Clinical Trials Register

Summary
EudraCT Number:	2011-004013-16
Sponsor's Protocol Code Number:	D3720C00001
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2012-07-23
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

Italy - Italian Medicines Agency

A.2

EudraCT number

2011-004013-16

A.3

Full title of the trial

A Phase III, Multicentre, Randomised, Double-Blind, Comparative Study to Evaluate the Efficacy and Safety of Ceftaroline Fosamil (600mg every 8 hours) Versus Vancomycin Plus Aztreonam in the Treatment of Patients With Complicated Bacterial Skin and soft Tissue Infections With Evidence of Systemic Inflammatory Response or Underlying Comorbidities.

Studio comparativo di fase III, multicentrico, randomizzato, in doppio cieco per valutare l'efficacia e la sicurezza di ceftaroline fosamil (600 mg ogni 8 ore) verso vancomicina in combinazione con aztreonam nel trattamento di pazienti affetti da infezioni batteriche complicate della cute e dei tessuti molli con evidente risposta infiammatoria sistemica o comorbidita' sottostanti.

A.3.1

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

Evaluation of Ceftaroline Fosamil versus Vancomycin Plus Aztreonam in the Treatment of Patients With Skin Infections.

Valutazione del trattamento di pazienti con infezioni della cute con Ceftaroline Fosamil verso Vancomicina piu' Aztreonam .

A.3.2

Name or abbreviated title of the trial where available

Ceftaroline Fosamil cSSTI

A.4.1

Sponsor's protocol code number

D3720C00001

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	ASTRAZENECA AB
B.1.3.4	Country	Sweden
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	AstraZeneca AB
B.4.2	Country	Sweden
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	AstraZeneca
B.5.2	Functional name of contact point	Information Centre
B.5.3	Address:
B.5.3.1	Street Address	Rollins 12th Floor, 1800 Concord Pike, PO Box 15437
B.5.3.2	Town/ city	Wilmington
B.5.3.3	Post code	DE 19850-5437
B.5.3.4	Country	United States
B.5.4	Telephone number	+1 800 236 9933
B.5.5	Fax number	+1 302 885 3516
B.5.6	E-mail	information.center@astrazeneca.com

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	TEFLARO
D.2.1.1.2	Name of the Marketing Authorisation holder	Forest Pharmaceuticals Inc.
D.2.1.2	Country which granted the Marketing Authorisation	United States
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	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	CEFTAROLINE FOSAMIL
D.3.9.1	CAS number	229016-73-3
D.3.9.4	EV Substance Code	SUB31648
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	600
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	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.2.1.1.1	Trade name	vancocin
D.2.1.1.2	Name of the Marketing Authorisation holder	Flynn Pharma Ltd
D.2.1.2	Country which granted the Marketing Authorisation	United Kingdom
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 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	Vancomicina
D.3.9.1	CAS number	1404-90-6
D.3.9.4	EV Substance Code	SUB05076MIG
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	1
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.2.1.1.1	Trade name	Azactam
D.2.1.1.2	Name of the Marketing Authorisation holder	E.R Squibb and Sons
D.2.1.2	Country which granted the Marketing Authorisation	United Kingdom
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 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	AZTREONAM
D.3.9.1	CAS number	78110-38-0
D.3.9.4	EV Substance Code	SUB05664MIG
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	1
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
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Solution for infusion
D.8.4	Route of administration of the placebo	Intravenous use
D.8 Placebo: 2
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Solution for infusion
D.8.4	Route of administration of the placebo	Intravenous use
D.8 Placebo: 3
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Solution for infusion
D.8.4	Route of administration of the placebo	Intravenous use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Complicated bacterial skin and soft tissue infections.

