Safety and Efficacy Study of Ceftaroline Versus a Comparator in Pediatric Subjects With Complicated Skin Infections

Phase 2

Completed

• Conditions: Infections, Pediatrics
• Interventions: Drug: Vancomycin +/- Aztreonam or Cefazolin +/- Aztreonam; Drug: Ceftaroline fosamil; Drug: Cephalexin or Clindamycin or Linezolid

• Registration Number: NCT01400867
• Lead Sponsor: Forest Laboratories

Brief Summary

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.

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).

Study Timeline

• Study First Submitted: 2011-07-19
• Study First Submitted QC: 2011-07-21
• Study First Posted: 2011-07-22
• Study Start: 2011-12
• Primary Completion: 2014-05
• Study Completion: 2014-07
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-12
• Last Update Posted: 2015-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 163

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ceftaroline fosamil	Cephalexin or Clindamycin or Linezolid	-
Comparators	Cephalexin or Clindamycin or Linezolid	Vancomycin +/- Aztreonam Cefazolin +/- Aztreonam
Comparators	Vancomycin +/- Aztreonam or Cefazolin +/- Aztreonam	Vancomycin +/- Aztreonam Cefazolin +/- Aztreonam
Ceftaroline fosamil	Ceftaroline fosamil	-

Primary Outcome Measures

Name	Time	Method
Evaluate the safety and tolerability of ceftaroline versus comparator in pediatric subjects ages 2 months to < 18 years with ABSSSI.	Between 26 and 50 days.	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.

Secondary Outcome Measures

Name	Time	Method
Evaluate the efficacy of ceftaroline versus comparator in pediatric subjects ages 2 months to < 18 years with ABSSSI.	Between 1 and 5 days	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.	Between 1 and 5 days	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)

Trial Locations

Locations (71)

