Clinical Trials Register

Summary
EudraCT Number:	2019-001134-33
Sponsor's Protocol Code Number:	012329
National Competent Authority:	Denmark - DHMA
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2019-03-15
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

Denmark - DHMA

A.2

EudraCT number

2019-001134-33

A.3

Full title of the trial

Does repeated administration of cefuroxime after orthopedic surgery provide a better prophylactic profile regarding postoperativ infection than a single administration of preoperative antimicrobial ?
- A micro dialysis study assessing the concentration of antibiotics in bone, synovial sheath, and subcutaneous tissue after trapeziectomy

Medfører gentagen dosis af cefuroxim efter ortopædkirurgisk operation en bedre forebyggelse af infektion end præoperativ antibiotikaprofylakse alene?
‐ Et mikrodialysestudie med måling af antibiotikakoncentration i knogle, seneskede og bløddele efter trapezektomi

A.3.1

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

A.3.2

Name or abbreviated title of the trial where available

MANUS

A.4.1

Sponsor's protocol code number

012329

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	Aarhus University Hospital
B.1.3.4	Country	Denmark
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	Aarhus University Hospital
B.4.2	Country	Denmark
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Aarhus University Hospital
B.5.2	Functional name of contact point	Andrea René Jørgensen
B.5.3	Address:
B.5.3.1	Street Address	Palle Juul-Jensens Boulevard 99
B.5.3.2	Town/ city	Aarhus N
B.5.3.3	Post code	8200
B.5.3.4	Country	Denmark
B.5.4	Telephone number	004551955640
B.5.6	E-mail	anjo@clin.au.dk

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	Cefuroxime
D.2.1.1.2	Name of the Marketing Authorisation holder	B. Braun
D.2.1.2	Country which granted the Marketing Authorisation	Denmark
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.3.4	Pharmaceutical form	Powder and solvent 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	Cefuroxime
D.3.9.1	CAS number	55268-75-2
D.3.9.3	Other descriptive name	CEFUROXIME
D.3.9.4	EV Substance Code	SUB07433MIG
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	1500
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

Orthopedic infections.

ortopædkirurgiske infektioner.

E.1.1.1

Medical condition in easily understood language

Infections that are either related to orthopedic surgery or simply affects the bone.

Infektioner som er relateret til ortopædkirurgiske indgreb eller infektioner lokaliseret i knoglen.

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	20.0
E.1.2	Level	LLT
E.1.2	Classification code	10043658
E.1.2	Term	Thumb osteoarthritis
E.1.2	System Organ Class	100000004859

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

The objectives of the trial are to asses the penetration of cefuroxime when it is administered as either a single administration or as repeated administration, into bone, synovial sheath, and subcutaneous tissue with the use of the pharmacokinetic sampling method, micro dialysis. The primary endpoints are the time for which the concentration of cefuroxime is above the minimal inhibitory concentration (T>MIC) and penetration ratios. The secondary endpoints are standard pharmacokinetic parametres such as; half-life, Cmax, Tmax and AUC.

Formålet med dette studie er at undersøge penetrationen af cefuroxim til knogle- og senevæv samt subcutis, når det administreres hhv. én eller to gange, sidstnævnt med et doseringsinterval på 4 timer. Dette undersøges vha. mikrodialyse. De primære endepunkter er tiden, hvor koncentrationen af cefuroxim ligger over minimal inhibitory concentration (T>MIC) samt penetrations ratioer. Sekundære endepunkter er farmakokinetiske parametre så som: halveringstid, Cmax, Tmax og AUC.

E.2.2

Secondary objectives of the trial

not applicable.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- signed informed consent
- age minimun 18 years
- elective trapeziectomy at the Department of Orthopedic Surgery, Aarhus University Hospital
- Normal liver- and kidney numbers
- Fertile women have to use safe contraception. Fertile women, who do not use safe contraception will have to perform a urin-hCG.

- Underskrevet informeret samtykke.
- Planlagt trapezektomi på Ortopædkirurgisk Afdeling, Aarhus Universitetshospital.
- Alder minimum 18 år.
- Normale nyre- og levertal præoperativt.
- Fertile kvinder skal anvende sikker anti-konception præoperativt. Fertile kvinder, som ikke anvender sikker anti-konception vil få foretaget graviditetstest ved hCG-urinstix.

E.4

Principal exclusion criteria

- Allergy towards antibiotics from the group of beta-lactams (penicillins, cephalosporins, and carbapenems)
- Diabetes
- Previous surgery of the 1. metacarp (concerns the operated hand)
- Previous fracture of the 1. metacarp (concerns the operated hand)
- Previous surgery of the arteries in the arm (concerns the operated hand)
- Treatment with cefuroxime 4 days prior to the surgery

- Allergi for antibiotika fra beta-laktam gruppen (penicilliner, cephalosporiner og carbapenemer).
- Diabetes.
- Tidligere kirurgi i 1. metacarp (gælder den side der skal opereres).
- Tidligere fraktur i 1. metacarp (gælder den side der skal opereres).
- Tidligere arteriel karkirurgi i armen (gælder den side der skal opereres).
- Behandling med cefuroxim de 4 forudgående dage før operationen.

E.5 End points

E.5.1

Primary end point(s)

The primary endpoints are the time for which the concentration of cefuroxime is maintained above til minimal inhibitory concentration (T>MIC) and penetration ratios.

De primære endepunkter er den tid, hvor koncentrationen af cefuroxim er over minimal inhibtory concentration (T>MIC) og penetrationsratioer.

E.5.1.1

Timepoint(s) of evaluation of this end point

Endpoints will be evaluated at the end of the study.

Endepunkterne vil blive evalueret vil studiets ende.

E.5.2

Secondary end point(s)

Standard pharmacokinetic parametres: half life, Cmax, Tmax, and AUC.

Standard farmakokinetiske parametre: halveringstid, Cmax, Tmax og AUC.

E.5.2.1

Timepoint(s) of evaluation of this end point

Endpoints will be evaluated at the end of the study.

Endepunkterne vil blive evalueret vil studiets ende.

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

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

Yes

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

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

Yes

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

Yes

E.8.2.3.1

Comparator description

cefuroxime in other dose.

E.8.2.4

Number of treatment arms in the trial

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

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

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

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)

None.

Ingen.

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

2019-04-09

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2019-06-18

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2021-05-19

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