Infezioni batteriche complicate della cute e dei tessuti molli

E.1.1.1

Medical condition in easily understood language

Skin infections

Infezioni della cute

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	14.1
E.1.2	Level	HLGT
E.1.2	Classification code	10004018
E.1.2	Term	Bacterial infectious disorders
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

To assess whether ceftaroline fosamil is noninferior to vancomycin plus aztreonam in the clinical cure rate at the test of cure visit in both the modified intent-to-treat and clinically evaluable anlaysis sets of adult patients with complicated skin and soft tissue infections (cSSTI)

L’obiettivo primario consiste nel valutare se il ceftaroline fosamil non è inferiore alla terapia combinata di vancomicina e aztreonam nella percentuale di guarigione clinica alla visita di Prova di cura (“TOC”, Test of Cure ) in entrambi i gruppi dell'analisi Intent-To-Treat modificata (“MITT”) e della popolazione clinicamente valutabile (“CE”, Clinically Evaluable ) di pazienti adulti affetti da cSSTI.

E.2.2

Secondary objectives of the trial

To evaluate the clinical response at the End of Therapy Visit. To evaluate the microbiological response at the End of Therapy and Test of Cure Visits To evaluate the clinical and microbiological response by baseline pathogen at the Test of Cure Visit ·To evaluate superinfection, colonisation and new infection up to TOC and microbiological recurrence and re-infection at LFU ·To evaluate early response to treatment as defined by cessation of lesion spread at 48 to 72 hours of treatment ·To compare the safety and tolerability of ceftaroline fosamil and vancomycin plus aztreonam in patients with cSSTI ·To characterize the pharmacokinetics (PK) and exposure-response relationship of 600 mg of ceftaroline fosamil administered as a 120- minute intravenous (IV) infusion every 8 hours in patients with cSSTI

Gli obiettivi secondari sono:•Valutare la risposta clinica alla visita di Fine Terapia (“EOT”,End of Therapy )•Valutare la risposta microbiologica al termine delle visite EOT e TOC•Valutare la risposta clinica e microbiologica da parte del patogeno isolato alla baseline durante la visita TOC•Valutare la recidiva clinica e la reinfezione o recidiva durante l’Ultima visita di follow-up (LFU)•Valutare la superinfezione,la colonizzazione e la nuova infezione in corrispondenza della TOC e la recidiva microbiologica e la reinfezione durante la LFU•Valutare la risposta precoce al trattamento definita come cessazione dell’espansione delle lesioni da 48 a 72 ore dal trattamento•Confrontare la sicurezza e tollerabilità di ceftaroline fosamil e vancomicina in combinazione con aztreonam nei pazienti affetti da cSSTI•Caratterizzare la farmacocinetica (PK) e il rapporto.....

