ICH GCP - EU Clinical trials Registry - 2011-004417-16 (NL)

Summary
EudraCT Number:	2011-004417-16
Sponsor's Protocol Code Number:	5022LC
National Competent Authority:	Netherlands - Competent Authority
Clinical Trial Type:	EEA CTA
Trial Status:
Date on which this record was first entered in the EudraCT database:	2012-06-19
Trial 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
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

A. Protocol Information

A.1

Member State Concerned

Netherlands - Competent Authority

A.2

EudraCT number

2011-004417-16

A.3

Full title of the trial

CEFTRIAXONE NEONATAL THERAPY: A RANDOMIZED CONTROLLED TRIAL TO EVALUATE THE EFFECT OF CEFTRIAXONE ON HYPERBILIRUBINEMIA

Ceftriaxon therapie bij neonaten (cefsint): een gerandomiseerd gecontroleerd onderzoek om het effect van ceftriaxon op hyperbilirubinemie te bepalen

A.3.1

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

CEFTRIAXONE NEONATAL THERAPY: A RANDOMIZED CONTROLLED TRIAL TO EVALUATE THE EFFECT OF CEFTRIAXONE ON HYPERBILIRUBINEMIA

Ceftriaxon therapie bij neonaten (cefsint): een gerandomiseerd gecontroleerd onderzoek om het effect van ceftriaxon op hyperbilirubinemie te bepalen

A.3.2

Name or abbreviated title of the trial where available

CEFSINT

A.4.1

Sponsor's protocol code number

5022LC

A.7

Trial is part of a Paediatric Investigation Plan

No

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	St. Elisabeth Hospital
B.1.3.4	Country	Netherlands
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	St. Elisabeth hospital
B.4.2	Country	Netherlands
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	St. Elisabeth Hospital
B.5.2	Functional name of contact point	Dr. Obihara, pediatrician
B.5.3	Address:
B.5.3.1	Street Address	Hilvarenbeeksweg 60
B.5.3.2	Town/ city	Tilburg
B.5.3.3	Post code	5000 LC
B.5.3.4	Country	Netherlands
B.5.4	Telephone number	00310135392953
B.5.5	Fax number	00310133539433
B.5.6	E-mail	c.obihara@elisabeth.nl

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	Yes
D.2.1.1.1	Trade name	Rocephin
D.2.1.1.2	Name of the Marketing Authorisation holder	unknown
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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	Ceftriaxone
D.3.2	Product code	J01DD04
D.3.4	Pharmaceutical form	Concentrate for suspension for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Auricular use Intravenous use
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

Hyperbilirubinemia

Geelzucht

E.1.1.1

Medical condition in easily understood language

Jaundice

E.1.1.2

Therapeutic area

Diseases [C] - Digestive System Diseases [C06]

MedDRA Classification

E.1.3

Condition being studied is a rare disease

No

E.2 Objective of the trial

E.2.1

Main objective of the trial

development of neonatal hyperbilirubinaemia requiring antibiotic treatment

Ontwikkeling van neonatale hyperbilirubinemie tijdens de antiobitische behandeling

E.2.2

Secondary objectives of the trial

development of pseudolithiasis in the biliary and urogenital tracts

Ontwikkelen van pseudolithiasis in het galwegsysteem en urinewegsysteem

E.2.3

Trial contains a sub-study

No

E.3

Principal inclusion criteria

All neonates, 0-28 days old, with a gestational age (GA) of ≥ 34 weeks, admitted to the neonatal unit and requiring antibiotic treatment for a serious bacterial infection

Alle neonaten, 0- 28 dagen oud, geboren na een zwangerschapsduur van meer dan 34 weken, opgenomen op de neonatale afdeling, antibiotische behandeling wegens een ernstig bacteriele infectie.

E.4

Principal exclusion criteria

Gestational age <34 weeks; congenital malformations; erythrocyte transfusion; blood group or other types of antibody antagonism; haemoglobinopathy; malignancy; serious perinatal asphyxia ; concomitant use of intravenous calcium containing solutions (intravenous fluid or total parenteral nutrition) or transfer to another hospital before completion of study.

Zwangerschapsduur van < 34 weken, congenitale malformaties, erytrocytentransfusie, bloedgroep antagonisme, antilichaam antagonisme, hemoglobiopathie, maligniteit, ernstig perinatale asfyxie, tegelijktijdige toediening van intraveneuze calcium bevattende oplossingen (intravenous of bij totale parenterale voeding), verplaatsing naar een ander ziekenhuis voor het voltooien van de studie bij deze patient

E.5 End points

E.5.1

Primary end point(s)

the incidence of hyperbilirubinemia between neonates treated with ceftriaxon- augmentin combination and those treated with tobramycin- augmentin combination.

Incidentie van hyperbilirubinemie tussen neonaten behandeld met ceftriaxon-augmentin en de incidentie van hyperbilirubinemie bij de groep patienten behandeld met tobramycine-augmentin combinatie

E.5.1.1

Timepoint(s) of evaluation of this end point

Day 1, day 3 and day 7.

Dag 1, dag 3 en dag 7.

E.5.2

Secondary end point(s)

Incidence of pseudolithiasis of the biliary and urogenital tract and laboratory abnormalities between neonates treated with CFT-AUGM combination and those treated with TOBI-AUGM combination.

Incidentie van pseudolithiasis van het galwegsysteem en urogenitaal systeem en laboratoriumafwijkingen vergelijken tussen de groep neonaten behandeld met combinatie van ceftriaxon-augmentin en de groep patienten behandeld met de combinatie tobramycine-augmentin.

E.5.2.1

Timepoint(s) of evaluation of this end point

Day 1, day 3 and day 7.

Dag 1, dag 3 en dag 7.

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

No

E.6.2

Prophylaxis

No

E.6.3

Therapy

No

E.6.4

Safety

Yes

E.6.5

Efficacy

No

E.6.6

Pharmacokinetic

No

E.6.7

Pharmacodynamic

No

E.6.8

Bioequivalence

No

E.6.9

Dose response

No

E.6.10

Pharmacogenetic

No

E.6.11

Pharmacogenomic

No

E.6.12

Pharmacoeconomic

No

E.6.13

Others

No

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

No

E.7.1.1

First administration to humans

No

E.7.1.2

Bioequivalence study

No

E.7.1.3

Other

No

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

No

E.7.3

Therapeutic confirmatory (Phase III)

No

E.7.4

Therapeutic use (Phase IV)

Yes

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

No

E.8.1.3

Single blind

Yes

E.8.1.4

Double blind

No

E.8.1.5

Parallel group

No

E.8.1.6

Cross over

No

E.8.1.7

Other

No

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

E.8.2.2

Placebo

No

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

tobramycine-augmentin

Tobramycin-augmentin

E.8.2.4

Number of treatment arms in the trial

2

E.8.3

The trial involves single site in the Member State concerned

Yes

E.8.4

The trial involves multiple sites in the Member State concerned

No

E.8.5

The trial involves multiple Member States

No

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

No

E.8.6.2

Trial being conducted completely outside of the EEA

No

E.8.7

Trial has a data monitoring committee

No

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

LVLS

Laatste bezoek van de laatste deelnemer

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

0

E.8.9.1

In the Member State concerned months

6

E.8.9.1

In the Member State concerned days

0

E.8.9.2

In all countries concerned by the trial years

0

E.8.9.2

In all countries concerned by the trial months

6

E.8.9.2

In all countries concerned by the trial days

0

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

Yes

F.1.1

Number of subjects for this age range:

150

F.1.1.1

In Utero

No

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:

20

F.1.1.3

Newborns (0-27 days)

Yes

F.1.1.3.1

Number of subjects for this age range:

150

F.1.1.4

Infants and toddlers (28 days-23 months)

No

F.1.1.5

Children (2-11years)

No

F.1.1.6

Adolescents (12-17 years)

No

F.1.2

Adults (18-64 years)

No

F.1.3

Elderly (>=65 years)

No

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

No

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

No

F.3.3.1

Women of childbearing potential not using contraception

No

F.3.3.2

Women of child-bearing potential using contraception

No

F.3.3.3

Pregnant women

No

F.3.3.4

Nursing women

No

F.3.3.5

Emergency situation

No

F.3.3.6

Subjects incapable of giving consent personally

No

F.3.3.7

Others

No

F.4 Planned number of subjects to be included

F.4.1

In the member state

150

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

None

Geen

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

N.

Competent Authority Decision

Authorised

N.

Date of Competent Authority Decision

2012-06-19

N.

Ethics Committee Opinion of the trial application

N.

Ethics Committee Opinion: Reason(s) for unfavourable opinion

N.

Date of Ethics Committee Opinion

P. End of Trial
P.	End of Trial Status

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