Clinical Trials Register

Summary
EudraCT Number:	2011-002977-44
Sponsor's Protocol Code Number:	ASAA-Study
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:	2012-03-07
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

2011-002977-44

A.3

Full title of the trial

Antibiotics vs Surgery in Acute Appendicitis: an intention to treat prospective randomised controlled study, The ASAA-Study

A.3.1

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

The study is an intention to treat prospective randomized controlled study; due to the characteristic of the study (surgery vs. no surgery) it is no blind for the patients as well for the surgeon

Confrontare in maniera prospettica e randomizzata il trattamento antibiotico con Ertapenem vs. chirurgia

A.3.2

Name or abbreviated title of the trial where available

ASAA-Study

A.4.1

Sponsor's protocol code number

ASAA-Study

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	AZIENDA OSPEDALIERA "OSPEDALI RIUNITI DI BERGAMO" (A.O. DI RILIEVO NAZIONALE)
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	A.O OSPEDALI RIUNITI DI BERGAMO
B.4.2	Country	Italy
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	AZIENDA OSPEDALIERA
B.5.2	Functional name of contact point	Segreteria Comitato di Bioetica
B.5.3	Address:
B.5.3.1	Street Address	L.GO BAROZZI, 1
B.5.3.2	Town/ city	BERGAMO
B.5.3.3	Post code	24128
B.5.3.4	Country	Italy
B.5.4	Telephone number	035-266913
B.5.5	Fax number	035-266675
B.5.6	E-mail	segrcomitatodibioetica@ospedaliriuniti.bergamo.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.2.1.1.1	Trade name	INVANZ*EV FL 1G 20ML
D.2.1.1.2	Name of the Marketing Authorisation holder	MERCK SHARP & DOHME SpA
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.3.4	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	ERTAPENEM
D.3.9.1	CAS number	153832-46-3
D.3.9.2	Current sponsor code	NA
D.3.9.3	Other descriptive name	ERTAPENEM
D.3.9.4	EV Substance Code	SUB25388
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: 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	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.3.4	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	AMOXICILLIN
D.3.9.1	CAS number	26787-78-0
D.3.9.2	Current sponsor code	NA
D.3.9.3	Other descriptive name	Amoxicilin
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.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	CLAVULANIC ACID
D.3.9.1	CAS number	61177-45-5
D.3.9.2	Current sponsor code	NA
D.3.9.3	Other descriptive name	Clavulanic Acid
D.3.9.4	EV Substance Code	SUB06642MIG
D.3.10	Strength
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	125
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

All the patients between 18 and 65 years old admitted to the hospital with a first episode of suspected acute appendicitis diagnosed by Andersson's score

Pazienti tra i 18 e 65 anni di età con elevato indice di sospetto di appendicite acuta allo score di Andersson

E.1.1.1

Medical condition in easily understood language

Appendicite acuta

E.1.1.2

Therapeutic area

Diseases [C] - Digestive System Diseases [C06]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.1
E.1.2	Level	LLT
E.1.2	Classification code	10000677
E.1.2	Term	Acute appendicitis
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

The study is an intention to trat prospective randomized controlled study; due to the characteristic of the study (surgery vs. no surgery) it is no blind for the patients as well for the surgeon.

Lo studio si propone di confrontare in maniera prospettica e randomizzata il trattamento antibiotico con Ertapenem vs Chirurgia in una popolazione compresa tra 18-65 anni di età con elevato indice di sospetto di appendicite acuta allo score di Andersson

E.2.2

Secondary objectives of the trial

N.A

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

All the patients between 18 and 65 years old admitted to the hospital with a first episode of suspected acute appendicitis diagnosed by Andersson's score

Pazienti tra i 18 e 65 anni di età con elevato indice di sospetto di appendicite acuta allo score di Andersson

E.4

Principal exclusion criteria

Patient with any potential immunodeficiency status (diseases or syndromes, neoplasia in the last five years), assumption of antibiotics for different infectious disease or surgery in the last 30 days, allergy to antibiotics established in the study protocol, no acceptance of study protocol, pregnancy or delivery in the last 6 months, ASA IV or V, no Italian or English fluently speakers.

Pazienti con stati di potenziale immunodeficienza (malattie o sindromi, neoplasia negli ultimi 5 anni), assunzione di antibiotici per differenti infezioni o pratiche chirurgiche negli ultimi 30 giorni, allergia conosciuta verso antibiotici utilizzati nello studio, donne in gravidanza o che hanno partorito negli ultimi 6 mesi, ASA IV, V, pazienti che non parlano italiano od inglese fluentemente.

E.5 End points

E.5.1

Primary end point(s)

Evaluation in both arms of the rate of patients free of symptoms into 2 weeks (from operation in the surgery group or from the third Ertapenem administration in the antibiotics group) with no pain, no fever, WBC<10000, CRP<1

Outcome primario: assenza di sintomatologia a 2 settimane: assenza di dolore, febbre, conteggio dei globuli bianchi <10000 e PCR<1

E.5.1.1

Timepoint(s) of evaluation of this end point

Two weeks

Due settimane

E.5.2

Secondary end point(s)

Secondary outcomes will be considered major complication occuring after 2 weeks ant into 1 year. Moreover secondary outcomes will bel considered any minor complications at any time: wound infection, negative appendectomy. Secondary outcomes will be also considered hospital stay and work absence.

Outcome secondari sono da considerarsi le complicanze maggiori che capiteranno dopo 2 settimane ed entro 1 anno; le complicanze minori: infezione di ferita e appendicectomie negative. Ulteriori outcomes secondari sono la legenza ospedaliera, l'assenza dal lavoro, il dolore.

E.5.2.1

Timepoint(s) of evaluation of this end point

Beetwen two weeks and one year.

Da due settimane a 1 anno

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)

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

Yes

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

Intervento chirurgico + antibiotico

surgery + antibiotic

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 study will be stopped in case that at the interim analysis, done after the inclusion of the first 109 patients, primary outcome will be already significantly different.

Lo studio verrà interrotto nel caso in cui l'analisi ad interim, effettuata dopo l'inserimento dei primi 109 pazienti, l'end point primario sarà già significativamente differente.

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

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:

218

F.1.3

Elderly (>=65 years)

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

218

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)

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

2011-06-28

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2011-06-16

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

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