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Patient must provide a signed written informed consent prior to any study-specific procedures 2. Patient must be a male or female, aged 18 years and older 3. Patient must have one of the following cSSTIs: - Cellulitis: a diffuse skin infection characterised by spreading areas of erythema, oedema, and/or induration of a minimum surface area of 75 cm2 (eg, minimum length of 10 cm and width of 7.5 cm) - Traumatic or surgical wound infection: an infection characterised by purulent drainage/or collection from an injury-related wound or a surgical wound with surrounding erythema, oedema, and/or induration of a minimum surface area of 75 cm2 (eg, the shortest distance of redness, oedema, and/or induration extending at least 5 cm from the peripheral margin of the wound). Appropriate surgical intervention must be completed prior to the first dose of study drug or up to, at most, 48 hours after the first dose of study drug. - Major cutaneous abscess: an infection characterised by a collection of pus within the dermis or deeper that is accompanied by erythema, oedema, and/or induration of a minimum surface area of 75 cm2 (eg, the shortest distance of redness, oedema, and/or induration extending at least 5 cm from the peripheral margin of the abscess). The abscess must undergo incision and drainage prior to the first dose of study drug or up to, at most, 48 hours after the first dose of study drug. The number of patients with major cutaneous abscesses will be limited to no more than30% of the study population. - Burn infection: an infection characterised by purulent drainage, erythema, oedema, and/or induration of a minimum surface area of 75 cm2 (eg, the shortest distance of redness, oedema, and/or induration extending at least 5 cm from the peripheral margin of the burn infection). Burns must involve less than 15% of the body surface area and acquired within 7 days of hospitalisation. Appropriate surgical intervention must be completed prior to the first dose of study drug or up to, at most, 48 hours after the first dose of study drug. 4. Patients must demonstrate at least one of the following criteria (for the first 3 bullets, the criterion must be met within 24 hours prior to first dose of study drug): - Temperature ≥38.0°C (100.4°F) or ≤36.0°C (96.8°F) and/or - White blood cells >12000 cells/mm3 or <4000 cells/mm3 or >10% band forms (immature white blood cells) and/or - Heart rate >90 beats per minute and respiratory rate >20 breaths per minute after 10 minutes of rest and/or - One or more of the following comorbidities: − Diabetes mellitus requiring drug therapy (note: patients with diabetic foot infections are excluded as per exclusion criterion #8) − Stage 2 or 3 HIV infection (per Center for Disease control classification 2008) (note: patients with a CD4 count <150 cell/microliter within 6 months prior to first dose of study drug or suspected opportunistic infection are excluded) − Chronic renal impairment (estimated creatinine clearance ≥20 mL/min to <50 mL/min) as calculated by the Cockcroft-Gault formula − Cirrhosis with Child-Pugh Stage A or B (note: patients with Child-Pugh Stage C are excluded) − cSSTI below the knee associated with peripheral vascular disease diagnosed on the basis of any of the following: claudication at a distance of at least 20 meters; resting ankle-brachial index 0.3 to 0.8; prior femoral artery bypass grafting; or prior aortic aneurysm repair (note: patients with ulcers due to peripheral vascular disease are also excluded) − Albumin <2.5 mg/dL or prealbumin <11 mg/dL in the absence of liver disease − Use of immunosuppressive agents, including a glucocorticoid (Note: patient who is receiving or has received >40 mg per day of prednisone or equivalent for more than 1 week within the 2 weeks prior to study enrolment is excluded) − .......

