Clinical Trials Register

Summary
EudraCT Number:	2014-003137-25
Sponsor's Protocol Code Number:	ODAPE
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:	2014-10-16
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

Spain - AEMPS

A.2

EudraCT number

2014-003137-25

A.3

Full title of the trial

Optimal duration of antibiotic treatment in patients with complicated parapneumonic pleural effusions or empyema: a randomized clinical trial

Duración óptima del tratamiento antibiótico en pacientes con derrame pleural paraneumónico complicado o empiema: ensayo clínico randomizado

A.3.1

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

Optimal duration of antibiotic treatment in patients with complicated parapneumonic pleural effusions or empyema

Duración óptima del tratamiento antibiótico en pacientes con derrame pleural paraneumónico complicado o empiema

A.3.2

Name or abbreviated title of the trial where available

ODAPE

A.4.1

Sponsor's protocol code number

ODAPE

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	José Manuel Porcel Pérez Hospital Arnau de Vilanova de Lleida Servicio Medicina Interna
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	José Manuel Porcel Pérez Hospital Arnau de Vilanova de Lleida Servicio Medicina Interna
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	José Manuel Porcel Pérez Hospital Arnau de Vilanova de Lleida Servicio Medicina Interna
B.5.2	Functional name of contact point	Inv.
B.5.3	Address:
B.5.3.1	Street Address	Rovira Roure 80
B.5.3.2	Town/ city	Lleida
B.5.3.3	Post code	25198
B.5.3.4	Country	Spain
B.5.4	Telephone number	+34973705236
B.5.5	Fax number	+34973248754
B.5.6	E-mail	jporcelp@yahoo.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.2.1.1.1	Trade name	Ardineclav 875mg/125mg
D.2.1.1.2	Name of the Marketing Authorisation holder	Reig Jofré, S.A.
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.3.4	Pharmaceutical form	Powder for use in drinking water
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	CLAVULANIC ACID
D.3.9.1	CAS number	58001-44-8
D.3.9.2	Current sponsor code	Reig Jofré, S.A.
D.3.9.4	EV Substance Code	SUB06642MIG
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	125
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	AMOXICILIN
D.3.9.1	CAS number	26787-78-0
D.3.9.2	Current sponsor code	Reig Jofré, S.A.
D.3.9.4	EV Substance Code	SUB05481MIG
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	875
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	Powder for use in drinking water
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

Duration of antibiotic treatment in complicated parapneumonic pleural effusion and empyema.

Duración del tratamiento antibiótico en el derrame pleural paraneumónico complicado y empiema.

E.1.1.1

Medical condition in easily understood language

Duration of antibiotic treatment in complicated parapneumonic pleural effusion and empyema.

Duración del tratamiento antibiótico en el derrame pleural paraneumónico complicado y empiema.

E.1.1.2

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

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

-To show that antibiotic treatment for 2 weeks is non-inferior to 3 weeks of treatment in patients with complicated parapneumonic pleural effusion or empyema.

-Demostrar la no inferioridad de un régimen antibiótico de 2 frente a 3 semanas en pacientes con DPPC o empiema.

E.2.2

Secondary objectives of the trial

To assess the impact of adjuvant treatment with NSAIDs in clinical and radiological resolution of DPPC or empyema.

Valorar la influencia del tratamiento adyuvante con AINEs, en la resolución radiológica y clínica del DPPC o empiema.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

-18 years of age or older

-Clinical evidence of CPPE; defined as a neutrophilic exudated in the context of

a community acquired pneumonia; or empyema, defined as the presence of pus

in pleural cavity. A CPPE required, according to the attending physician, a chest

tube drainage. Most patients will satisfy the following criteria: 1) pleural fluid

pH < 7.2 or pleural fluid glucose < 60 mg/dL, 2) Gram-positive or pleural fluid

positive culture or 3) pleural effusion that occupy 50% or more of a hemithorax

in a thorax radiography or it is loculated in an image exploration (radiography,

ultrasound or computed tomography).

-Clinical stability 2 weeks after diagnosis and antibiotic therapy beginning,

defined as: 1) absence of fever (temperature < 37.8oC), heart rate < 100 bpm,

breath rate < 24 bpm and systolic blood pressure > 90 mmHg. 2) Thorax

radiography without pleural effusion or that occupy less than 20% of the

hemithorax without chest tube in that moment. 3) Serum C-reactive protein drop

of at least 50% from the diagnosis.

