Safety and Efficacy Study of Ceftaroline Versus a Comparator in Pediatric Subjects With Complicated Skin Infections
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Infections, Pediatrics |
Drug: Ceftaroline fosamil Drug: Vancomycin +/- Aztreonam or Cefazolin +/- Aztreonam Drug: Cephalexin or Clindamycin or Linezolid |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment |
| Official Title: | 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 |
- Evaluate the safety and tolerability of ceftaroline versus comparator in pediatric subjects ages 2 months to < 18 years with ABSSSI. [ Time Frame: Between 26 and 50 days. ] [ Designated as safety issue: Yes ]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.
- Evaluate the efficacy of ceftaroline versus comparator in pediatric subjects ages 2 months to < 18 years with ABSSSI. [ Time Frame: Between 1 and 5 days ] [ Designated as safety issue: No ]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.
- Evaluate the pharmacokinetics of ceftaroline versus comparator in pediatric subjects ages 2 months to < 18 years with ABSSSI. [ Time Frame: Between 1 and 5 days ] [ Designated as safety issue: No ]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)
| Estimated Enrollment: | 270 |
| Study Start Date: | December 2011 |
| Estimated Study Completion Date: | November 2014 |
| Estimated Primary Completion Date: | May 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Ceftaroline fosamil |
Drug: Ceftaroline fosamil
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) Subjects < 6 months old: 8mg/kg infused over 60 (± 10) minutes every 8 hours (q8h) (± 1 hour) Other Names:
Drug: Cephalexin or Clindamycin or Linezolid
Possible oral switch on or after study day 4. Cephalexin: 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. |
|
Active Comparator: Comparators
Vancomycin +/- Aztreonam Cefazolin +/- Aztreonam
|
Drug: Vancomycin +/- Aztreonam or Cefazolin +/- Aztreonam
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) Cefazolin 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 Possible oral switch on or after study day 4. Cephalexin: 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. |
Detailed Description:
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).
Eligibility| Ages Eligible for Study: | 2 Months to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Male or female, 2 months to < 18 years old.
- Presence of ABSSSI warranting initial hospitalization.
- Presence of ABSSSI with measurable margins of erythema, that includes deeper and/or extensive soft tissue involvement, or requires significant therapeutic surgical intervention
Exclusion Criteria:
- Documented history of any hypersensitivity or allergic reaction to vancomycin, aztreonam, or any β-lactam antimicrobial
- Uncomplicated skin and soft tissue infections
- More than 24 hours of prior antimicrobial therapy ≤ 96 hours before randomization.
- Requirement for any concomitant systemic antimicrobial therapy
- History of seizures, excluding well-documented febrile seizure of childhood.
- Clinical signs or suspicion of meningitis
Contacts and Locations| Contact: Cerexa Trial Coordinator | 510-285-9200 | clinicaltrials@cerexa.com |
Show 46 Study Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Cerexa, Inc. |
| ClinicalTrials.gov Identifier: | NCT01400867 History of Changes |
| Other Study ID Numbers: | P903-23 |
| Study First Received: | July 19, 2011 |
| Last Updated: | March 29, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Cerexa, Inc.:
|
Infections Pediatrics Teflaro cephalosporin |
Additional relevant MeSH terms:
|
Aztreonam Cefazolin Cephalexin Clindamycin Clindamycin-2-phosphate Vancomycin Linezolid |
Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Protein Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 16, 2013