1. Il paziente deve fornire un consenso informato scritto prima di qualsiasi procedura dello studio 2. Il paziente uomo o donna deve avere 18 anni o più 3. Il paziente deve avere una delle seguenti cSSTIs: - Cellulite: una diffusa infezione della pelle caratterizzata da vaste aree di eritema, edema, e/o indurimento di una superficie minima di 75 cm2 (es. lunghezza minima di 10 cm e larghezza di 7.5 cm) - Infezione da ferita traumatica o chirurgica: un’infezione caratterizzata da spurgo/o raccolta di una ferita traumatica o chirurgica circondata da eritema, edema, e/o indurimento di una superficie minima di 75 cm2 (es. la distanza minima di rossore, edema, e/o indurimento esteso per almeno 5 cm dal margine periferico della ferita). Intervento chirurgico appropriato dev’essere stato completato prima della prima dose di farmaco dello studioo al massimo 48 ore dopo la prima dose di farmaco dello studio. - Ascesso cutaneo importante: un’infezione caratterizzata da raccolta di pus all’interno del derma o sottostante, accompagnata da eritema, edema, e/o indurimento di una superficie minima di 75 cm2 (es. la distanza minima di rossore, edema, e/o indurimento esteso per almeno 5 cm dal margine periferico dell’ascesso). L’ascesso deve aver subito incisione e drenaggio prima della prima dose di farmaco dello studio o al massimo fino a 48 ore dopo la prima dose di farmaco dello studio. Il numero di pazienti con ascessi cutanei importanti verrà limitato a non più del 30% della popolazione dello studio. - Infezione da bruciatura: un’infezione caratterizzata da spurgo purulento, eritema, edema e/o indurimento di una superficie minima di 75 cm2 (es. la distanza minima di rossore, edema, e/o indurimento esteso per almeno 5 cm dal margine periferico della infezione da bruciatura). Le bruciature devono coinvolgere meno del 15% della superficie corporea ed essere avvenute entro 7 giorni dall’ospitalizzazione. Intervento chirurgico appropriato dev’essere completato prima della prima dose di farmaco dello studio o al massimo fino a 48 ore dopo la prima dose di farmaco dello studio. 4. I pazienti devono riportare almeno uno dei seguenti criteri (per i primi 3 punti il criterio dev’essere riportato entro 24 ore prima della prima dose di farmaco dello studio): - temperatura > 38.0°C (100.4°F) o < 36.0°C (96.8°F) e/o - globuli bianchi >12000 globuli/mm3 o <4000 g globuli/mm3 o >10% delle forme a banda (globuli bianchi immaturi) e/o - battito cardiaco >90 battiti al minuto e frequenza respiratoria >20 respiri al minuto dopo 10 minuti di riposo e/o - una o più delle seguenti comorbidità: - diabete mellito che richieda terapia farmacologica (nota: i pazienti con infezioni da diabete al piede sono esclusi secondo il criterio di esclusione # 8) - infezione da HIV di grado 2 o 3 (secondo la classificazione di controllo del 2008 del Centro Malattie) (nota: pazienti con una conta CD4 <150 cellule/microlitro entro 6 mesi prima della prima dose di farmaco dello studio o sospetta infezione opportunistica sono esclusi) - problemi renali cronici (clearance stimata della creatinina da > 20 mL/min a < 50 mL/min) come calcolato dalla formula Cockcroft-Gault - cirrosi con un livello Child-Pugh A o B (nota: pazienti con un livello C Child-Pugh sono esclusi) - cSSTI sotto le ginocchia associata a malattia vascolare periferica diagnosticata sulla base di uno dei seguenti: claudicanza a una distanza di almeno 20 metri; indice caviglia-brachiale a riposo da 0.3 a 0.8; precedente innesto di bypass artereofemorale; o precedente trattamento di aneurisma aortico (nota: pazienti con ulcere dovute a malattia vascolare periferica sono anch’essi esclusi) - albumina < 2.5 mg/dL o prealbuma < 11 mg/dL in assenza di malattia al fegato - uso di agenti immunosoppressori, incluso glucocorticoidi (nota: pazienti che stanno ricevendo o hanno ricevuto > 40 ......

E.4

Principal exclusion criteria

. Received systemic antibacterial drugs for greater than 24 hours within 96 hours prior to first dose of study drug . Uncomplicated skin and skin structure infections, skin infections suspected to be caused by viral or fungal pathogens . Diabetes, diabetic foot infections, decubitus ulcers, ulcers due to peripheral vascular disease . Infection caused by human or animal bites, sternal wound infections, bone infection or arthritis due to an infection, critical limb ischemia of the affected limb . Chronic liver disease or severe impaired renal function, severe low white blood cell count, burns on greater than 15% of total body surface area, necrotizing skin infection, amputation required of primary site of infection, sustained shock.

- Aver ricevuto farmaci sistemici antibatterici per più di 24 ore entro le 96 ore precedenti la prima dose di farmaco dello studio - Infezioni non complicate di cute e struttura della cute, infezioni della cute di sospetta origine virale o da funghi patogeni - Diabete, infezioni da diabete ai piedi, ulcere da decubito, ulcere causate da malattia vascolare periferica - Infezione causata da morsi umani o animali, infezioni di ferite allo sterno, infezione delle ossa o artrite causata da un’infezione, ischemia critica dell’arto malato - Malattia cronica al fegato o funzione renale gravemente ridotta, conta di globuli bianchi fortemente ridotta, ustioni di una estensione superiore al 15% della superficie totale del corpo, infezioni dellacute necrotizzanti, amputazione necessaria per il sito principale d’infezione, shock prolungato

E.5 End points

E.5.1

Primary end point(s)

To assess the clinical cure rate in both the modified intent-to-treat and clinically evaluable analysis sets.

