Clinical Trials Register

Summary
EudraCT Number:	2017-001406-15
Sponsor's Protocol Code Number:	NACATB
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2018-04-09
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

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Spain - AEMPS

A.2

EudraCT number

2017-001406-15

A.3

Full title of the trial

Adequate duration of antibiotic treatment in community acquired pneumonia categorized by pneumonia severity index (PSI)

Duración adecuada del tratamiento antibiótico en la neumonía adquirida en la comunidad categorizada por escala de severidad PSI

A.3.1

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

Assess the optimal duration of pneumonia antibiotic treatment

Determinar la duración óptima del tratamiento antibiótico de la neumonía

A.4.1

Sponsor's protocol code number

NACATB

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	Fundació Clínic per la Recerca Biomèdica
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	Fundació Clínic per la Recerca Biomèdica
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	Fundació Clínic per la Recerca Biomèdica
B.5.2	Functional name of contact point	Adrian Ceccato
B.5.3	Address:
B.5.3.1	Street Address	c/ Villarroel 170
B.5.3.2	Town/ city	Barcelona
B.5.3.3	Post code	08003
B.5.3.4	Country	Spain
B.5.4	Telephone number	+3493227.54.00
B.5.6	E-mail	ACECCATO@clinic.cat

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	Actira
D.2.1.1.2	Name of the Marketing Authorisation holder	Laboratorios Cinfa
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	Moxifloxacin
D.3.4	Pharmaceutical form	Film-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	Moxifloxacin
D.3.9.1	CAS number	151096-09-2
D.3.9.2	Current sponsor code	Moxifloxacin
D.3.9.3	Other descriptive name	MOXIFLOXACIN
D.3.9.4	EV Substance Code	SUB09086MIG
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	400
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	Film-coated tablet
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Community Acquired Pneumonia

Neumonía adquirida en la comunidad

E.1.1.1

Medical condition in easily understood language

Pneumonia

Neumonía

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	20.1
E.1.2	Level	LLT
E.1.2	Classification code	10010120
E.1.2	Term	Community acquired pneumonia
E.1.2	System Organ Class	100000004862

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 evaluate the efficacy of 5-day antibiotic treatment compared to the usual treatment for more than 7 days in terms of treatment failure, during the 30 days after the day of hospital admission, in patients with Community Acquired Pneumonia with a PSI IV-V severity score that present an adequate initial response according to the criteria of Halm et al (clinical stability before the 4th day after admission).

Evaluar la eficacia del tratamiento antibiótico durante 5 días comparado con el tratamiento habitual durante más de 7 días en términos de fracaso de tratamiento durante los 30 días posteriores al día de admisión hospitalaria en pacientes con NAC con un score de severidad PSI IV-V(18) que presenten una adecuada respuesta inicial según criterios de Halm et al.(15) (estabilidad clínica antes del 4º día desde la admisión).

E.2.2

Secondary objectives of the trial

1. To evaluate the efficacy of 5-day antibiotic treatment compared to the usual treatment for more than 7 days in terms of time of hospital stay and antibiotic-free days during the first 30 days after hospital admission in the same selected population

2. To evaluate the safety of antibiotic treatment for 5 days compared to the usual treatment for more than 7 days in the same selected population

1. Evaluar la eficacia del tratamiento antibiótico durante 5 días comparado con el tratamiento habitual durante más de 7 días en términos de tiempo de estancia hospitalaria y días libres de antibióticos durante los 30 días posteriores al día de admisión hospitalaria en la misma población seleccionada.

