Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2026-02-21 @ 6:45 PM
Study NCT ID:
NCT01400867
Status:
COMPLETED
Last Update Posted:
2015-01-13
First Post:
2011-07-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy Study of Ceftaroline Versus a Comparator in Pediatric Subjects With Complicated Skin Infections
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000097583', 'term': 'Ceftaroline'}, {'id': 'D002506', 'term': 'Cephalexin'}, {'id': 'D002981', 'term': 'Clindamycin'}, {'id': 'D000069349', 'term': 'Linezolid'}], 'ancestors': [{'id': 'D002511', 'term': 'Cephalosporins'}, {'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013843', 'term': 'Thiazines'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D008034', 'term': 'Lincomycin'}, {'id': 'D055231', 'term': 'Lincosamides'}, {'id': 'D011759', 'term': 'Pyrrolidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D000081', 'term': 'Acetamides'}, {'id': 'D000085', 'term': 'Acetates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D023303', 'term': 'Oxazolidinones'}, {'id': 'D010080', 'term': 'Oxazoles'}, {'id': 'D001393', 'term': 'Azoles'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 163}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-01-12', 'studyFirstSubmitDate': '2011-07-19', 'studyFirstSubmitQcDate': '2011-07-21', 'lastUpdatePostDateStruct': {'date': '2015-01-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-07-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate the safety and tolerability of ceftaroline versus comparator in pediatric subjects ages 2 months to < 18 years with ABSSSI.', 'timeFrame': 'Between 26 and 50 days.', 'description': 'Evaluate the safety and tolerability of IV administered ceftaroline fosamil in children with skin infections. Summaries of AEs, SAEs, deaths, laboratory evaluations (hematology studies, comprehensive and metabolic panel), pain scales, vital signs, and physical examinations will be provided for each treatment group.'}], 'secondaryOutcomes': [{'measure': 'Evaluate the efficacy of ceftaroline versus comparator in pediatric subjects ages 2 months to < 18 years with ABSSSI.', 'timeFrame': 'Between 1 and 5 days', 'description': 'The number and percentage of subjects in each treatment group classified as clinical cure in the Modified Intent to Treat (MITT) and Clinical Evaluable (CE) populations at Day 3, EOIV, EOT and TOC.'}, {'measure': 'Evaluate the pharmacokinetics of ceftaroline versus comparator in pediatric subjects ages 2 months to < 18 years with ABSSSI.', 'timeFrame': 'Between 1 and 5 days', 'description': 'Analyze concentrations of ceftaroline fosamil, ceftaroline, and M-1 in plasma, and if available, in cerebrospinal fluid (CSF; if collected as part of routine medical care)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Infections', 'Pediatrics', 'Teflaro', 'cephalosporin'], 'conditions': ['Infections, Pediatrics']}, 'descriptionModule': {'briefSummary': 'This is a study of safety, effectiveness, blood levels and tolerance of Ceftaroline fosamil in children with skin infections receiving antibiotic therapy in the hospital.', 'detailedDescription': 'To evaluate safety, effectiveness, pharmacokinetics and tolerance of Ceftaroline fosamil in children who are initially hospitalized with Acute Bacterial Skin and Skin Structure Infections (ABSSSI).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '2 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female, 2 months to \\< 18 years old.\n* Presence of ABSSSI warranting initial hospitalization.\n* Presence of ABSSSI with measurable margins of erythema, that includes deeper and/or extensive soft tissue involvement, or requires significant therapeutic surgical intervention\n\nExclusion Criteria:\n\n* Documented history of any hypersensitivity or allergic reaction to vancomycin, aztreonam, or any β-lactam antimicrobial\n* Uncomplicated skin and soft tissue infections\n* More than 24 hours of prior antimicrobial therapy ≤ 96 hours before randomization.\n* Requirement for any concomitant systemic antimicrobial therapy\n* History of seizures, excluding well-documented febrile seizure of childhood.\n* Clinical signs or suspicion of meningitis'}, 'identificationModule': {'nctId': 'NCT01400867', 'briefTitle': 'Safety and Efficacy Study of Ceftaroline Versus a Comparator in Pediatric Subjects With Complicated Skin Infections', 'organization': {'class': 'INDUSTRY', 'fullName': 'Forest Laboratories'}, 'officialTitle': 'A Multicenter, Randomized, Observer-Blinded, Active-Controlled Study to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetics of Ceftaroline Versus Comparator in Pediatric Subjects With Acute Bacterial Skin and Skin Structure Infections', 'orgStudyIdInfo': {'id': 'P903-23'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ceftaroline fosamil', 'interventionNames': ['Drug: Ceftaroline fosamil', 'Drug: Cephalexin or Clindamycin or Linezolid']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Comparators', 'description': 'Vancomycin +/- Aztreonam Cefazolin +/- Aztreonam', 'interventionNames': ['Drug: Vancomycin +/- Aztreonam or Cefazolin +/- Aztreonam', 'Drug: Cephalexin or Clindamycin or Linezolid']}], 'interventions': [{'name': 'Ceftaroline fosamil', 'type': 'DRUG', 'otherNames': ['Teflaro', 'PPI-0903', 'TAK-599', 'TAK599', 'PPI0903'], 'description': 'Subjects ≥ 6 months old: 12 mg/kg IV for subjects weighing ≤ 33 kg and 400 mg for subjects weighing \\> 33 kg will be infused over 60 (± 10) minutes every 8 hours (q8h) (± 1 hour)\n\nSubjects \\< 6 months old: 8mg/kg infused over 60 (± 10) minutes every 8 hours (q8h) (± 1 hour)', 'armGroupLabels': ['Ceftaroline fosamil']}, {'name': 'Vancomycin +/- Aztreonam or Cefazolin +/- Aztreonam', 'type': 'DRUG', 'description': 'Vancomycin 15mg/kg IV over 60 minutes (or a maximum of 10mg/min whichever is longer) +/- Aztreonam 30 mg/kg IV every 8 hours over 60 minutes (for infections involving gram negative pathogen suspected or confirmed)\n\nCefazolin 75mg/kg IV divided every 8 hours over 60 minutes (for sites that do not empirically cover for MRSA) +/- Aztreonam 30 mg/kg IV every 8 hours over 60 minutes (for infections involving gram negative pathogen suspected or confirmed', 'armGroupLabels': ['Comparators']}, {'name': 'Cephalexin or Clindamycin or Linezolid', 'type': 'DRUG', 'description': 'Possible oral switch on or after study day 4.\n\nCephalexin: 25 mg/kg q6h PO or Clindamycin: 10 mg/kg q8h PO or Linezolid 600mg q12h (cohort 1) or 10 mg/kg q8h (cohorts 2,3 and 4) PO.', 'armGroupLabels': ['Ceftaroline fosamil', 'Comparators']}]}, 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