Clinical Trials Register

Summary
EudraCT Number:	2015-003171-29
Sponsor's Protocol Code Number:	VANCO-PK/IM_E:005/2015
National Competent Authority:	Germany - BfArM
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2015-11-04
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
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Germany - BfArM

A.2

EudraCT number

2015-003171-29

A.3

Full title of the trial

The correlation between vancomycin AUC and trough levels during
intermittent dosing of vancomycin and plateau levels during continuous
infusion
- Pharmacokinetic evaluation of Vancomycin and the influence of the
antibiotic therapy on the microbioma-

Korrelation zwischen AUC und Serumspiegeln bei der intermittierenden
und kontinuierlichen intravenösen Gabe von Vancomycin
- Prospektive Untersuchung zur Pharmakokinetik von Vancomycin und des
Einflusses der Antibiose auf das Mikrobiom-

A.3.1

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

investigation on blood-levels and excretion of vancomycin (antibiotic
therapy) in dependency on certain parameters (renal function, age, sex
etc.) and the kind of infusion. Investigation on the influence of vancomycin
on the gut flora

Untersuchung zu Blutspiegeln und Ausscheidung von Vancomycin
(Antibiotikum) in Abhängigkeit von bestimmten Parametern
(Nierenfunktion, Alter, Geschlecht etc.) und abhängig von der
Verabreichungsart. Untersuchung des Einflusses von Vancomycin auf die
Darmflora.

A.4.1

Sponsor's protocol code number

VANCO-PK/IM_E:005/2015

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Universitätsklinikum Tübingen
B.1.3.4	Country	Germany
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	DZIF - deutsches Zentrum für Infektionsforschung
B.4.2	Country	Germany
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Universitätsklinikum Tübingen, Medizinische Klinik I
B.5.2	Functional name of contact point	Evelina Tacconelli
B.5.3	Address:
B.5.3.1	Street Address	Otfried-Müller-Str. 12
B.5.3.2	Town/ city	Tübingen
B.5.3.3	Post code	72076
B.5.3.4	Country	Germany
B.5.6	E-mail	stefanie.doebele@med.uni-tuebingen.de

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.2.1.2	Country which granted the Marketing Authorisation	Germany
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	Vancomycin
D.3.4	Pharmaceutical form	Powder for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
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

In patients who receive an antibiotic therapy with vancomycin i.v. (because of an infection) blood-, urine and stool samples are taken at certain time points and data on the pharmakokinetic of vancomycin are raised.

Bei Patienten, die Vancomycin (aufgrund einer Infektion) i.v. erhalten, werden zu bestimmten Zeitpunkten Blut-, Urin,- und Stuhlproben entnommen/untersucht und Daten zur Pharmakokinetik von Vancomycin erhoben.

E.1.1.1

Medical condition in easily understood language

in patients who get a therapy with vancomycin (an antibiotic) intravenously at certain time points blood-, urine and stool samples will be drawn and analyzed to get information on dosing of vancomycin

Bei Patienten, die Vancomycin (ein Antibiotikum) über die Vene erhalten, werden zu bestimmten Zeitpunkten Proben (Blut, Urin, Stuhl) untersucht um Informationen über die optimale Dosierung zu erhalten

E.1.1.2

Therapeutic area

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

MedDRA Classification

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

getting information/prospective data on the pharmkokinetics of vancomycin to develop a new dose calculator of with which - in dependency on age, renal function, weight etc. of the patient - the optimal dosage of vancomycin can be calculated

Ziel der Studie ist es prospektive Daten zur Pharmakokinetik von Vancomycin zu gewinnen anhand derer ein neuer Dosisberechner entwickelt werden kann, mit dem die optimale Dosis von Vancomycin in Abhängigkeit von Körpergewicht, Nierenfunktion etc. berechnet werden kann.

E.2.2

Secondary objectives of the trial

developing a calculator with which the optimal dosing of vancomycin (an antibiotic) can be calculated in dependency on age of the patient, his renal function etc.

Entwicklung eines Dosisberechnungsprogramms mit dessen Hilfe die optimale Dosierung von Vancomycin in Abhängigkeit von Alter, Gewicht, Nierenfunktion etc. berechnet werden kann. Grundlage bilden Daten, die aus Patientenproben gewonnen werden.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Adult hospitalized patients of more than 18 years that are not pregnant and not treated with renal replacement treatment who need a treatment with vancomycin according to their attending physician.

Eingeschlossen werden können Patienten, die mindestens 18 Jahre alt sind, nicht schwanger und nicht dialysepflichtig sind und eine Antibiose mit Vancomycin i.v. erhalten nach Maßgabe ihres behandelnden Arztes.

E.4

Principal exclusion criteria

Exclusion criteria are
age of less than 18 years;
estimated life-expectance of < 48 hours due to major co-morbid conditions;
pregnancy
gE-mediated allergy to vancomycin
patients not giving informed consent
hemoglobin < 10 g/dl

Ausschlusskriterien sind: Alter < 18 Jahre, Schwangerschaft, Dialysepflichtigkeit, fehlende Einverständniserklärung, erwartete Überlebensdauer < 48 Stunden aufgrund schwerer Begleiterkrankungen, IgE vermittelte Allergie auf Vancomycin, Hb < 10 g/dl

E.5 End points

E.5.1

Primary end point(s)

no primary endpoints

keine primären Endpunkte

E.5.1.1

Timepoint(s) of evaluation of this end point

keine primären Endpunkte

no primary endpoints

E.5.2

Secondary end point(s)

no secondary endpoints

keine sekundären Endpunkte

E.5.2.1

Timepoint(s) of evaluation of this end point

no secondary endpoints

keine sekundären Endpunkte

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

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)

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)

Yes

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

The trial involves single site in the Member State concerned

Yes

E.8.4

The trial involves multiple sites in the Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

Yes

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

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

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

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2015-11-04.

Yes

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

Yes

F.3.3.6

Subjects incapable of giving consent personally

Yes

F.3.3.6.1

Details of subjects incapable of giving consent

patients who are not capable of giving informed consent (for example because they have a sepsis and aren't conscious) can be included in the study when their legal or authorized representative gives informed consent

Patienten, die nicht oder eingeschränkt einwilligungsfähig sind (z.B. bei schwerer Sepsis) können in die Studie eingeschlossen werden, wenn ihr gesetzlicher Vertreter oder Bevollmächtigter einer Studienteilnahme nach Aufklärung zustimmt

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

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)

study participants will be treated after the end of their study participation as non-study participants in the same medical condition (inpatients treatment). There are no post trial treatment plans apart from cases, where AEs, that are suspected to be related to the trial participation, occure. In these cases the study participants will be followed up with focus on the AE till resolution of the AE, respectively 14 days after.

die Studienteilnehmer werden nach Ende der Studienteilnahme behandelt wie nicht-Studienteilnehmer in gleicher gesundheitlicher Situation (stationäre Behandlung). Es sind keine Routine-Nachuntersuchungen vorgesehen ausser bei Auftreten von AEs, die wahrscheinlich in kausalem Zusammenhang mit der Studie stehen. In diesem Fall werden die Patienten bis zum Abschluss des AEs bzw. für 14 Tage zielgerichtet nachbeobachtet.

G. Investigator Networks to be involved in the Trial

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

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2015-11-11

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2015-12-17

P. End of Trial
P.	End of Trial Status	Prematurely Ended
P.	Date of the global end of the trial	2016-12-12

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