2. Evaluar la seguridad del tratamiento antibiótico durante 5 días comparado con el tratamiento habitual durante más de 7 días en la misma población seleccionada.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1) Hospitalized patients diagnosed with Community Acquired Pneumonia: appearance of a new radiological infiltrate plus the presence of at least two of the following signs or symptoms: fever (> 38 ºC), cough, expectoration, chest pain, dyspnea or tachypnea, and signs of occupation of the alveolar space.
2) A PSI score class IV or V.
3) Patients who have received adequate antibiotic treatment according to clinical guidelines from the first hour of emergency room admission.
4) Patients who achieve clinical stability: temperature ≤37.2 ºC, heart rate ≤100 beats / min, respiratory rate ≤24 breaths / min, systolic blood pressure> 90 mmHg; oxygen saturation> 90%; or oxygen blood pressure> 60 mmHg (15) before the fourth day.
5) Signature of informed consent.

1) Pacientes hospitalizados con diagnóstico de NAC: aparición de un nuevo infiltrado radiológico más la presencia de al menos dos de los siguientes signos o síntomas: fiebre (>38 ºC), tos, expectoración, dolor torácico, disnea o taquipnea, y signos de ocupación del espacio alveolar.
2) Que presenten un score PSI clase IV o V.
3) Pacientes que hayan recibido tratamiento antibiótico adecuado según guías clínicas desde la primera hora de ingreso a urgencias.
4) Pacientes que alcancen estabilidad clínica: temperatura ≤37.2 ºC, frecuencia cardíaca ≤100 latidos / min, frecuencia respiratoria ≤24 respiraciones / min, presión arterial sistólica >90 mmHg; saturación de oxígeno >90%; o presión arterial del oxígeno >60 mmHg (15) antes del cuarto día.
5) Firma del consentimiento informado.

E.4

Principal exclusion criteria

1) Immunosuppression: Coinfection with HIV and presence of AIDS, neutropenic or have received immunosuppressive treatment for any cause. Patients with chronic use of corticosteroids (prednisone or its equivalent)> 10 mg / day for 14 days.
2) Patients hospitalized in the previous 14 days.
3) Suspected multi-resistant germs of any cause.
4) Hypersensitivity or alterations in the tendons associated with the fuoroquinolones.
5) Pregnancy or lactation

1) Inmunodepresión: Co infección con VIH y presencia de SIDA, neutropenicos o que hayan recibido tratamiento inmunosupresor por cualquier causa. Pacientes con uso crónico de corticoides (prednisona o su equivalente) >10 mg/día por 14 días.
2) Pacientes hospitalizados en los 14 días previos.
3) Sospecha de gérmenes multiresistentes de cualquier causa.
4) Hipersensibilidad o alteraciones en los tendones asociadas a las fuoroquinolonas.
5) Embarazo o lactancia.

E.5 End points

E.5.1

Primary end point(s)

Rate of treatment failure during the first 30 days after hospital admission:
- Death for any reason during the first 30 days after hospital admission.
- Hospital re-admission for any reason during the first 30 days after the day of hospital admission.
- Restart antibiotic treatment for any reason during the first 30 days after hospital admission.

Tasa de fracaso de tratamiento durante los 30 días posteriores al día de admisión hospitalaria:
- Muerte por cualquier causa durante los 30 días posteriores al día de admisión hospitalaria.
- Reingreso hospitalario por cualquier causa durante los 30 días posteriores al día de admisión hospitalaria.
- Reinicio de tratamiento antibiótico por cualquier causa durante los 30 días posteriores al día de admisión hospitalaria.

E.5.1.1

Timepoint(s) of evaluation of this end point

30 days

30 días

E.5.2

Secondary end point(s)

Length of hospital stay

Antibiotic-free days

Adverse events (AE)

Serious adverse events (SAE)

Tiempo de estancia hospitalaria.

Días libre de antibióticos

Acontecimientos adversos (AA).

Acontecimientos adversos graves (AAG).

E.5.2.1

Timepoint(s) of evaluation of this end point

60 days

60 días

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

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

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

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

Yes

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

Last visit of the last subject undergoing the trial

El final del estudio quedará establecido en la última visita del último sujeto reclutado.

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

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:

212

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

212

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

424

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

Ninguno

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

2018-07-19

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2018-06-15

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

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials