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| ASTHMA | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| URETHRAL VALVES | Congenital, familial and genetic disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| PYREXIA | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| RHINORRHOEA | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| VOMITING | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| DERMATITIS DIAPER | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| RASH | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| CONSTIPATION | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| RESPIRATORY DISORDER | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| NASAL CONGESTION | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| VIRAL INFECTION | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| GASTROENERITIS | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| NASOPHARYNGITIS | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| OTITIS MEDIA ACUTE | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| TEETHING | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D004756 | Enterobacteriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007769 |
| Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D013420 | Sulfamethoxazole |
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D013424 | Sulfanilamides |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D014295 | Trimethoprim |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
| 0.4876 |
| Superiority |
| 0.9782 |
| Superiority |