Investigational Site - Morgantown; 🇺🇸 Morgantown, West Virginia, United States

Investigational Site - Tbilisi 2; 🇬🇪 Tbilisi, Georgia

Investigational Site - Bydgoszcz 2; 🇵🇱 Bydgoszcz, Poland

Investigational Site - Bucharest 1; 🇷🇴 Bucharest, Romania

Investigational Site - Tirgu Mures; 🇷🇴 Tirgu Mures, Romania

Investigational Site - Vina Del Mar; 🇨🇱 Vina del Mar, Chile

Investigational Site - Tbilisi 1; 🇬🇪 Tbilisi, Georgia

Investigational Site - Riga; 🇱🇻 Riga, Latvia

Investigational Site - Lodz; 🇵🇱 Lodz, Poland

Investigational Site - Cape Town 1; 🇿🇦 Cape Town, South Africa

Investigational Site - Madrid 2; 🇪🇸 Madrid, Spain

Investigational Site - Johannesburg; 🇿🇦 Johannesburg, South Africa

Investigational Site - Liepaja; 🇱🇻 Liepaja, Latvia

Investigational Site - Rezekne; 🇱🇻 Rezekne, Latvia

Investigational Site - Kaunas; 🇱🇹 Kaunas, Lithuania

Investigational Site - Madrid 1; 🇪🇸 Madrid, Spain

Investigational Site - Getafe; 🇪🇸 Getafe, Spain

Investigational Site - Daugavpils; 🇱🇻 Daugavpils, Latvia

Investigational Site - Madrid 3; 🇪🇸 Madrid, Spain

Investigational Site - Cape Town 2; 🇿🇦 Cape Town, South Africa

Investigational Site - Badalona; 🇪🇸 Badalona, Spain

Investigational Site - Esplugues de Llobregat; 🇪🇸 Esplugues de Llobregat, Spain

Investigational Site - Rzeszow; 🇵🇱 Rzeszow, Poland

Investigational Site - Constanta; 🇷🇴 Constanta, Romania

Investigational Site - Cape Town 3; 🇿🇦 Cape Town, South Africa

Investigational Site - Valencia; 🇪🇸 Valencia, Spain

Investigational Site - Seattle; 🇺🇸 Seattle, Washington, United States

Investigational Site - Phoenix; 🇺🇸 Phoenix, Arizona, United States

Investigational Site - Vitacura; 🇨🇱 Vitacura, Santiago, Chile

Investigational Site - Bydgoszcz 1; 🇵🇱 Bydgoszcz, Poland

Investigational Site - Timisoara; 🇷🇴 Timisoara, Romania

Investigational Site - Vilnius; 🇱🇹 Vilnius, Lithuania

Investigational Site - Lublin; 🇵🇱 Lublin, Poland

Investigational Site - Warszawa; 🇵🇱 Warszawa, Poland

Investigational Site - Bucharest 2; 🇷🇴 Bucharest, Romania

Investigational Site - Orange; 🇺🇸 Orange, California, United States

Investigational Site - Jacksonville; 🇺🇸 Jacksonville, Florida, United States

Investigational Site - San Diego; 🇺🇸 San Diego, California, United States

Investigational Site - Chicago 2; 🇺🇸 Chicago, Illinois, United States

Investigational Site - Atlanta; 🇺🇸 Atlanta, Georgia, United States

Investigational Site - Chicago 1; 🇺🇸 Chicago, Illinois, United States

Investigational Site - Springfield; 🇺🇸 Springfield, Illinois, United States

Investigational Site - Shreveport; 🇺🇸 Shreveport, Louisiana, United States

Investigational Site - Baltimore; 🇺🇸 Baltimore, Maryland, United States

Investigational Site - Detroit; 🇺🇸 Detroit, Michigan, United States

Investigational Site - Bronx; 🇺🇸 Bronx, New York, United States

Investigational Site - Brooklyn; 🇺🇸 Brooklyn, New York, United States

Investigational Site - New Hyde Park; 🇺🇸 New Hyde Park, New York, United States

Investigational Site - Rochester; 🇺🇸 Rochester, New York, United States

Investigational Site - Cleveland 1; 🇺🇸 Cleveland, Ohio, United States

Investigational Site - Cleveland 2; 🇺🇸 Cleveland, Ohio, United States

Investigational Site - Toledo; 🇺🇸 Toledo, Ohio, United States

Investigational Site - Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States

Investigational Site - Memphis; 🇺🇸 Memphis, Tennessee, United States

Investigational Site - Norfolk; 🇺🇸 Norfolk, Virginia, United States

Investigational Site - Buenos Aires 1; 🇦🇷 Buenos Aires, Argentina

Investigational Site - Buenos Aires 2; 🇦🇷 Buenos Aires, Argentina

Investigational Site - Buenos Aires 3; 🇦🇷 Buenos Aires, Argentina

Investigational Site - Buenos Aires 4; 🇦🇷 Buenos Aires, Argentina

Investigational Site - Buenos Aires 5; 🇦🇷 Buenos Aires, Argentina

Investigational Site - Buenos Aires 6; 🇦🇷 Buenos Aires, Argentina

Investigational Site - Puente Alto; 🇨🇱 Puente Alto, Santiago, Chile

Investigational Site - Santa Fe 1; 🇦🇷 Santa Fe, Argentina

Investigational Site - Santa Fe 2; 🇦🇷 Santa Fe, Argentina

Investigational Site - San Ramon; 🇨🇱 San Ramon, Santiago, Chile

Investigational Site - Akron; 🇺🇸 Akron, Ohio, United States

Investigational Site - Fort Worth; 🇺🇸 Fort Worth, Texas, United States

Investigational Site - Santiago de Compostela; 🇪🇸 Santiago de Compostela, Spain

Investigational Site - Charleston; 🇺🇸 Charleston, South Carolina, United States

Investigational Site - Austin 1; 🇺🇸 Austin, Texas, United States

Investigational Site - Richmond; 🇺🇸 Richmond, Virginia, United States