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| ID | Type | Description | Link |
|---|---|---|---|
| DORIPED3002 | Other Identifier | Janssen Research & Development, LLC | |
| 2009-015953-18 | Other Identifier | Janssen Research & Development, LLC |
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Trial terminated early per business decision
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The purpose of this study is to evaluate the safety and tolerability of doripenem compared to cefepime in children hospitalized with complicated urinary tract infections.
This is a randomized (study assigned by chance), double-blind (neither physician nor patient knows the name of the assigned study drugs), double-dummy (all patients are given both a placebo [salt solution] and study drug in alternating periods of time during the study), active comparator-controlled (compare the 'test' treatment to standard-of-care therapy), multinational, multicenter study to establish the safety and tolerability of the antibiotic doripenem compared with the antibiotic cefepime administered by intravenous (iv) infusion (slow injection of drug solution into the vein over a period of time) in children ages 3 months to less than 18 years hospitalized with a complicated urinary tract infection (cUTI). The study includes 3 periods: a pretreatment (screening) period that will occur within 2 days prior to randomization (assignment of study drug); a treatment period of 10 to 14 days where the patients will receive study drug treatment, and a posttreatment period consisting of 2 study visits. The maximum duration of study drug therapy is 14 days. The total duration of the study is approximately 7 to 8 weeks for each patient. Safety and tolerability will be evaluated by examining the incidence, severity, and type of adverse events, changes in clinical laboratory tests, vital sign measurements, and findings from physical examinations that are recorded as adverse events during treatment and at each posttreatment visit. An independent monitoring committee (IDMC) will be established for this study to ensure that the safety of patients is not compromised. The IDMC will consist of individuals who are not associated with the conduct of the study, and will include but will not be limited to individuals with expertise relevant to the care of pediatric patients, and including at least one infectious disease physician and at least one statistician. IV study drug therapy (Cefepime [50mg/kg up to 2g/dose] and doripenem placebo or doripenem [20mg/kg up to 500mg/dose] and cefepime placebo will be administered once every 8 hours for up to 14 days. After receiving a minimum of 3 days of IV study drug therapy, patients may be discharged from the hospital and continue PO antibiotic therapy with amoxicillin/clavulanate potassium, ciprofloxacin, or alternative antibiotic therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Doripenem | Experimental | Doripenem 20 mg/kg per dose (up to 500 mg/dose) will be administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days. |
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| Cefepime | Experimental | Cefepime 50 mg/kg per dose (up to 2 g/dose) will be dministered every 8 hours as 30-minutes IV (at least 3 days of IV cefepime only or IV cefepime followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Doripenem | Drug | Type=once every 8 hours infused over 60 minutes, Unit=mg,Number=20mg/kg up to 500mg/dose, Form=solution for infusion,Route=intravenous use. At least 3 days of iv doripenem administered every 8 hours immediately after each iv infusion of cefepime placebo for up to 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Participants With Clinical Cure Rate at Test Of Cure (TOC) Visit | The participants were classified as cure if they had resolution or clinical improvement in signs and symptoms of complicated urinary tract infection; had no fever; no additional antimicrobial therapy was required for the treatment of the infection; and a clinical response assessment of improvement at End of IV visit. | TOC (7 to 14 days after the last dose of study medication therapy) |
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Participants With Clinical Improvement Rate at End of IV (EIV) Visit | The participants were considered as clinical improved if they had clinical improvement in signs and symptoms from baseline; no fever for at least the 24 hours before discontinuing the IV study drug; and not received nonstudy antibiotics for the treatment of urinary tract infection after IV study drug therapy had begun. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC C. Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Little Rock | Arkansas | United States | ||||
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Doripenem | Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days. |
| FG001 | Cefepime |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Doripenem placebo | Drug | Form=solution for infusion, Route=intravenous use, administered once every 8 hours infused over 60 minutes immediately following each iv infusion of cefepime for up to 14 days |
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| Cefepime | Drug | Type=once every 8 hours, Unit=mg, Number=50 mg/kg up to 2g/dose, Form=solution for infusion, Route=intravenous use. At least 3 days of iv cefepime administered every 8 hours infused over 30 minutes immediately before each iv infusion of doripenem placebo for up to 14 days |
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| Cefepime placebo | Drug | Form=solution for infusion, Route=intravenous use, administered once every 8 hours infused over 30 minutes immediately before each iv infusion of doripenem for up to 14 days |
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| Amoxicillin/clavulanate potassium | Drug | Form=suspension or tablets, Route=oral (by mouth), may be administered at the discretion of the investigator once every 12 hours for up to 14 days following IV therapy with doripenem or cefepime. |
|
