Infections, Pediatrics Clinical Trial
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
| Verified date | January 2015 |
| Source | Forest Laboratories |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 163 |
| Est. completion date | July 2014 |
| Est. primary completion date | May 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 2 Months to 17 Years |
| Eligibility |
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 ß-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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Argentina | 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 - Santa Fe 1 | Santa Fe | |
| Argentina | Investigational Site - Santa Fe 2 | Santa Fe | |
| Chile | Investigational Site - Puente Alto | Puente Alto | Santiago |
| Chile | Investigational Site - San Ramon | San Ramon | Santiago |
| Chile | Investigational Site - Vina Del Mar | Vina del Mar | |
| Chile | Investigational Site - Vitacura | Vitacura | Santiago |
| Georgia | Investigational Site - Tbilisi 1 | Tbilisi | |
| Georgia | Investigational Site - Tbilisi 2 | Tbilisi | |
| Latvia | Investigational Site - Daugavpils | Daugavpils | |
| Latvia | Investigational Site - Liepaja | Liepaja | |
| Latvia | Investigational Site - Rezekne | Rezekne | |
| Latvia | Investigational Site - Riga | Riga | |
| Lithuania | Investigational Site - Kaunas | Kaunas | |
| Lithuania | Investigational Site - Vilnius | Vilnius | |
| Poland | Investigational Site - Bydgoszcz 1 | Bydgoszcz | |
| Poland | Investigational Site - Bydgoszcz 2 | Bydgoszcz | |
| Poland | Investigational Site - Lodz | Lodz | |
| Poland | Investigational Site - Lublin | Lublin | |
| Poland | Investigational Site - Rzeszow | Rzeszow | |
| Poland | Investigational Site - Warszawa | Warszawa | |
| Romania | Investigational Site - Bucharest 1 | Bucharest | |
| Romania | Investigational Site - Bucharest 2 | Bucharest | |
| Romania | Investigational Site - Constanta | Constanta | |
| Romania | Investigational Site - Timisoara | Timisoara | |
| Romania | Investigational Site - Tirgu Mures | Tirgu Mures | |
| South Africa | Investigational Site - Cape Town 1 | Cape Town | |
| South Africa | Investigational Site - Cape Town 2 | Cape Town | |
| South Africa | Investigational Site - Cape Town 3 | Cape Town | |
| South Africa | Investigational Site - Johannesburg | Johannesburg | |
| Spain | Investigational Site - Badalona | Badalona | |
| Spain | Investigational Site - Esplugues de Llobregat | Esplugues de Llobregat | |
| Spain | Investigational Site - Getafe | Getafe | |
| Spain | Investigational Site - Madrid 1 | Madrid | |
| Spain | Investigational Site - Madrid 2 | Madrid | |
| Spain | Investigational Site - Madrid 3 | Madrid | |
| Spain | Investigational Site - Santiago de Compostela | Santiago de Compostela | |
| Spain | Investigational Site - Valencia | Valencia | |
| United States | Investigational Site - Akron | Akron | Ohio |
| United States | Investigational Site - Atlanta | Atlanta | Georgia |
| United States | Investigational Site - Austin 1 | Austin | Texas |
| United States | Investigational Site - Baltimore | Baltimore | Maryland |
| United States | Investigational Site - Bronx | Bronx | New York |
| United States | Investigational Site - Brooklyn | Brooklyn | New York |
| United States | Investigational Site - Charleston | Charleston | South Carolina |
| United States | Investigational Site - Chicago 1 | Chicago | Illinois |
| United States | Investigational Site - Chicago 2 | Chicago | Illinois |
| United States | Investigational Site - Cleveland 1 | Cleveland | Ohio |
| United States | Investigational Site - Cleveland 2 | Cleveland | Ohio |
| United States | Investigational Site - Detroit | Detroit | Michigan |
| United States | Investigational Site - Fort Worth | Fort Worth | Texas |
| United States | Investigational Site - Jacksonville | Jacksonville | Florida |
| United States | Investigational Site - Memphis | Memphis | Tennessee |
| United States | Investigational Site - Morgantown | Morgantown | West Virginia |
| United States | Investigational Site - New Hyde Park | New Hyde Park | New York |
| United States | Investigational Site - Norfolk | Norfolk | Virginia |
| United States | Investigational Site - Orange | Orange | California |
| United States | Investigational Site - Phoenix | Phoenix | Arizona |
| United States | Investigational Site - Pittsburgh | Pittsburgh | Pennsylvania |
| United States | Investigational Site - Richmond | Richmond | Virginia |
| United States | Investigational Site - Rochester | Rochester | New York |
| United States | Investigational Site - San Diego | San Diego | California |
| United States | Investigational Site - Seattle | Seattle | Washington |
| United States | Investigational Site - Shreveport | Shreveport | Louisiana |
| United States | Investigational Site - Springfield | Springfield | Illinois |
| United States | Investigational Site - Toledo | Toledo | Ohio |
| Lead Sponsor | Collaborator |
|---|---|
| Forest Laboratories | AstraZeneca |
United States, Argentina, Chile, Georgia, Latvia, Lithuania, Poland, Romania, South Africa, Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Evaluate the safety and tolerability of ceftaroline versus comparator in pediatric subjects ages 2 months to < 18 years with ABSSSI. | 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. | Between 26 and 50 days. | Yes |
| Secondary | Evaluate the efficacy of ceftaroline versus comparator in pediatric subjects ages 2 months to < 18 years with ABSSSI. | 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. | Between 1 and 5 days | No |
| Secondary | Evaluate the pharmacokinetics of ceftaroline versus comparator in pediatric subjects ages 2 months to < 18 years with ABSSSI. | 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) | Between 1 and 5 days | No |