La variabile primaria dell’esito è data dalla percentuale di guarigione clinica alla visita TOC in entrambi i gruppi di analisi MITT e CE.

E.5.1.1

Timepoint(s) of evaluation of this end point

At the test of cure visit

Alla visita TOC.

E.5.2

Secondary end point(s)

The secondary outcome variables will include the following: • Clinical cure rate at the EOT visit in the MITT and CE analysis sets • Per-patient microbiological response at the EOT and TOC visits in the microbiological modified intent-to-treat (mMITT) and ME analysis sets • Clinical and per-pathogen microbiological response by baseline pathogen at the TOC visit in the mMITT and ME analysis sets • Clinical relapse at the LFU visit in patients who were clinically cured at the TOC visit in the CE analysis set • Re-infection and the recurrence rate in patients who were microbiological successes at the TOC visit in the ME analysis set Super-infection rate at the EOT visit and new infection rate at the TOC visit in the ME analysis set • Colonisation rate in patients who had a clinical assessment performed at the EOT visit or the TOC visit in the ME analysis set • Evaluation of early response at 48 to 72 hours of treatment in the MITT and CE analysis sets

Le variabili secondarie dell’esito includono quanto segue: • Percentuale di guarigione clinica alla visita EOT nei gruppi di analisi MITT e CE • Risposta microbiologica per paziente alle visite EOT e TOC nei gruppi di analisi microbiologica Intent-To-Treat modificata (mMITT) e ME • Risposta clinica e microbiologica per patogeno, per patogeno isolato alla baseline durante la visita TOC nei gruppi di analisi mMITT e ME • Recidiva clinica durante la visita LFU nei pazienti che sono stati curati clinicamente durante la visita TOC nel gruppo di analisi CE • Percentuale di reinfezione e recidiva nei pazienti definiti successi microbiologici durante la visita TOC nel gruppo di analisi ME • Percentuale di superinfezione durante la visita EOT e nuova percentuale di infezione durante la visita TOC nel gruppo di analisi ME • Percentuale di colonizzazione nei pazienti che sono stati sottoposti a una valutazione clinica durante la visita EOT o visita TOC nel gruppo di analisi ME • Valutazione della risposta precoce nel periodo compreso tra le 48 e le 72 ore dal trattamento nei gruppi di analisi MITT e CE

E.5.2.1

Timepoint(s) of evaluation of this end point

1. at the end of therapy visit
2. at the end of therapy and test of cure visits
3. at the test of cure visit
4. at the late follow-up visit
5. at the late follow up visit
6. at the end of therapy visit
7. at the end of therapy visit or the test of cure visit
8. at 48 to 72 hours of treatment

1) Alla visita di fine trattamento (EOT)
2)Alla visita EOT ed alla visita di "prova di cura" (TOC)
3) Alla visita TOC
4) All'ultima visita di follow up
5) All'ultima visita di follow up
6) Alla visita EOT
7) Alla visita EOT ed alla visita TOC
8) a 48 e 72 ore dal tratamento.

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

Yes

E.6.5

Efficacy

Yes

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)

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

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

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)

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

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

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Argentina

Australia

Brazil

Chile

Colombia

Hong Kong

Israel

Korea, Republic of

Mexico

Peru

Philippines

Russian Federation

South Africa

Switzerland

Taiwan

Turkey

Ukraine

United States

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

Number of subjects for this age range:

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:

385

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

380

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.4.2

For a multinational trial

F.4.2.1

In the EEA

220

F.4.2.2

In the whole clinical trial

765

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)

After participation in the trial, if applicable, patients will be treated with the current standard therapy.

Se applicabile, al termine dello studio il paziente sarà trattato secondo la normale 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

2012-05-22

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-04-17

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

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IMP with orphan designation in the indication
Orphan Designation Number:
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