Clinical Trials Register

Summary
EudraCT Number:	2011-002198-44
Sponsor's Protocol Code Number:	P903-21
Clinical Trial Type:	Outside EU/EEA
Date on which this record was first entered in the EudraCT database:	2011-07-22
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED

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A. Protocol Information

A.2

EudraCT number

2011-002198-44

A.3

Full title of the trial

Pharmacokinetics of a Single Dose of Ceftaroline
fosamil in Children Ages Birth to Younger Than 12
Years With Suspected or Confirmed Infection

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

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

A.3.2

Name or abbreviated title of the trial where available

Pharmacokinetics of a Single Dose of Ceftaroline fosamil in Children

A.4.1

Sponsor's protocol code number

P903-21

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT01298843

A.7

Trial is part of a Paediatric Investigation Plan

Yes

A.8

EMA Decision number of Paediatric Investigation Plan

P/158/2010

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Cerexa, Inc. (subsidary of Forest Laboratories)
B.1.3.4	Country	United States
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Cerexa, Inc. (subsidary of Forest Laboratories)
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Cerexa, Inc. (subsidary of Forest Laboratories)
B.5.2	Functional name of contact point	Kristina Haeckl
B.5.3	Address:
B.5.3.1	Street Address	2100 Franklin St Suite 900
B.5.3.2	Town/ city	Oakland
B.5.3.3	Post code	94612
B.5.3.4	Country	United States
B.5.4	Telephone number	5102859228
B.5.5	Fax number	5102859482
B.5.6	E-mail	khaeckl@cerexa.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Ceftaroline fosamil
D.3.4	Pharmaceutical form	Powder for concentrate for solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	ceftaroline fosamil for injection
D.3.9.1	CAS number	CAS 229016-7
D.3.9.2	Current sponsor code	ceftaroline fosamil
D.3.9.3	Other descriptive name	PPI-0903, TAK-599, ceftaroline acetate
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	600
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Pharmacokinetics of a Single Dose of Ceftaroline
fosamil in Children Ages Birth to Younger Than 12
Years With Suspected or Confirmed Infection

E.1.1.1

Medical condition in easily understood language

Infections

E.1.1.2

Therapeutic area

Diseases [C] - Bacterial Infections and Mycoses [C01]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.0
E.1.2	Level	SOC
E.1.2	Classification code	10021881
E.1.2	Term	Infections and infestations
E.1.2	System Organ Class	10021881 - Infections and infestations

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To evalutate the single-dose pharmacokinetic profile, safety and
tolerability of ceftaroline fosamil administered by intravenous infusion
in children with ages from birth to younger than 12 years

E.2.2

Secondary objectives of the trial

E.2.3

Trial contains a sub-study

E.3

Principal 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

E.4

Principal exclusion criteria

1. History of any hypersensitivity or allergic reaction to any β-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

E.5 End points

E.5.1

Primary end point(s)

The Safety Population (all subjects who receive any amount of
ceftaroline fosamil)
PK Analysis Population (all subjects who received the entire
ceftaroline fosamil infusion on
Study Day 1 and from whom any PK samples are collected)
Outcome Variables:
• Evaluation of pharmacokinetics (Cmax, AUC, clearance and T½ will
be derived from population PK
analysis)
• Plasma concentrations-time profiles of ceftaroline by patient, age
cohort, and dosage level
• Evaluation of safety and tolerablility of ceftaroline following a single dose

E.5.1.1

Timepoint(s) of evaluation of this end point

Up to 5 days

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

Yes

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

E.8.1.1

Randomised

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

E.8.3

Will this trial be conducted at a single site globally?

E.8.4

Will this trial be conducted at multiple sites globally?

E.8.6 Trial involving sites outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

Yes

E.8.6.3

Specify the countries outside of the EEA in which trial sites are planned

United States

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

E.8.9 Initial estimate of the duration of the trial

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

Yes

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

Yes

F.1.1.2.1

Number of subjects for this age range:

F.1.1.3

Newborns (0-27 days)

Yes

F.1.1.3.1

Number of subjects for this age range:

F.1.1.4

Infants and toddlers (28 days-23 months)

Yes

F.1.1.4.1

Number of subjects for this age range:

F.1.1.5

Children (2-11years)

Yes

F.1.1.5.1

Number of subjects for this age range:

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

F.1.3

Elderly (>=65 years)

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

Yes

F.3.3.6.1

Details of subjects incapable of giving consent

informed consent from parent(s) or a legal guardian will be obtained
for each subject. Informed assent will be obtained from subjects
capable of giving one

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.2

For a multinational trial

F.4.2.2

In the whole clinical trial

G. Investigator Networks to be involved in the Trial
G.4 Investigator Network to be involved in the Trial: 1

H.4 Third Country in which the Trial was first authorised
H.4.1	Third Country in which the trial was first authorised:	United States

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