| EIV (within 24 hours after completion of the last dose of IV study medication therapy) |
| The Number of Participants With Clinical Cure Rate at Late Follow-Up (LFU) Visit | The participants were classified as clinical cure if all pretreatment signs and symptoms of complicated urinary tract infection showed no evidence of recurrence after test of cure. | LFU (28 to 42 days after the last dose of study medication therapy) |
| The Number of Participants With Favorable Per-participant Microbiological Response | Favorable per-participant microbiological response rate was evaluated at the at End of IV (EIV) visit, Test Of Cure (TOC) visit, and Late Follow-Up (LFU) visit. The favorable per-participant microbiological response was considered when all baseline pathogens were eradicated (absence) or presumed eradicated (absence of material to culture in a participant who has a positive clinical response to treatment). | EIV (within 24 hours after completion of the last dose of IV study medication therapy), TOC (7 to 14 days after the last dose of study medication therapy), and LFU (28 to 42 days after the last dose of study medication therapy) |
| Number of Participants With Favorable Per-pathogen Microbiological Outcome Rate at End of IV (EIV) Visit | The favorable per-pathogen microbiological outcome was considered when all baseline pathogens were eradicated (absence) or presumed eradicated (absence of material to culture in a participant who has a positive clinical response to treatment).A total of 4 pathogens in the doripenem group and 2 pathogens in the cefepime group were isolated at baseline from urine culture and were susceptible to the study drug received (see listed in the table below; the numbers in parenthesis next to each pathogen represent the number of participants with the pathogen isolated at baseline in the doripenem and cefepime treatment groups, respectively). | EIV (within 24 hours after completion of the last dose of IV study medication therapy) |
| Number of Participants With Favorable Per-pathogen Microbiological Outcome Rate at Test Of Cure (TOC) Visit | The favorable per-pathogen microbiological outcome was considered when all baseline pathogens were eradicated (absence) or presumed eradicated (absence of material to culture in a participant who has a positive clinical response to treatment). A total of 4 pathogens in the doripenem group and 2 pathogens in the cefepime group were isolated at baseline from urine culture and were susceptible to the study drug received (see listed in the table below; the numbers in parenthesis next to each pathogen represent the number of participants with the pathogen isolated at baseline in the doripenem and cefepime treatment groups, respectively). | TOC (7 to 14 days after the last dose of study medication therapy) |
| Number of Participants With Sustained Favorable Per-pathogen Microbiological Outcome Rate at Late Follow-Up (LFU) Visit | The sustained favorable per-pathogen microbiological outcome was considered when all baseline pathogens were eradicated (absence) or presumed eradicated (absence of material to culture in a participant who has a positive clinical response to treatment). A total of 4 pathogens in the doripenem group and 2 pathogens in the cefepime group were isolated at baseline from urine culture and were susceptible to the study drug received (see listed in the table below; the numbers in parenthesis next to each pathogen represent the number of participants with the pathogen isolated at baseline in the doripenem and cefepime treatment groups, respectively). | LFU (28 to 42 days after the last dose of study medication therapy) |
| Oakland |
| California |
| United States |
| Orange | California | United States |
| San Diego | California | United States |
| Washington D.C. | District of Columbia | United States |
| New Brunswick | New Jersey | United States |
| Albany | New York | United States |
| The Bronx | New York | United States |
| Cleveland | Ohio | United States |
| Toledo | Ohio | United States |
| Pittsburgh | Pennsylvania | United States |
| Buenos Aires | Argentina |
| Córdoba | Argentina |
| Loma Hermosa | Argentina |
| Santa Fe | Argentina |
| Belo Horizonte | Brazil |
| Caxias do Sul | Brazil |
| Passo Fundo | Brazil |
| São Paulo | Brazil |
| Santiago | Chile |
| Valdivia X Región | Chile |
| Bogotá | Colombia |
| Cali | Colombia |
| Floridablanca | Colombia |
| MedellÃn | Colombia |
| Hradec Králové | Czechia |
| Prague | Czechia |
| Riga | Latvia |
| Kaunas | Lithuania |
| Vilnius | Lithuania |
| Guadajalara | Mexico |
| Monterrey | Mexico |
| Zapopan | Mexico |
| Zona | Panama |
| Lublin | Poland |
| Szczecin | Poland |
| Kharkiv | Ukraine |
| Poltava | Ukraine |
Cefepime 50 mg/kg per dose (up to 2 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV cefepime only or IV cefepime followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Doripenem | Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days. |
| BG001 | Cefepime | Cefepime 50 mg/kg per dose (up to 2 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV cefepime only or IV cefepime followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Age, Customized | Number | participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 | The Number of Participants With Clinical Cure Rate at Test Of Cure (TOC) Visit | The participants were classified as cure if they had resolution or clinical improvement in signs and symptoms of complicated urinary tract infection; had no fever; no additional antimicrobial therapy was required for the treatment of the infection; and a clinical response assessment of improvement at End of IV visit. | Clinical Intent-to-Treat (CITT): All randomized participants who met the minimal disease definition of complicated urinary tract infection regardless if a baseline pathogen was isolated from the pretreatment urine culture. | Posted | Number | Participants | TOC (7 to 14 days after the last dose of study medication therapy) |
