Skin Infection Treatment with Ceftaroline – Phase II

A Study to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetics of Ceftaroline Versus Comparator in Pediatric Subjects With Acute Bacterial Skin and Skin Structure Infections

Protocol Description

This multicenter study is being done to learn more about the drug ceftaroline fosamil when used to treat children with acute bacterial skin infections. Ceftaroline fosamil, also called “ceftaroline” and known by the brand name Teflaro®, is an antibiotic. Ceftaroline has been approved to treat adults with community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections (ABSSSI). However, the drug has not been approved for use in infants, children and teens.

Study Level: Phase II

Eligibility Criteria

Subject to certain exclusion criteria, this study is open to infants, children and teens through age 17, who have an ABSSSI skin infection caused by the fungus Candida and requiring antibiotic treatment in the hospital.
Males and Females: Ages 2 months through 17 years

Requirements

Following the initial screening exam, participants will be randomly selected to receive either the study drug or cefazolin or vancomycin, both of which are approved for treatment of this condition. Drugs will be administered intravenously (IV) for at least the first 3 days in the hospital, after which the study doctor will determine whether the patient can be switched to oral dosages and whether a longer hospital stay will be required. All participants will be treated for 5 to 14 days.
Visits: Participants will be initially treated while in the hospital, but some may be able to complete study medication on an outpatient basis, as determined by the study doctor.
Duration: 26 to 50 days, depending on response to treatment

Status: Open for Enrollment

Source(s) of Support

Cerexa, Inc.

Primary Investigator

Judith Martin, MD

Contact Information

For enrollment information, please contact:
Diane Gwin, RN, BSN, MSN, CCRC
412-692-6744
Noreen Jeffrey, RN
412-692-6786