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NCT01669980 Clinical Trial

Safety and Efficacy Study of Ceftaroline Versus a Comparator in Pediatric Subjects With Complicated Community Acquired Pneumonia (CABP)

Pneumonia Clinical Trial

Official title:
A Multicenter, Randomized, Observer-Blinded, Active-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Ceftaroline Versus Ceftriaxone Plus Vancomycin in Pediatric Subjects With Complicated Community-acquired Bacterial Pneumonia (CABP)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01669980
Other study ID # P903-24
Secondary ID
Status Completed
Phase Phase 4
First received August 17, 2012
Last updated October 5, 2015
Start date October 2012
Est. completion date August 2014

Study information
Verified date October 2015
Source Forest Laboratories
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationUnited States: Institutional Review BoardRomania: National Agency for Medicines and Medical DevicesRomania: Ethics CommitteeArgentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Study type Interventional

Clinical Trial Summary

This is a study of safety and effectiveness of ceftaroline fosamil in children with Complicated Community-acquired Pneumonia receiving antibiotic therapy in the hospital.

Description:

To evaluate safety, effectiveness, pharmacokinetics and tolerance of ceftaroline fosamil in pediatric subjects ages 2 months to < 18 years who are initially hospitalized with Complicated Community Acquired Bacterial Pneumonia (CABP) at high risk of infection due to methicillin-resistant Staphylococcus aureus (MRSA)

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date August 2014
Est. primary completion date May 2014
Accepts healthy volunteers No
Gender Both
Age group 2 Months to 18 Years
Eligibility Inclusion Criteria:

- Presence of CABP warranting 3 days of initial hospitalization

- Confirmed presence of indicators of complicated CABP

Exclusion Criteria:

- Hypersensitivity or allergic reaction to vancomycin or any ß-lactam antimicrobial

- Confirmed or suspected infection with a pathogen known to be resistant to IV study drugs or known infection at baseline with a sole atypical organism

- Confirmed or suspected respiratory tract infection attributable to sources other than community acquired bacterial pneumonia

- Non-infectious causes of pulmonary infiltrates

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Ceftaroline fosamil
Subjects = 6 months: IV ceftaroline fosamil 15 mg/kg (or 600 mg if > 40 kg) infused over 120 (± 10) minutes q8h (± 1 hour) Subjects < 6 months: IV ceftaroline fosamil 10 mg/kg infused over 120 (± 10) minutes q8h (± 1 hour) Optional Oral Switch: PO amoxicillin clavulanate 45 to 90 mg/kg/day divided q12h PO clindamycin 13 mg/kg/dose PO linezolid 600 mg q12h (Cohort 1) or 10 mg/kg q8h
• IV Ceftriaxone and Vancomycin
IV ceftriaxone 75 mg/kg/day (up to 4 g/day) divided equally every 12 hours (q12h) (± 2 hours) infused over 30 (± 10) minutes AND IV vancomycin 15 mg/kg every 6 hours (q6h) (± 1 hour) infused over at least 60 minutes. Optional Oral Switch: PO amoxicillin clavulanate 45 to 90 mg/kg/day divided q12h PO clindamycin 13 mg/kg/dose PO linezolid 600 mg q12h (Cohort 1) or 10 mg/kg q8h

Locations
Country Name City State
Argentina Investigative Site Buenos Aires
Georgia Investigational Site 1 Tbilisi
Georgia Investigational Site 2 Tbilisi
Georgia Investigational Site 3 Tbilisi
Ukraine Investigational Site Donetsk
Ukraine Investigational Site Ivano-Frankivsk
Ukraine Investigational Site Kryvyi Rih
Ukraine Investigational Site Kyiv
United States Investigational Site Boston Massachusetts
United States Investigational Site Cleveland Ohio
United States Investigational Site Long Beach California
United States Investigational Site Memphis Tennessee
United States Investigational Site Morgantown West Virginia
United States Investigational Site Norfolk Virginia
United States Investigational Site Orange County California
United States Investigational Site Pittsburgh Pennsylvania
United States Investigational Site San Diego California
United States Investigational Site Toledo Ohio

Sponsors (1)
Lead Sponsor Collaborator
Forest Laboratories

Countries where clinical trial is conducted

United States,  Argentina,  Georgia,  Ukraine, 

Outcome
Type Measure Description Time frame Safety issue
Primary Evaluate the safety and tolerability of ceftaroline versus ceftriaxone plus vancomycin in pediatric subjects ages 2 months to < 18 years with complicated community-acquired bacterial pneumonia (CABP) Evaluate the safety and tolerability of IV administered ceftaroline fosamil in children with complicated CABP. Summaries of patient AEs, SAEs, deaths, discontinuations due to AEs, laboratory evaluations (hematology studies, comprehensive and metabolic panel), and vital signs will be provided for each treatment group. between 1 and 57 days Yes
Secondary To evaluate the efficacy of ceftaroline versus ceftriaxone plus vancomycin in pediatric subjects with complicated CABP at high risk of infection due to methicillin-resistant Staphylococcus aureus (MRSA). Evaluate the efficacy of ceftaroline versus ceftriaxone plus vancomycin in pediatric subjects with complicated CABP at high risk of infection due to methicillin-resistant Staphylococcus aureus (MRSA) by assessing clinical stability of the subject at study day 4 and clinical outcome at End of IV, End of Treatment and Test of Cure. between 4 and 57 days No
Secondary Evaluate the pharmacokinetics of ceftaroline in pediatric subjects with complicated CABP at high risk of infection due to methicillin-resistant Staphylococcus aureus (MRSA) Analyze concentrations of ceftaroline, ceftaroline fosamil (prodrug), and ceftaroline M-1 (inactive metabolite) in plasma, and, if available, in cerebrospinal fluid (CSF, if collected as part of standard of care) between 4 and 57 days No
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