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| Secondary | The Number of Participants With Clinical Improvement Rate at End of IV (EIV) Visit | The participants were considered as clinical improved if they had clinical improvement in signs and symptoms from baseline; no fever for at least the 24 hours before discontinuing the IV study drug; and not received nonstudy antibiotics for the treatment of urinary tract infection after IV study drug therapy had begun. | Clinical Intent-to-Treat (CITT): All randomized participants who met the minimal disease definition of complicated urinary tract infection regardless if a baseline pathogen was isolated from the pretreatment urine culture. | Posted | Number | Participants | EIV (within 24 hours after completion of the last dose of IV study medication therapy) |
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| Secondary | The Number of Participants With Clinical Cure Rate at Late Follow-Up (LFU) Visit | The participants were classified as clinical cure if all pretreatment signs and symptoms of complicated urinary tract infection showed no evidence of recurrence after test of cure. | Clinical Intent-to-Treat (CITT): All randomized participants who met the minimal disease definition of complicated urinary tract infection regardless if a baseline pathogen was isolated from the pretreatment urine culture. | Posted | Number | Participants | LFU (28 to 42 days after the last dose of study medication therapy) |
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| ||||||||||||||||||||||||||||||
| Secondary | The Number of Participants With Favorable Per-participant Microbiological Response | Favorable per-participant microbiological response rate was evaluated at the at End of IV (EIV) visit, Test Of Cure (TOC) visit, and Late Follow-Up (LFU) visit. The favorable per-participant microbiological response was considered when all baseline pathogens were eradicated (absence) or presumed eradicated (absence of material to culture in a participant who has a positive clinical response to treatment). | Microbiological intent-to-treat - Participants of all CITT with at least 1 baseline bacterial pathogen isolated from the pretreatment urine culture, susceptible to both doripenem and cefepime. 6 and 2 participants from doripenem and cefepime, respectively had no susceptible urine pathogens at baseline and were excluded from this set. | Posted | Number | Participants | EIV (within 24 hours after completion of the last dose of IV study medication therapy), TOC (7 to 14 days after the last dose of study medication therapy), and LFU (28 to 42 days after the last dose of study medication therapy) |
| |||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Favorable Per-pathogen Microbiological Outcome Rate at End of IV (EIV) Visit | The favorable per-pathogen microbiological outcome was considered when all baseline pathogens were eradicated (absence) or presumed eradicated (absence of material to culture in a participant who has a positive clinical response to treatment).A total of 4 pathogens in the doripenem group and 2 pathogens in the cefepime group were isolated at baseline from urine culture and were susceptible to the study drug received (see listed in the table below; the numbers in parenthesis next to each pathogen represent the number of participants with the pathogen isolated at baseline in the doripenem and cefepime treatment groups, respectively). | Microbiological intent-to-treat - Participants of all CITT with at least 1 baseline bacterial pathogen isolated from the pretreatment urine culture, susceptible to both doripenem and cefepime. 6 and 2 participants from doripenem and cefepime, respectively had no susceptible urine pathogens at baseline and were excluded from this set. | Posted | Number | Participants | EIV (within 24 hours after completion of the last dose of IV study medication therapy) |
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| Secondary | Number of Participants With Favorable Per-pathogen Microbiological Outcome Rate at Test Of Cure (TOC) Visit | The favorable per-pathogen microbiological outcome was considered when all baseline pathogens were eradicated (absence) or presumed eradicated (absence of material to culture in a participant who has a positive clinical response to treatment). A total of 4 pathogens in the doripenem group and 2 pathogens in the cefepime group were isolated at baseline from urine culture and were susceptible to the study drug received (see listed in the table below; the numbers in parenthesis next to each pathogen represent the number of participants with the pathogen isolated at baseline in the doripenem and cefepime treatment groups, respectively). | Microbiological intent-to-treat - Participants of all CITT with at least 1 baseline bacterial pathogen isolated from the pretreatment urine culture, susceptible to both doripenem and cefepime. 6 and 2 participants from doripenem and cefepime, respectively had no susceptible urine pathogens at baseline and were excluded from this set. | Posted | Number | Participants | TOC (7 to 14 days after the last dose of study medication therapy) |
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| Secondary | Number of Participants With Sustained Favorable Per-pathogen Microbiological Outcome Rate at Late Follow-Up (LFU) Visit | The sustained favorable per-pathogen microbiological outcome was considered when all baseline pathogens were eradicated (absence) or presumed eradicated (absence of material to culture in a participant who has a positive clinical response to treatment). A total of 4 pathogens in the doripenem group and 2 pathogens in the cefepime group were isolated at baseline from urine culture and were susceptible to the study drug received (see listed in the table below; the numbers in parenthesis next to each pathogen represent the number of participants with the pathogen isolated at baseline in the doripenem and cefepime treatment groups, respectively). | Microbiological intent-to-treat - Participants of all CITT with at least 1 baseline bacterial pathogen isolated from the pretreatment urine culture, susceptible to both doripenem and cefepime. 6 and 2 participants from doripenem and cefepime, respectively had no susceptible urine pathogens at baseline and were excluded from this set. | Posted | Number | Participants | LFU (28 to 42 days after the last dose of study medication therapy) |
