Clinical Trials Register

Summary
EudraCT Number:	2013-000511-24
Sponsor's Protocol Code Number:	FPS-COL-2013-06
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2013-03-06
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

Spain - AEMPS

A.2

EudraCT number

2013-000511-24

A.3

Full title of the trial

Efficacy of short duration sequential therapy versus standard intravenous therapy for patients with uncomplicated catheter related bacteremia due to S. aureus methicillin-susceptible.

EFICACIA DE UNA TERAPIA SECUENCIAL DE CORTA DURACIÓN VERSUS
TRATAMIENTO INTRAVENOSO ESTÁNDAR PARA PACIENTES CON BACTERIEMIA NO COMPLICADA ASOCIADA A CATÉTER POR S. aureus METICILIN-SENSIBLE.

A.3.1

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

Efficacy of short duration sequential therapy versus standard intravenous therapy for patients with uncomplicated catheter related bacteremia due to S. aureus methicillin-susceptible.

EFICACIA DE UNA TERAPIA SECUENCIAL DE CORTA DURACIÓN VERSUS
TRATAMIENTO INTRAVENOSO ESTÁNDAR PARA PACIENTES CON BACTERIEMIA NO COMPLICADA ASOCIADA A CATÉTER POR S. aureus METICILIN-SENSIBLE.

A.3.2

Name or abbreviated title of the trial where available

FPS-COL-2013-06

A.4.1

Sponsor's protocol code number

FPS-COL-2013-06

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	FUNDACIÓN PÚBLICA ANDALUZA PROGRESO Y SALUD
B.1.3.4	Country	Spain
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	Consejería de Salud y Bienestar Social
B.4.2	Country	Spain
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	FUNDACIÓN PÚBLICA ANDALUZA PROGRESO Y SALUD
B.5.2	Functional name of contact point	Maria del Mar Benjumea Vargas
B.5.3	Address:
B.5.3.1	Street Address	Avda. Américo Vespucio 5, bloque 2, 2º planta
B.5.3.2	Town/ city	Sevilla
B.5.3.3	Post code	41092
B.5.3.4	Country	Spain
B.5.4	Telephone number	0034955040460
B.5.5	Fax number	0034955040457
B.5.6	E-mail	maria.benjumea@juntadeandalucia.es

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	Spain
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	LEVOFLOXACINO
D.3.4	Pharmaceutical form	Coated tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	LEVOFLOXACIN
D.3.9.1	CAS number	100986-85-4
D.3.9.4	EV Substance Code	SUB08471MIG
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.2.1.2	Country which granted the Marketing Authorisation	Spain
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	CLOXACILIN
D.3.4	Pharmaceutical form	Powder and solvent for solution for injection
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	CLOXACILLIN
D.3.9.1	CAS number	61-72-3
D.3.9.4	EV Substance Code	SUB06780MIG
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: 3
D.1.2 and D.1.3	IMP Role	Comparator
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	Spain
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	CLOXACILIN
D.3.4	Pharmaceutical form	Powder and solvent 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	CLOXACILLIN
D.3.9.1	CAS number	61-72-3
D.3.9.4	EV Substance Code	SUB06780MIG
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	500
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

Non complicated Catheter related S. aureus meticillin sensible bacteremia

Bacteriemia no complicada por S. aureus sensible a meticilina

E.1.1.1

Medical condition in easily understood language

Non complicated Catheter related S. aureus meticillin sensible bacteremia

Bacteriemia no complicada por S. aureus sensible a meticilina

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

Assess the eficacy of a sequential regimen of 14 days in patients with catheter-related bacteremia by S. aureus methicillin susceptible, selected based on a set of pre-established criteria equals the pattern of the conventional intravenous

Verificar que la efectividad de una pauta terapéutica secuencial de 14 días en pacientes con bacteriemia asociada a catéter por S. aureus sensible a meticilina, seleccionados en base a una serie de criterios pre-establecidos es igual a la de la pauta intravenosa convencional

E.2.2

Secondary objectives of the trial

Reduce hospital stay associated with the treatment of uncomplicated bacteremia S. aureus.

Increasing efficiency in the management of patients with bacteremia by S. aureus MS, reducing the number of echocardiographic evaluation.

Reducir la estancia hospitalaria asociada al tratamiento de la bacteriemia no complicada por S. aureus.

Aumentar la eficiencia en el manejo de los pacientes con bacteriemia por S. aureus MS, reduciendo el número de pruebas ecocardiográficas.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

? Patients ? 18 years with a minimum weight of 40 kg.
? Microbiological isolation of S. aureus susceptible to methicillin.
? To start antibiotic treatment with drugs active against S. aureus within 72 hours from the onset of clinical manifestations.
? Prescription of treatment must be prior, independent and decoupled patient inclusion in the study, corresponding exclusively to clinical practice.