-Capable of giving written informed consent.
3. Clinical stability at 2 weeks of diagnosis and treatment with amoxicillin-clavulanate of DPPC or empyema. This must meet three requirements: 1) in the past 48 hours: T ª <37.8 ° C, HR <100 bpm FR <24 rpm and SBP> 90 mmHg, 2) pleural effusion on chest radiograph occupying less than 20% of the hemithorax with pleural drainage and retired at the time, and 3) decrease in serum C-reactive protein of at least 50% from diagnosis.

1. Pacientes mayores de 18 años

2.Evidencia clínica de DPP, definido como un exudado

polimorfonuclear en el contexto de una neumonía comunitaria.

Empiema es la presencia de pus en la cavidad pleural. El DPPC

se define como aquel líquido no purulento que requiere, a criterio

del clínico, la inserción de un drenaje pleural. La mayoría de estos

pacientes cumplirán alguno de los siguientes criterios: 1) pH del

líquido pleural < 7.2 o glucosa < 60 mg/dL, 2) Gram o cultivo positivo

del líquido pleural, o 3) derrame pleural que ocupa el 50% o más

del hemitórax en la radiografía de tórax, o que está loculado en una

prueba de imagen (Rx, ecografía o TC).

3. Estabilidad clínica a las 2 semanas del diagnóstico y tratamiento

con amoxicilina-clavulánico del DPPC o empiema. Para ello se deben cumplir

tres requisitos: 1) en las últimas 48 horas: Ta <37,8oC, FC <100 lpm, FR<24

rpm y TAS>90 mmHg, 2) derrame pleural en la radiografía de tórax que

ocupe menos del 20% del hemitórax con el drenaje pleural ya retirado en ese

momento, y 3) descenso de la proteína C reactiva sérica de al menos el 50%

desde el diagnóstico.

E.4

Principal exclusion criteria

-Pregnant women

-Allergy for amoxicillin clavulanate

-Immunosuppression: neutropenia, HIV infection, haematological neoplasms,

solid-organ transplantation or steroids or immunosuppressive treatments.

-Tuberculous pleural infection

-Nosocomial-, nursinghome- or healthcare-associated pneumonia.

-Infection due to microorganisms that require alternative therapeutic regimens.

-Life expectancy less than three months due to other causes.7. Expected survival less than 3 months from other causes
8. Patients who did not sign the informed consent

1. Mujeres embarazadas

2. Pacientes alérgicos a amoxicilina-clavulánico

3. Pacientes inmunodeprimidos: neutropenia, infección VIH, neoplasias

hematológicas, transplantes de órgano sólido o tratamientos corticoideo o

inmunosupresor.

4. Infección pleural tuberculosa

5. Neumonía nosocomial o asociada a cuidados sanitarios

6. Crecimiento en el líquido pleural de gérmenes resistentes a la

amoxicilina-clavulánico

7. Supervivencia esperada inferior a 3 meses por otras causas

8. Pacientes que no firmen el consentimiento informado7. Supervivencia esperada inferior a 3 meses por otras causas
8. Pacientes que no firmen el consentimiento informado

E.5 End points

E.5.1

Primary end point(s)

?healing?: clinical and radiological resolution 3 months alter the beginning

of the antibiotic treatment and without pleural infection symptoms or signs .

?curación?: resolución clínica y radiológica a los 3 meses desde el inicio

del tratamiento antibiótico y no haya existido recurrencia de síntomas o signos

de infección pleural.

E.5.1.1

Timepoint(s) of evaluation of this end point

Three months after the beginning of the antibiotic treatment.

A los tres meses del inicio del tratamiento antibiótico.

E.5.2

Secondary end point(s)

Evaluation of the residual pleural thickening

Evaluación del engrosamiento pleural residual

E.5.2.1

Timepoint(s) of evaluation of this end point

Three months after the beginning of the antibiotic treatment.

A los tres meses del inicio del tratamiento antibiótico.

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)

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

Yes

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

Follow-up visit within 90 days of discharge

Visita de seguimiento a los 3 meses del inicio del tratamiento

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:

100

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

100

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

200

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)

Nothing

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

2014-12-26

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2014-11-06

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

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