Clinical Trials Register

Summary
EudraCT Number:	2018-000109-22
Sponsor's Protocol Code Number:	MONATPRO
National Competent Authority:	Czechia - SUKL
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2018-05-02
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

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A. Protocol Information

A.1

Member State Concerned

Czechia - SUKL

A.2

EudraCT number

2018-000109-22

A.3

Full title of the trial

Monitoring of efficacy of antibiotic prophylaxis in thoracic surgery

Monitorace účinnosti antibiotické profylaxe u hrudní chirurgie

A.3.1

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

Monitoring of efficacy of preventive antibiotic administration in thoracic surgery

Sledování účinnosti preventivního podání antibiotik při hrudních operacích

A.3.2

Name or abbreviated title of the trial where available

MONATPRO

A.4.1

Sponsor's protocol code number

MONATPRO

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	Fakultní nemocnice Hradec Králové
B.1.3.4	Country	Czech Republic
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	Kardiochirurgická klinika Fakultní nemocnice Hradec Králové
B.4.2	Country	Czech Republic
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Fakultní nemocnice Hradec Králové
B.5.2	Functional name of contact point	Referát klinických hodnocení
B.5.3	Address:
B.5.3.1	Street Address	Sokolská 581
B.5.3.2	Town/ city	Hradec Králové
B.5.3.3	Post code	50005
B.5.3.4	Country	Czech Republic
B.5.4	Telephone number	420495834250
B.5.6	E-mail	helena.linhartova@fnhk.cz

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	Vulmizolin
D.2.1.1.2	Name of the Marketing Authorisation holder	BB Pharma a.s.
D.2.1.2	Country which granted the Marketing Authorisation	Czech Republic
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	Vulmizolin
D.3.4	Pharmaceutical form	Powder for solution for injection/infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous bolus use (Noncurrent)
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.IMP: 2
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	Azepo
D.2.1.1.2	Name of the Marketing Authorisation holder	MEDOPHARM, s.r.o.
D.2.1.2	Country which granted the Marketing Authorisation	Czech Republic
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	Azepo
D.3.4	Pharmaceutical form	Powder for solution for injection/infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous bolus use (Noncurrent)
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

Antibiotic prophylaxis in thoracic surgery

Antibiotická profylaxe v hrudní chirurgii

E.1.1.1

Medical condition in easily understood language

Antibiotic preventive administration in thoracic surgery

Preventivní podání antibiotik u operací v oblasti hrudníku

E.1.1.2

Therapeutic area

Body processes [G] - Microbiological Phenomena [G06]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	LLT
E.1.2	Classification code	10036894
E.1.2	Term	Prophylactic antibiotic therapy
E.1.2	System Organ Class	100000004865

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Main objective of the trial is to verify whether the antibiotic administration algorithm for prophylactic use in thoracic surgery currently used at the Cardiac surgery department of the University Hospital in Hradec Králové is effective. Furthermore, the aim of this study is to find out whether systemic antibiotic administration reaches sufficient blood levels at the beggining of surgery and corresponds to therapeutic levels that always exceed the minimum inhibitory concentration (MIC).

Cílem studie je ověřit, zda je algoritmus podávání antibiotik k profylaktickým účelům u hrudní chirurgie zavedený v současné době na kardiochirurgické klinice FN HK efektivní. Dále je účelem této studie zjistit, zda systémové podání antibiotika dosahuje v krvi na začátku operace dostatečných hladin a odpovídá hodnotám terapeutických hladin vždy převyšujícím minimální inhibiční koncentraci (MIC).

E.2.2

Secondary objectives of the trial

Secondary objective of this study is to find out whether repeated administration of antibiotics in the current regimen is abundant.

Dalším cílem této studie je zjistit, zda není opakované podání antibiotika ve stávajícím režimu abundantní.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Male and female ≥ 18 years old
2. Selective thoracic surgery with expected lenght more than 1 hour
3. Ability to understand and sign informed consent

1.Muži a ženy od 18 let věku (včetně).
2.Plánovaná hrudní operace s předpokládanou délkou trvání více než 1 hodina.
3.Schopnost porozumět a podepsat informovaný souhlas.

E.4

Principal exclusion criteria

1. Allergy to cefazolin
2. Ongoing infection treated with systemic antibiotics
3. Renal failure with creatinine clearance lower that 35 ml/min/1,73 m2 based on preoperative laboratory results.
4. Pregnant and breastfeeding woman cannot be enrolled to this study. For women of childbearing potential, the pregnancy will be excluded by pregnancy test prior surgery.
5. Patients with contraindications listed in the currently valid SmPC of the investigational products.

1.Alergie na cefazolin.
2.Probíhající infekce léčená systémovými antibiotiky.
3.Selhání ledvin s clearence kreatininu nižší než 35 ml/min/1,73 m2 na základě laboratorních výsledků v rámci předoperačního vyšetření.
4.Studie se nemohou zúčastnit těhotné a kojící ženy. U žen v reprodukčním věku, bude těhotenství vyloučeno provedením těhotenského testu před chirurgickým zákrokem.
5.Pacienti s kontraindikacemi uvedenými v současně platných SmPC hodnocených přípravků.

E.5 End points

E.5.1

Primary end point(s)

Parameters of cephalosporin efficacy are evaluated by monitoring the MIC break point (4 mg /l for MSSA). Efficacy parameters are defined by 20 times the level above the MIC of 4 mg/l.
Blood levels of cephalosporins will be monitored and the level is expected higher than 350 mg/l after intravenous administrated dose 2 grams.

Parametry účinnosti cefalosporinů jsou vyhodnocovány monitorací break pointu MIC, který je nyní pro MSSA stanoven na 4 mg/l. Parametry účinnosti jsou vymezeny 20 násobkem hladiny nad MIC 4 mg/l.
Dále bude sledována hladina cefalosporinů v krvi, kdy očekáváme při dávce 2 g i. v. hodnotu nad 350 mg/l.

E.5.1.1

Timepoint(s) of evaluation of this end point

After all blood samples collection

Po odběru všech vzorků

E.5.2

Secondary end point(s)

No secondary end points

Žádný sekundární endpoint.

E.5.2.1

Timepoint(s) of evaluation of this end point

No secondary end points

Žádný sekundární endpoint.

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

Yes

E.6.3

Therapy

E.6.4

Safety

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

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

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

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

Last patient last blood sample

Poslední krevní odběr u posledního pacienta

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

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 2018-05-02.

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

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

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)

Not applicable

Není aplikováno

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

2018-05-31

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2018-02-08

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2018-12-02

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