Study of Blood Levels of Ceftaroline fosamil in Children who arereceiving anitbiotic Therapy in the Hospital

• Conditions: Pharmacokinetics of a Single Dose of Ceftarolinefosamil in Children Ages Birth to Younger Than 12Years With Suspected or Confirmed Infection; MedDRA version: 14.0Level: SOCClassification code 10021881Term: Infections and infestationsSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2011-002198-44-Outside-EU/EEA
• Lead Sponsor: Cerexa, Inc. (subsidary of Forest Laboratories)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07-22
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

1. Written informed consent from parent(s) (or other legally acceptable
representative[s]) and verbal informed assent from subject (if age
appropriate; according to local requirements)
2. Male or female children with ages from birth to younger than 12
years
3. Hospitalized and receiving antibiotic therapy for treatment of a
suspected or confirmed systemic
4. Negative urine pregnancy test (if female and has reached menarche)
5. Sufficient intravascular access (peripheral or central) to receive
study drug
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. History of any hypersensitivity or allergic reaction to any ß-lactam
antimicrobial (eg, cephalosporins, penicillins)
2. Past or current history of epilepsy or seizure disorder (excluding
childhood febrile seizures)
3. Moderate or severe renal impairment such that: ? Cohorts 1, and 2 ,
and 3: Creatinine clearance (CrCl) < 50 mL/min
calculated using the modified Schwartz equation (Schwartz et al, 1987):
CrCl (mL/min/1.73m2) = [length (cm) x k] / Serum creatinine
(mg/dL)
where:
- k = 0.45 for infants 1 to 52 weeks old
- k = 0.55 for children 1 to 12 years old
? Cohorts 4 and 5:
- Urine output with value of < 1 mL/min/kg (measured in diapered
children as diaper weight
change where 1 g = 1 mL of urine) and
- Serum creatinine value of > 1.3 mg/dL
Note: For Cohort 3, if calculated CrCl is between 50-60
mL/min/1.73m2, and the child is age
24 months or under, please ensure urine output and serum creatinine
values are within normal or mild renal impairment criteria as for
Cohorts 4 and 5 (ie, urine output = 1mL/kg/min [measured in diapered
children as diaper weight change where 1 g = 1 mL of urine] and serum
creatinine = 1.3 mg/dL)
4. Aspartate aminotransferase, alanine aminotransferase, or total
bilirubin level > 3 times upper limit of
normal (neonates with elevated total bilirubin may participate if
conjugated bilirubin is normal)
5. Any condition (eg, septic shock, acute hemodynamic instability
including those requiring pressor
support) that would make the subject, in the opinion of the
Investigator, unsuitable for the study (eg,
would place a subject at risk or compromise the quality of the data)
6. Receipt of a blood transfusion during the 24-hour period before
enrollment
7. Use of probenecid within 3 days prior to dosing
8. If female, currently pregnant or nursing
9. Previous participation in this study or in any study involving
administration of an investigational agent
within 30 days prior to enrollment into this study where the subject
was randomized and received an
active investigational product (not placebo)
10. Unwilling or unable to adhere to study procedures or restrictions

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evalutate the single-dose pharmacokinetic profile, safety and<br>tolerability of ceftaroline fosamil administered by intravenous infusion<br>in children with ages from birth to younger than 12 years;Secondary Objective: ;Primary end point(s): The Safety Population (all subjects who receive any amount of<br>ceftaroline fosamil)<br>PK Analysis Population (all subjects who received the entire<br>ceftaroline fosamil infusion on<br>Study Day 1 and from whom any PK samples are collected)<br>Outcome Variables:<br>• Evaluation of pharmacokinetics (Cmax, AUC, clearance and T½ will<br>be derived from population PK<br>analysis)<br>• Plasma concentrations-time profiles of ceftaroline by patient, age<br>cohort, and dosage level<br>• Evaluation of safety and tolerablility of ceftaroline following a single dose<br><br>;Timepoint(s) of evaluation of this end point: Up to 5 days