|
Approximately 8 weeks
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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 | Doripenem | Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days. | 1 | 30 | 11 | 30 | ||
| EG001 | Cefepime | Cefepime 50 mg/kg per dose (up to 2 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV cefepime only or IV cefepime followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days. | 3 | 10 | 6 | 10 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pyuria | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
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| Pseudomembranous Colitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
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| Pyelonephritis Acute | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
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| Urinary Tract Infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 16.0 | Systematic Assessment |
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| Infusion Site Pain | General disorders | MedDRA 16.0 | Systematic Assessment |
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| Vessel Puncture Site Pain | General disorders | MedDRA 16.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
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| Bacteriuria | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Candidiasis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
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| Pharyngitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Productive Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
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| Eosinophilia | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
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| Hypochromic Anaemia | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
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| Neutrophilia | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
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| Papule | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
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| Skin Haemorrhage | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
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| Congenital Thrombocyte Disorder | Congenital, familial and genetic disorders | MedDRA 16.0 | Systematic Assessment |
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| Overdose | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
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| Basophil Count Increased | Investigations | MedDRA 16.0 | Systematic Assessment |
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| Urine Leukocyte Esterase | Investigations | MedDRA 16.0 | Systematic Assessment |
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| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
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| Crystalluria | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
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| Haematuria | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
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| Leukocyturia | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
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| Proteinuria | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
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| Phlebitis | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
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This study was terminated early due to business reasons and not related to safety concerns or issues. As such, the limited enrollment precludes a meaningful conclusion about the efficacy and safety of doripenem compared with cefepime.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Areas Director | Janssen R&D US | ClinicalTrialDisclosure@its.jnj.com |
| ID | Term |
|---|---|
| D011704 | Pyelonephritis |
| ID | Term |
|---|---|
| D009395 | Nephritis, Interstitial |
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D011702 | Pyelitis |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D000077726 | Doripenem |
| D000077723 | Cefepime |
| D019980 | Amoxicillin-Potassium Clavulanate Combination |
| ID | Term |
|---|---|
| D015780 | Carbapenems |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D002511 | Cephalosporins |
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D019818 | Clavulanic Acid |
| D002969 | Clavulanic Acids |
| D000658 | Amoxicillin |
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
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| >=65 years |
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| 2 to <6 years |
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| 6 to <12 years |
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| 12 to <18 years |
|
| Male |
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| Units | Counts |
|---|---|
| Participants |
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| Participants |
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Cefepime 50 mg/kg per dose (up to 2 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV cefepime only or IV cefepime followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days. |
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Cefepime 50 mg/kg per dose (up to 2 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV cefepime only or IV cefepime followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
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Cefepime 50 mg/kg per dose (up to 2 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV cefepime only or IV cefepime followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days. |
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