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Completed

NCT Number: NCT00633126

Pharmacokinetics of Ceftaroline in Subjects 12 to 17 Years of Age

The purpose of this study is to determine the pharmacokinetics of ceftaroline in pediatric subjects

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Key information

Conditions

Infection Infections

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Investigational Site, Louisville, Kentucky, United States

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About this study

The purpose of this study is to determine the pharmacokinetics profile of ceftaroline in pediatric subjects

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Hospitalized and receiving antibiotic therapy for treatment of a suspected infection of any type
  • Body mass index (weight [kg]/height squared [m2]) of no more than 30
  • Males and females between 12 and 17 years of age, inclusive

Exclusion criteria

  • History of any hypersensitivity or allergic reaction to any β-lactam antimicrobial
  • Past or current history of epilepsy or seizure disorder
  • Critically ill or unstable patients

Treatment and study plan

ceftaroline

Drug

Single parenteral infusion at a dose of 8 mg/kg for subjects weighing less than 75 kg or at a dose of 600 mg for subjects weighing greater than or equal to 75 kg infused over 60 minutes.

Other names: ceftaroline for injection, ceftaroline fosamil

Primary outcomes

  1. The Maximum Plasma Concentration (Cmax) of Ceftaroline After Administration of Ceftaroline Fosamil at a Dose of 8 mg/kg up to a Maximum Dose of 600 mg Via IV Infusion Over 60 Minutes.

    Time frame: 12 hours after infusion

    The maximum plasma concentration (Cmax ) occurred around the time of the end of study drug infusion.

Secondary outcomes

  1. Number of Adverse Events (AEs) Reported After Starting Study Drug Administration (Treatment Emergent Adverse Events, TEAEs) by Relationship to Ceftaroline (Related or Unrelated).

    Time frame: Signing of Informed Consent Form (ICF) to last follow up (FU) visit, study day 7 (+-2 days).

    A TEAE is any untoward medical occurrence a subject experiences following study drug administration.

    Subjects were monitored for TEAEs from the start of infusion of ceftaroline fosamil on Study Day 1 through the follow-up contact on Day 7.

Sponsors and collaborators

Lead sponsor

Forest Laboratories

Industry

Registry information

Official study title

Pharmacokinetics of a Single Dose of Ceftaroline in Subjects 12 to 17 Years of Age Receiving Antibiotic Therapy

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Mar 11, 2008
Registry last updated
Mar 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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