? Pacientes ? 18 años con un peso mínimo de 40 kg.
? Aislamiento microbiológico de S. aureus sensible a meticilina.
? Inicio de tratamiento antibiótico con fármacos activos frente a S. aureus antes de 72 horas desde el inicio de las manifestaciones clínicas.
? Prescripción del tratamiento tiene que ser previa, independiente y disociada a la inclusión del paciente en el estudio, correspondiéndose exclusivamente a la práctica clínica habitual.

E.4

Principal exclusion criteria

? Polymicrobial bacteremia.
? Neutropenic patients.
? Patients addicted to intravenous drugs.
? Patients with malignancies with expected survival less than 6 months.
? Severe allergy to beta-lactams.
? Creatinine clearance <20ml/min.
? Need for hemodialysis, peritoneal dialysis or plasmapheresis.
? Clinical signs of deep infection in the first five days of treatment (mucocutaneous lesions suggestive of IE, embolic events, suppurative thrombophlebitis.
? Predictors of complicated bacteremia:
Positive blood culture for 48-96 hours of starting treatment antistaphylococcal
Clinical instability
Signs of sepsis or persistent fever on day 4 of treatment
Existence of joint prostheses or valvular or vascular, vascular catheter not removed within three days
Underlying heart disease or endocarditis.
? Patients who present at diagnosis concomitant infection by another organism.
? Not have signed informed consent.

? Bacteriemia polimicrobiana.
? Pacientes neutropénicos.
? Pacientes adictos a drogas por vía parenteral.
? Pacientes portadores de neoplasias con supervivencia esperada inferior a 6 meses.
? Alergia severa a betalactámicos.
? Aclaramiento de creatinina < 20mL/min.
? Necesidad de hemodiálisis, diálisis peritoneal o plasmaféresis.
? Signos clínicos de infección profunda en los primeros cinco días de tratamiento (lesiones mucocutáneas sugestivos de EI, manifestaciones embolicas, tromboflebitis supurada.
? Factores predictores de bacteriemia complicada:
o Hemocultivos positivos a las 48-96 horas de iniciar tratamiento antiestafilocócico
o Inestabilidad clínica
o Signos de sepsis o persistencia de la fiebre al 4º día de tratamiento
o Existencia de prótesis articulares valvulares o vasculares, catéter vascular no retirado en menos de 3 días
o Cardiopatía predisponente para endocarditis.
? Pacientes que presenten al diagnóstico una infección concomitante por otro microorganismo.
? No haber firmado el consentimiento informado.

E.5 End points

E.5.1

Primary end point(s)

Reduce the rate of late complications of catheter-related bacteremia by S. aureus methicillin susceptible below 2%.

Reducir la tasa de complicaciones tardía de la bacteriemia asociada a catéter por S. aureus meticilin sensible por debajo de un 2%.

E.5.1.1

Timepoint(s) of evaluation of this end point

14 days of treatment
6 months after extraction of hemoculture

Catorce días tras el completar el tratamiento

6 meses tras la extracción de hemocultivos

E.5.2

Secondary end point(s)

Mortality rate evaluated at 7, 14 and 30 days

Recovery rate: Evaluated at

At the end of treatment (14 days)
At the end of follow-up period (6 month)

Mortalidad a corto y medio plazo (7, 14 y 30 días).

Curación: Se evaluará en dos momentos:
1) Al final del tratamiento (ausencia de síntomas y signos de infección activa al final del tratamiento, en pacientes cuyos hemocultivos se negativizaron a las 72h)
2) A los 6 meses del mismo (ausencia de complicación tardía).

E.5.2.1

Timepoint(s) of evaluation of this end point

Mortality rate evaluated at 7, 14 and 30 days

Recovery rate: Evaluated at

At the end of treatment (14 days)
At the end of follow-up period (6 month)

ortalidad a corto y medio plazo (7, 14 y 30 días).

Curación: Se evaluará en dos momentos:
1) Al final del tratamiento (ausencia de síntomas y signos de infección activa al final del tratamiento, en pacientes cuyos hemocultivos se negativizaron a las 72h)
2) A los 6 meses del mismo (ausencia de complicación tardía).

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

Yes

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)

Yes

E.7.4

Therapeutic use (Phase IV)

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)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

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

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

The last visit of the last subject

Última visita de seguimiento del último paciente

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:

124

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

154

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

No hay tratamiento post-ensayo dado que es una infección aguda.

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

2013-05-12

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2013-05-06

P. End of Trial
P.	End of Trial Status	Completed

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