Clinical Trials Register

Summary
EudraCT Number:	2021-001019-95
Sponsor's Protocol Code Number:	COLIMICINA
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2021-06-08
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

Italy - Italian Medicines Agency

A.2

EudraCT number

2021-001019-95

A.3

Full title of the trial

Pharmacokinetic/pharmacodynamic aspects of colistin intravenous administration in critically ill patients suffering from hospital infections caused by multi-antibiotic-resistant germs and receiving continuous renal replacement therapy.

Aspetti farmacocinetici/farmacodinamici della somministrazione endoveno-sa di colistina in pazienti critici affetti da infezioni ospedaliere causate da germi multi-resistenti agli antibiotici e che ricevono terapia sostitutiva rena-le continua.

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

COLIMICINA

A.4.1

Sponsor's protocol code number

COLIMICINA

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	FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE
B.1.3.4	Country	Italy
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
B.4.2	Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	FONDAZIONE POLICLINICO UNIVERSITARIO A. GEMELLI IRCCS
B.5.2	Functional name of contact point	DIREZIONE SCIENTIFICA
B.5.3	Address:
B.5.3.1	Street Address	LARGO A. GEMELLI 8
B.5.3.2	Town/ city	ROMA
B.5.3.3	Post code	00168
B.5.3.4	Country	Italy
B.5.4	Telephone number	0630155701
B.5.5	Fax number	0630155701
B.5.6	E-mail	MARGHERITA.ZONA@POLICLINICOGEMELLI.IT

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	Italy
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	COLIMICINA
D.3.2	Product code	[COLIMICINA]
D.3.4	Pharmaceutical form	Powder and solvent for solution for injection/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	COLIMICINA
D.3.9.1	CAS number	1264-72-8
D.3.9.2	Current sponsor code	COLIMICINA
D.3.10	Strength
D.3.10.1	Concentration unit	Munit million units
D.3.10.2	Concentration type	up to
D.3.10.3	Concentration number	7
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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

Critically ill patients suffering from hospital infections caused by multi-antibiotic-resistant germs and receiving continuous renal replacement therapy.

Pazienti critici affetti da infezioni ospedaliere causate da germi multi-resistenti agli antibiotici e che ricevono terapia sostitutiva renale continua.

E.1.1.1

Medical condition in easily understood language

Critically ill patients suffering from hospital infections caused by multi-antibiotic-resistant germs and receiving continuous renal replacement therapy.

Pazienti critici affetti da infezioni ospedaliere causate da germi multi-resistenti agli antibiotici e che ricevono terapia sostitutiva renale continua.

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	PT
E.1.2	Classification code	10053840
E.1.2	Term	Bacterial sepsis
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

Primary objective. Describe the pharmacokinetic and pharmacodynamic profile of colistin, determining the drug levels in the plasma compartment of critically ill patients admitted to intensive care, suffering from serious infections that require the use of this drug as well as continuous renal replacement therapy.

L’obiettivo primario dello studio è descrivere il profilo farmacocinetico e farmacodinamico di CL, determinando i livelli di farmaco nel compartimen-to plasmatico dei pazienti critici ricoverati in terapia intensiva, affetti da in-fezioni gravi che richiederanno l’utilizzo di tale farmaco e terapia sostituti-va renale continua

E.2.2

Secondary objectives of the trial

Secondary objectives. In addition, we will evaluate: 1) the extent of colistin removal by continuous renal replacement therapy, 2) the clinical and microbiological response, 3) the emergence of resistant pathogens, 4) the rate of Clostridium difficile infections and 5) any fungal colonization.

L’obiettivo secondario dello studio è valutare l’entità di rimozione della CL da parte della terapia sostitutiva renale continua, la risposta clinica e micro-biologica, l’emergenza di patogeni resistenti, il tasso di infezioni da Clostri-dium difficile e l’eventuale colonizzazione fungina

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

o Age> 18 yy
o Duration of treatment planned for at least 48 hours
o Infection where the involvement of MDR germs is documented or highly probable
o Continuous renal replacement therapy
o Acute renal failure, stage III of the 2012 KDIGO classification
o Half-life of the continuous renal replacement therapy filter less than 48 hours.

• Durata del trattamento con CL previsto per almeno 48 h
• Età >18 aa
• Infezione ove sia documentata o sia altamente probabile il coinvol-gimento di germi MDR
• Terapia sostitutiva renale continua
• Insufficienza renale acuta, stadio III della classificazione KDIGO 2012
• Emivita del filtro per terapia sostitutiva renale continua inferiore a 48

E.4

Principal exclusion criteria

o State of pregnancy
o Refusal of informed consent
o Known hypersensitivity to polymyxins
o Clinical condition with high probability of death, according to Symplified Acute Physiology Score (SAPS II)
o Partial maintenance of renal function, defined by stages I and II of the 2012 KDIGO classification.
o Renal replacement therapy filter other than AN69 ST 150

• Stato di gravidanza
• Rifiuto del consenso informato
• Nota ipersensibilità alle polimixine
• Condizione clinica ad elevata probabilità di decesso, secondo Sym-plified Acute Physiology Score (SAPS II)
• Mantenimento parziale della funzionalità renale, definita dagli sta-dio I e II della classificazione KDIGO 2012.

E.5 End points

E.5.1

Primary end point(s)

Colimycin plasma levels after IV infusion

Profilo dei livelli plasmatici della Colimicina dopo infusione EV

E.5.1.1

Timepoint(s) of evaluation of this end point

0 - 12 hours

0 - 12 ore

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

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

E.8.1.1

Randomised

E.8.1.2

Open

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

Yes

E.8.2.3.1

Comparator description

Studio pilota, in aperto, prospettico, monocentrico

This is an open label, single patient group, prospective, single center pilot study

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.8.4.1

Number of sites anticipated in 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

Information not present in EudraCT

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

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

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

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

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.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)

BEST CLINICAL PRACTICE

MIGLIORE PRATICA CLINICA

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

2021-05-31

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-03-18

P. End of Trial
P.	End of Trial Status	Ongoing

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